Pfizer
Psychological symptom reports
Female, 60 - 75 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 60 | 2021-01-04 | abnormal behaviour |
Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her hist...
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Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.
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| 60 | 2021-01-05 | feeling abnormal |
Rec'd Covid vaccine after 15 min obs stated she felt "swooney, dizzy, like" BP 168/86 HR 68 states s...
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Rec'd Covid vaccine after 15 min obs stated she felt "swooney, dizzy, like" BP 168/86 HR 68 states she has a hx of HTN she usually runs 120's/70's Monitored for another 25 min BP ranging 157/87 - 173/86, prior to leaving states she was not feeling dizzy anymore BP 164/88 HR 69, and wanted to go back to work. Could not find anyone to take care of her patients and was concerned. Coworker states they would monitor her.
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| 60 | 2021-01-05 | feeling abnormal |
19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Clust...
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19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue
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| 60 | 2021-01-05 | feeling abnormal |
Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscl...
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Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20
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| 60 | 2021-01-05 | impaired work ability |
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b...
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Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
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| 60 | 2021-01-06 | feeling abnormal |
12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went awa...
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12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.
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| 60 | 2021-01-07 | mental impairment, anxiety |
Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD...
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Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.
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| 60 | 2021-01-08 | impaired work ability | Headache very fatigue, soreness at injection site Narrative: stayed home from work |
| 60 | 2021-01-10 | feeling abnormal |
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache...
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Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 60 | 2021-01-10 | impaired work ability |
Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and ...
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Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
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| 60 | 2021-01-10 | sleep disorder |
four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and incre...
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four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls
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| 60 | 2021-01-11 | anxiety | Dizzy and very anxious |
| 60 | 2021-01-11 | feeling abnormal |
Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point;...
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Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.
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| 60 | 2021-01-11 | impaired work ability |
developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report ...
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developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report to work the following day, symptoms then resolved.
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| 60 | 2021-01-14 | anxiety |
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,...
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Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
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| 60 | 2021-01-14 | feeling abnormal |
reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports wea...
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reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,
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| 60 | 2021-01-15 | insomnia, excessive sleepiness, sleep disorder |
Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thy...
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Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.
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| 60 | 2021-01-17 | restlessness | itching all over, restlessness, patient allergic to benadryl. |
| 60 | 2021-01-18 | feeling abnormal, disturbance in attention |
Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and fo...
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Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening
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| 60 | 2021-01-18 | feeling abnormal |
Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupil...
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Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.
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| 60 | 2021-01-18 | excessive sleepiness |
Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Head...
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Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.
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| 60 | 2021-01-18 | nervousness |
WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE M...
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WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH
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| 60 | 2021-01-19 | nervousness |
Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS ...
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Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours
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| 60 | 2021-01-20 | feeling abnormal, memory impairment |
Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up i...
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Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.
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| 60 | 2021-01-21 | feeling abnormal, memory impairment |
Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complet...
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Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.
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| 60 | 2021-01-24 | feeling abnormal, impaired work ability |
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate...
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Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-25 | confusional state, memory impairment, disturbance in attention |
Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentra...
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Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
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| 60 | 2021-01-25 | feeling abnormal |
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz...
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Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
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| 60 | 2021-01-26 | insomnia |
allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath...
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allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-01-26 | sleep disorder |
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ...
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First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
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| 60 | 2021-01-27 | sleep disorder |
Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritat...
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Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.
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| 60 | 2021-02-01 | anxiety |
pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than...
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pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than normal but subsided after about 2 hours. She was about to go to the ER but waited a little longer since she thought she was just having anxiety issues and did not have to go. She will contact her PCP today to let them know and discuss getting the second dose.
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| 60 | 2021-02-01 | feeling abnormal |
Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with gene...
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Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.
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| 60 | 2021-02-01 | feeling abnormal |
Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min lat...
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Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min later) Wed 1/27/21 5am fever, aches, chills, foggy, slight headache, exhausted. Wed 1/27/21 7pm exhausted, foggy Thurs 1/28/21 5am exhausted, foggy, no reserve Fri 1/29/21 5am tired, foggy Sat 1/30/21 Much better.
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| 60 | 2021-02-02 | anxiety, feeling abnormal | Pt reports feeling "out of body", lightheaded, impending doom, nauseated and diaphoretic. |
| 60 | 2021-02-02 | confusional state, mental impairment |
Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to c...
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Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!
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| 60 | 2021-02-03 | feeling abnormal |
slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupil...
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slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.
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| 60 | 2021-02-03 | impaired work ability |
I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I st...
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I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.
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| 60 | 2021-02-03 | impaired work ability |
I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I to...
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I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I took a Tramadol, got an ice pack, placed it on my head and put some lavender on my pillow, called into work and went back to bed. I still have the headache and fatigue, but I am able to work so far.
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| 60 | 2021-02-04 | anxiety |
At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her l...
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At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm. There was a small area that had a lace modeling appearance. Patient denied any pain or itchiness to this area and there were no hives. Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand. She was offered Benadryl from the clinic but refused and really wanted to take her own. Approval from supervisor obtained and Benadryl was verified. VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm. Patient denied any other signs and symptoms of allergic reaction except anxiety. VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%. No change in condition and patient felt good enough to leave. Patients sister accompanied her to the clinic today and will stay with her tonight.
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| 60 | 2021-02-04 | disorientation, sleep disorder |
1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that da...
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1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'
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| 60 | 2021-02-04 | feeling abnormal |
12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache o...
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12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.
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| 60 | 2021-02-06 | feeling abnormal, impaired work ability |
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ...
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High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
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| 60 | 2021-02-07 | sleep disorder |
Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrica...
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Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.
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| 60 | 2021-02-08 | anxiety, sensation of foreign body |
The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and g...
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The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED
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| 60 | 2021-02-09 | anxiety |
Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response...
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Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response within 5 minutes. No Treatment or Transport.
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| 60 | 2021-02-14 | feeling abnormal, confusional state |
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE...
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2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
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| 60 | 2021-02-14 | loss of personal independence in daily activities |
About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, j...
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About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin. About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.
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| 60 | 2021-02-14 | loss of personal independence in daily activities |
shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakn...
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shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.
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| 60 | 2021-02-15 | anxiety, insomnia |
1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 late...
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1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 later. Insomnia. *still experiencing insomnia and anxiety
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| 60 | 2021-02-15 | feeling abnormal |
Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started ...
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Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.
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| 60 | 2021-02-15 | feeling abnormal |
Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , head...
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Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.
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| 60 | 2021-02-15 | insomnia |
12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minu...
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12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.
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| 60 | 2021-02-16 | confusional state |
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for...
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Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.
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| 60 | 2021-02-16 | sleep disorder, impaired work ability |
Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued thr...
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Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued through the night. I could not sleep. In the morning (9:00) I tried to sleep but had very bad chills for over an hour. Went down to couch and covered up with many blankets. Chills continued for 4-5 hours. Also experienced tiredness, and general 'feeling unwell' throughout the day, as well as extreme heartburn. I stayed home from work and sat on the couch all day, feeling unwell. By about 8pm all of the symptoms disappeared.
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| 60 | 2021-02-17 | feeling abnormal |
This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the sec...
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This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.
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| 60 | 2021-02-20 | sleep disorder |
Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injecti...
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Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.
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| 60 | 2021-02-24 | anxiety |
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details:...
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins
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| 60 | 2021-02-27 | impaired work ability |
slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss o...
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slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.
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| 60 | 2021-03-01 | disturbance in attention |
At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes ...
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At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes like before with the first vaccine. The muscles of my eyes and eye lids feel weak and difficult to focus. I started having extreme nausea and could not go to work. No appetite either. I now have Oscillopsia and feel sick.
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| 60 | 2021-03-04 | confusional state |
Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to ...
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Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"
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| 60 | 2021-03-04 | nervousness |
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev...
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COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
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| 60 | 2021-03-06 | sleep disorder |
Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the d...
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Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the day progressed the pain increased substantially into my shoulder. It then started to hurt on the left side of my neck. I took Tylenol before bed, 500 mg is all I can take. This pain kept me awake all night and this morning I am not able to lift my arm up or down or sideways without pain, quite a bit of pain. Today is Sunday and I do not plan to seek medical care unless it continues to worsen. I will probably talk with my medical provider tomorrow if this continues.
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| 60 | 2021-03-07 | feeling abnormal |
I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and ...
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I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.
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| 60 | 2021-03-07 | mental impairment, sleep disorder |
Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in ...
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Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in all bones of body - face bones, leg and arm bones, ribs, etc. Thinking became foggy - everything became difficult to do. I went to bed at 7:30 pm on 2/25/2021 - slept fitfully until 6:30 am on 2/26/2021. All symptoms had lessened by 30%-50% during the day on 2/26/2021. By 2/27/2021, I felt pretty much like me again.
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| 60 | 2021-03-08 | disturbance in attention |
Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent ca...
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Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent care.
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| 60 | 2021-03-08 | feeling abnormal | fever, chills, back pain, fatigue, loss of appetite, foggy |
| 60 | 2021-03-08 | feeling abnormal | Low-grade fever, chills, body weakness, aches, brain fog, fatigue |
| 60 | 2021-03-09 | impaired work ability |
Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with d...
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Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.
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| 60 | 2021-03-09 | insomnia |
On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3...
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On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.
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| 60 | 2021-03-10 | anxiety | heart racing, anxious. Evaluated by EMS-Cleared |
| 60 | 2021-03-10 | sleep disorder, anxiety |
1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself ...
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1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself having trouble breathing while dreaming. I sat up, elevated, and went back to sleep. SOB that afternoon. I slept and woke up the next day and felt fine, went to work. 1/14 I worked all day. 3:10 I couldn't breath. Was with my neurologist. Pulsox was 79. I went to the ER. Hooked me up to IV, chest xray. Dr. said anxiety was up. After 4.5 hours I was able to go home. symptoms subsided.
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| 60 | 2021-03-11 | disorientation |
Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started aro...
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Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
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| 60 | 2021-03-13 | sleep disorder |
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:...
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2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
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| 60 | 2021-03-15 | anxiety |
After receiving her vaccine, client stated she felt lightheaded and anxious. Vital signs obtained b...
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After receiving her vaccine, client stated she felt lightheaded and anxious. Vital signs obtained by EMS BP 177/106, HR 83, O2 sat 99%. Client stated she feels better. Client discharged home.
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| 60 | 2021-03-15 | feeling abnormal |
Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt t...
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Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.
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| 60 | 2021-03-15 | impaired work ability |
experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and bo...
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experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s
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| 60 | 2021-03-16 | anxiety |
Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earli...
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Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.
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| 60 | 2021-03-16 | anxiety | Felt anxious, with chills/tingling in feet. BPs 174/77 (pulse 71), O2 sat 98%. Final BP 134/75. |
| 60 | 2021-03-16 | feeling abnormal, loss of personal independence in daily activities |
Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick ...
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Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.
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| 60 | 2021-03-18 | anxiety | Heart palpitations, anxiety,(felt this prior to today). 126/84, 87, 6, 99%, BGL 176 |
| 60 | 2021-03-18 | feeling abnormal |
Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pa...
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Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-18 | loss of personal independence in daily activities |
Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very ...
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Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore. The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and the arm is swollen/inflammed. Uncomfortable for daily activities like typing or eating. Does respond to ibuprophen. Trying to rest it and have it in sling to rest it.
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| 60 | 2021-03-19 | feeling abnormal, confusional state |
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, ...
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Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
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| 60 | 2021-03-19 | impaired work ability |
Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; f...
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Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; fatigue is so severe that I have had to stop working. I am a physician doing telemedicine
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| 60 | 2021-03-19 | sleep disorder |
Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both...
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Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both feet and both lower legs mainly at night. Difficulty sleeping. This continued each night but during day of Friday, Mar 19, 2021 the neuropathy continued and the numbness and tingling migrated up into my legs and into my arms and hands but not as intense as in my feet and lower legs Tingling, shakiness felt in muscles is continuous now, not just at night. I was scheduled to have 2nd dose today but decided not to go through with getting it. Consulted with my APRN on phone and they advised to get 2nd dose and we would follow up if needed on neuropathy. I decided I did not want the 2nd dose.
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| 60 | 2021-03-21 | impaired work ability |
03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD...
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03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.
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| 60 | 2021-03-21 | nervousness, feeling abnormal |
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl...
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8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
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| 60 | 2021-03-22 | anxiety |
Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk t...
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Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk to the bathroom and made aware that we needed her to be stable before getting up again. Patient took a 5 minute rest and felt better. Patient guided to the bathroom but once she came out of the bathroom she became dizzy again. Patient was provided with a chair again but started to become frantic so we provided her with a cot and laid her down but patient started to become very short of breathe. Medics called and provided with hand off.
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| 60 | 2021-03-22 | anxiety | woke up with severe vertigo. Then had an anxiety attack. |
| 60 | 2021-03-22 | loss of personal independence in daily activities |
March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily function...
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March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily functions. Reporting app did not ask about that date and I want to report that was a bad day. I did not seek medical treatment. Treated with ibuprofen and rest
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| 60 | 2021-03-22 | loss of personal independence in daily activities |
Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a pla...
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Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache
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| 60 | 2021-03-22 | sleep disorder |
I could actually feel the vaccine entering my blood stream above and below injection area. I had sh...
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I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.
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| 60 | 2021-03-23 | feeling abnormal |
Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advi...
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Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.
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| 60 | 2021-03-23 | feeling abnormal |
Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced...
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Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.
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| 60 | 2021-03-23 | feeling abnormal |
Began to feel bad one week after receiving injection and made appt with provider, xray showed infi...
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Began to feel bad one week after receiving injection and made appt with provider, xray showed infiltrate, pnuemonia, in right lower lobe, antibiotics prescribed and taken increased shortness of breath at time of visit.
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| 60 | 2021-03-23 | sleep disorder, loss of personal independence in daily activities |
The injection was in the shoulder. Pain began less than one day later. I waited for the pain to re...
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The injection was in the shoulder. Pain began less than one day later. I waited for the pain to resolve. It has not. My shoulder is still sore. The pain is getting progressively worse and it now hurts to comb my hair, it hurts to raise my arm to put dishes in the cabinet, and it is hard to carry lift and carry objects of 8 ounces more. This pain also make it difficult to sleep through the night.
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| 60 | 2021-03-24 | thinking abnormal | Mania and hyperactivity and fragmented thinking. Pressured speech |
| 60 | 2021-03-25 | hallucination | Hallucinations Possibly fever, fatigue & dehydration 1-2 days ago Mild headache |
| 60 | 2021-03-25 | impaired work ability |
Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 3...
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Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.
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| 60 | 2021-03-26 | sleep disorder |
Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and s...
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Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha Day 4..... headache, cough diarreha
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| 60 | 2021-03-27 | confusional state |
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness...
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Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
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| 60 | 2021-03-28 | anxiety | BP 153/89, HR 84,O2 100%, 12 lead normal. Anxiety, weakness, palpitations. Exit time 11:22 am. |
| 60 | 2021-03-30 | anxiety |
pt. reported hx of anxiety and forgot to take medication. BP 152/84. HR-WNL. pt. now wants her BP ...
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pt. reported hx of anxiety and forgot to take medication. BP 152/84. HR-WNL. pt. now wants her BP checked. No interventions other than reassurance. pt. verbalized understanding to call 911 for any assistance after leaving clinic.
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| 60 | 2021-03-31 | anxiety |
Feels dizzy but thinks it may be anxiety. No other signs or symptoms. Informed to seek medical adv...
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Feels dizzy but thinks it may be anxiety. No other signs or symptoms. Informed to seek medical advice if any further problems.
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| 60 | 2021-04-02 | anxiety | After 30 minutes , Pt C/O throat dryness, cough, SOB nausea and anxiety |
| 60 | 2021-04-02 | feeling abnormal |
I'm fairly certain that the vaccine caused a severe fibromyalgia flare-up, about 3 days after gettin...
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I'm fairly certain that the vaccine caused a severe fibromyalgia flare-up, about 3 days after getting the vaccine. This flare-up has been much more severe than the ones I usually get. The pain, fatigue, and brain fog has been extreme. No fever or flu-like symptoms.
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| 60 | 2021-04-03 | feeling abnormal, irritability |
my body is killing me; body pains; fever/Had a 101 fever at night; experienced ulcer on the side of ...
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my body is killing me; body pains; fever/Had a 101 fever at night; experienced ulcer on the side of her tongue; eye stye/I started with some kind of infection like stye something; felt terrible/ I am just feeling bad/Started freaking out; Swollen eyes/more puffy; irritable; stressed/Shot stressed my body; headache; Drug sensitivity/Reaction to medicine; I didn't have a taste; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection, Lot number: EN6204; Expiration Date: 30Jun2021), via an unspecified route of administration, in the left arm on 12Mar2021 around 1:15- 01:20 PM (at the age of 60-years-old) as 0.3 mL, single for covid-19 immunisation. Medical history included arthritis, anxiety and I had the virus in November. Concomitant medications included meloxicam (MOBIC) taken for arthritis as needed; alprazolam (XANAX) at 1 mg daily for anxiety. On an unspecified date in Mar2021, the patient had body pains, had a 101 fever at night, headache, ulcer on tongue, swollen eyes, stye in eye, felt terrible/started freaking out, irritable, drug sensitivity/reaction to medicine, shot stressed my body. Consumer stated, I had gotten the vaccine the other day, Friday. You don't know me but if you know me, I am going to have the side effects and it's going to happen, and it happened. From the next day my body is killing me. I had a 101 fever at night, felt terrible. Anyway, the next day, I felt better, whatever. And then yesterday, I felt pretty good except I started with all of a sudden, I got ulcer on my tongue. Now, I have got like, I don't know a stye happening on my eye and I know, it's all due to that vaccine because I have reactions to the medicines. I got to watch what I do. And I was scared to get this thing anyway, I already didn't want to get the shot and I did it. But anyway, right now, I am just feeling bad because of my tongue and I kind of looked up that and it did say that it can be caused from like a drug sensitivity. I do know it's all because of that." Consumer further stated, "Like 3 days later, I started with some kind of infection like stye something on my eye. Yesterday it started, and also, I have an ulcer on my tongue now. But I guess what I am afraid of, in less than 3 weeks, I have got to take this vaccine again. The patient had the virus in November, and I did test positive at some point for the antibodies and when I looked up something, as I was running a high fever. I started looking up stuff and it said if you already have a pre-existing immunity which I did due to the antibodies. I believe it's still there because it has been 4 months, but you might get. It says you will get side effects worse; you will get side effects. People that have never got exposed and have antibodies, don't get the side effects but I got them. So, I guess what I am afraid of because now I am like, I know it's a reaction to the medicine. And now I got ulcers on my tongue. And my eye, yesterday it started with the stye thing, and I never get them, it was swollen. I know this was a reaction from that vaccine, I know it was. I don't have fever and none of that no more, the body aches have left me. It was pretty bad, but it left me. But I am scared to get that next vaccine. Consumer stated, my 'eye' also started getting kind of sore and now it's swollen and I know this was a reaction to that because my body did not like that's all I can tell you. I am afraid if I get the next vaccine which was on 02Apr2021 (later confirmed), am I going to get, I am scared that something worse is going to happen to me. Because everybody knows if you had the vaccine, any of them, nobody and they say with the first vaccine usually you don't get anything, it's the second one. Well, I know, it was going to happen to me, and it did happen to me. So, I am scared what's going to happen with the second one. If my body still has antibodies from the virus, it did say or I read, maybe it's not true but what I read, it said 89 or 87% people that have already been having pre-existing immunity which would be me because I had the antibodies, you won't get the side effects more than people that never had the antibodies or had the virus. I didn't have a taste because I was having a high fever initially when I had the virus. It was weird. I cannot explain the feeling. I was laying down that night, that Saturday night, I thought let me check my temperature and it was like 99.5 and then maybe an hour later 100 and at 1:30 in the morning, it was 101 and then a couple of hours later, I checked it and it was like down to 100.5. I was calling a Pharmacist when I started freaking out on that. And they said no, nothing was going to happen. On Sunday morning, it was 99.5 and then when I checked it yesterday, I had nothing, no more fever. But then I started with ulcer and I looked it online and it said that it could be due to the stress and I was very stressed out because of getting a shot. I didn't want to do it and I did it but one of the things, it said a sensitivity to foods and drugs can cause ulcers in the mouth and I know it was that and then my eye, I don't know about the eye, it's swollen underneath. I know this was a reaction, I know it was. Eye was a little worse. I guarantee you, it's due to the shot. Shot stressed my body. That was just my reaction to that shot because it started all the side effects. And then 3 days later, it started with an ulcer in eye. And I guess that it's just too coincidental. It just stressed my body bottom line. The eye was a little bit worse today. The ulcer was going to go away, but it is at its peak right now. I am worried about the eye. It started sore yesterday and then today it is more puffy and I kind of put my contact lenses on it. It's not in the eye. It's on the tissue of bottom lid near the edge of the eye. The patient underwent lab tests and procedures which included blood test which showed okay, everything was okay. Therapeutic measures were taken as a result of ulcer on the tongue included had a mouth wash that she used and had done great to my teeth. The ulcers are going to go away, but the eye was. I am just kind of watching it if it gets like whatever tomorrow. I might go to emergency room. It's not in the eye. It's in the lower lid. It's very tender and close to eye." Consumer further stated, "I want to know an answer. This is really important to me because this time, I have to take a nerve because as soon as they put the needle in me, my nerves, I just had a panic attack. I was scared. I need to know do I need to afraid to get next vaccine because I won't do it if I knew something worse going to happen, I won't do it. I already have the reaction, but I don't want to risk our lives again. I got the side effects. Consumer stated, I'm a little sensitive to the medicines. I keep a check on what do I take. The outcome of the events body pains and fever recovered on Mar2021, ulcer on the side of her tongue, felt terrible/ I am just feeling bad/started freaking out was recovering, swollen eyes/more puffy; eye stye/I started with some kind of infection like stye something; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye was not recovered and other events was unknown. Causality assessment for events had a 101 fever at night, ulcer on tongue, swollen eyes with BNT162B2 was related per reporter.
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| 60 | 2021-04-04 | impaired work ability |
She got the vaccine, only had the real sore arm. She went to bed and trying to get ready to go to w...
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She got the vaccine, only had the real sore arm. She went to bed and trying to get ready to go to work, had a slight fever, headache, chills, aches, stomach didn't feel right. Felt like she had the virus again. She was in bed all day on Friday, and then that night she still had chills and 101.1 fever. Did not feel well on Saturday and was out of work for 2 days. She is feeling better, tired. The arm is still sore to touch, but not as bad. She just felt sick, and is feeling better today. Her stomach is still not right, but overall feeling better. She did take Tylenol which helped and a couple of other times for the symptoms.
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| 60 | 2021-04-04 | restlessness |
Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachach...
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Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.
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| 60 | 2021-04-05 | feeling abnormal |
TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER S...
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TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER SHOT LASTING ABOUT 4 HOURS..THEN TONGUE AND FACE FELT TINGLING ..TONGUE FELT SWOLLEN METAL TASTE IN MOUTH AND A VERY FUZZY FEELING FOR THE DAY OF AND DAY AFTER SHOT WENT TO WALK IN CLINIC AT 620 PM ON 4/3. RECOMMENDED BENEDRYL RATHER THAN STEROID METAL TASTE AND FEELING OF SWOLLEN TONGUE SUBSIDING....FACE TINGLE REMAINS ON 4/6/21
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| 60 | 2021-04-06 | insomnia |
rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontan...
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rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.
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| 60 | 2021-04-07 | mental impairment |
March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (contin...
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March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.
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| 60 | 2021-04-07 | mental status changes, hallucination |
shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital ...
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shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2
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| 60 | 2021-04-08 | nervousness, anxiety |
Numbness and tingling of tongue and lips. Patient reports she felt and still feels nervous and anxi...
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Numbness and tingling of tongue and lips. Patient reports she felt and still feels nervous and anxious about COVID vaccine. Vitals when arrived at meds observation at 11:09 am, HR96, resp 18, BP 183/89, 98% SaO2. BY 11:11 resolving numbness and tingling of mouth. Vitals at 11:12am, HR 95, Resp 18, BP 171/85, 98% SaO2. At 11:20 am, patient reports only slight numbness and tingling in tongue, lips resolved. Vitals at 11:20, HR 94, Resp 18, BP 165/80, SaO2 98%. Patient came back from bathroom( assisted to & from bathroom by med obs RN), vitkas when back at 11:33 Hr81, resp 18, BP 194/82, SaO2 100%. Rechecked vitals 11:39, Hr 88, Resp 18, BP 180/80, SaO2 97%. Vitals at 11:56 am, patient reports most of tongue tingling is gone, Vitas at 11:56, HR84, Resp 18, BP 174/87 , SaO2 98%. Vitals at 11:49, HR 93, Resp 18, BP 164/83, SaO2 97%. Patient anxious and wants to leave. Vitals at 12:05, HR 86, resp 16, BP 184/84, SaO2 97%. Spoke with provider about patient's situation. Okay for patient to leave since being worked up by PCP for HTN. Patient instructed to check BP once she got home (has been monitoring BPS at home due to HTN) and notify PCP about BPs while here. Patient's vitals at time of leaving via own personal vehicle, HR 90, Resp 16, BP 183/83, SaO2 98%. Patient reported only a little tingling in tongue when she left.
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| 60 | 2021-04-08 | nervousness |
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys...
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Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 60 | 2021-04-09 | feeling abnormal |
around 1106am patient complained of "harsh" throat and "just not feeling right" EMS on scene perform...
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around 1106am patient complained of "harsh" throat and "just not feeling right" EMS on scene performed EKG 11:10am patient had emesis, 118/72, HR-76, 98% on room air, PA evaluated pt on site and ordered Hydroxyzine 25mg po x1. pt took this and has no complaints.
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| 60 | 2021-04-10 | agitation |
Almost immediately felt flushy and a bit hyper and then started to develop numbness (not pins and n...
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Almost immediately felt flushy and a bit hyper and then started to develop numbness (not pins and needles) of the front of my face. Somewhat milder than for the first dose, both of my upper arms started to feel discomfort within a few minutes. The numbness dissipated within an hour and a half, by which time I started to feel achy and have some of the common side effects. Next day was very achy and did not have much stamina. Was feeling much better in the morning of 04/11/2021. In the evening of 04/11/2021 started to feel some numbness in my nose again.
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| 60 | 2021-04-10 | hallucination, restlessness, insomnia |
Mild to moderate hallucinations for about 10 hours, starting about 6 hours after vaccine. insomnia ...
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Mild to moderate hallucinations for about 10 hours, starting about 6 hours after vaccine. insomnia & restlessness - at its worst during first 24 hours, then tapering off in severity but continuing for 48 hours. Both were tolerable but uncomfortable. These were very unusual symptoms that were not listed as expected symptoms so I thought they should be reported.
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| 60 | 2021-04-11 | anxiety |
9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. B...
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9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. BP 151/86 HR 75 RR14 Sat 98% 0.9 % NSS to keep vein open Benadryl 50 mg IV one dose stat
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| 60 | 2021-04-11 | feeling abnormal, loss of personal independence in daily activities, impaired work ability, sleep disorder |
My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very ...
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My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very swollen, hard, and painful enough to wake me in the middle of the night. The hard lump was as big & wide as my right hand and began 2 inches above my elbow up to the place of injection. When my morning alarm went off, I was very fuzzy and extremely weak. I was unable to go to work or remember a lock combination I use every day. My energy began to return the next day enough to work a half day but returned to bed for the afternoon. The tiredness was all but gone by 8:30 pm. Reaction began Sunday morning and was gone by Tuesday night.
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| 60 | 2021-04-11 | sleep disorder |
Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my ba...
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Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.
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| 60 | 2021-04-12 | amnesia, memory impairment, feeling abnormal |
Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my lef...
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Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my left eye with filled with blood over most of the sclera. Severe joint pain. Muscle pain, and lethargy. Extremely forgetful with new onset 04/07/2021. Eye pain left eye. L eye hemorrhage is not resolved yet.
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| 60 | 2021-04-12 | anxiety |
pt states after receiving vaccine about one minute after pt states she felt arm tingling and pins an...
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pt states after receiving vaccine about one minute after pt states she felt arm tingling and pins and needles feeling in left arm and metallic taste in mouth, and very anxious pt shaking and was unable to sit still in stretcher, refused wheelchair to observation area and ambulated self without difficutly. pt also very guarded and did not want to talk about health history or meds upon assessment. pt state feeling hot and cold chills as well. pt anxious about previous anaphylaxis had in past with darvocet. denies feeling symtpoms of anaphylaxis, site of injection healthy no observed hives or redness in area. vs as noted, pt feeling better and wanting to be sent home pt ambulated to exit with husband at 1438 vs: 1410 bp123/81 hr 84 rr 18 o2 97 1415 bp 140/96 rr 18 hr 78 o2 98 1420 bp 137/80 hr 80 rr 18 o298 1425 131/89 hr 80 rr 18 o2 99
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| 60 | 2021-04-12 | anxiety |
Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Ben...
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Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Benadryl 25mg given by mouth
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| 60 | 2021-04-12 | feeling abnormal, loss of personal independence in daily activities |
very bad migraine, nausea, chills, overall very sick feeling, could not get out of bed Took migraine...
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very bad migraine, nausea, chills, overall very sick feeling, could not get out of bed Took migraine meds & some Tylenol, did not help to counter symptoms and migraine The entire day, starting at 4am, I was unable to get out of bed For the past 1 1/2 weeks I feel very run down and my brain is foggy Will not take a booster vaccine ever! These entire after effects are not worth the taking the vaccine.
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| 60 | 2021-04-12 | feeling abnormal |
I have suffered from tinnitus for a very long time but about a week after receiving the vaccine I wo...
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I have suffered from tinnitus for a very long time but about a week after receiving the vaccine I woke up to a ramped up ringing in my ears that has not subsided. The noise level increased at minimum 50% and it causes brain fogginess I have not previously experienced.
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| 60 | 2021-04-13 | feeling abnormal |
04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER87...
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04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together
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| 60 | 2021-04-14 | excessive sleepiness |
Slight headache, fever (100.4), reduced appetite. It felt like a mild case of the flu. I was allow...
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Slight headache, fever (100.4), reduced appetite. It felt like a mild case of the flu. I was allowed to leave work and go home. I slept for a few hours, ate a little bit and went to bed very early (8:45pm). By the next morning, the fever broke and I was fine.
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| 60 | 2021-04-15 | sleep disorder, feeling abnormal |
Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could n...
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Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could not sleep all night because bones started to ache terribly...felt like my bones were going to explode, which seemed like a very unusual reaction. Halfway through the night, got nauseous. Later in the night got stuffed nose and headache. Woke with headache, body aches, fuzzy head and had fever up to 101.5 all day. Took a Tylenol in the morning and drank a cup of coffee and lots of water which made headache disappear. Finally took a Motrin at 6pm and started feeling much better by 9pm. Slept well. By 7am next morning, was 100% fine albeit tired.
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| 60 | 2021-04-16 | anxiety | Nausea vomiting throughout the day and continuous the next night, sense on impending doom |
| 60 | 2021-04-16 | anxiety | Pt c/o anxious and claustrophobic, & nausea. "I just want to get out of here, I want to go outside." |
| 60 | 2021-04-16 | insomnia |
experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swo...
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experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.
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| 60 | 2021-04-17 | impaired work ability |
Patient received Pfizer for her first dose on 3/17/21 and a moderna for her second dose on 4/8/21. S...
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Patient received Pfizer for her first dose on 3/17/21 and a moderna for her second dose on 4/8/21. She states at the 24 hour mark of receiving the moderna she experienced extreme joint pain and swelling. She states she has not been able to work when I called to check on her on 4/13/21.
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| 60 | 2021-04-18 | feeling abnormal |
Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and...
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Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and feeling of weakness and foggy head day after injection 41/18/21 subsided by third morning 4/19/21.
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| 60 | 2021-04-18 | impaired work ability |
Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getti...
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Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getting worse into Wednesday evening to where I was having trouble moving my arm up down behind me a crossed my midsection and out away from my side, pain getting worse intoThursday morning. Called off work Thursday/Friday. Other symptoms subsided after 48 hrs but not the pain in Site area and shoulder. Saturday not improving went to clinic in afternoon.
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| 60 | 2021-04-18 | sleep disorder |
Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine wit...
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Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort
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| 60 | 2021-04-19 | feeling abnormal |
Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk acr...
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Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner
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| 60 | 2021-04-19 | feeling abnormal |
Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hu...
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Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hurt. Went to bed about 10. Woke up about 1:30/2:00 with left arm hurt a lot. Took Advil and went back to bed. Woke up at 4 am to get ready for work and felt awful. Noticed was out of breath on short horizontal walk from bedroom to bathroom, chest tight, acting like an asthma attack. Took a puff of albuterol inhaler and went back to sleep. Got up just before 7, still sore to breath. Grabbed oximeter (being asthmatic, I have one) and noticed )s level down to 94/95 when normally it reads 98/99 on this one. Called allergist to cancel allergy shot scheduled for that morning. Took another puff of albuterol. (Waiting to see if need nebulizer.) Breathing becoming easier and reading now about 97/98 with pulse lower, more normal. Lungs a bit touchy this time of year anyway. And I have had allergic reactions in the past take place as an asthma attack. (For instance, if I eat a small quantity of something with yellow dye 5 in it, I will notice that my breathing is more difficult.)
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| 60 | 2021-04-19 | sleep disorder |
Tinnitus in both ears, noted the morning after second dose and fairly constant since then (4 days). ...
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Tinnitus in both ears, noted the morning after second dose and fairly constant since then (4 days). Loud enough to interfere with sleep at night. I hope it goes away!
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| 60 | 2021-04-20 | delirium |
DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIR...
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DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION
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| 60 | 2021-04-20 | feeling abnormal |
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ...
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her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 60 | 2021-04-20 | sleep disorder |
The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. N...
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The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. Night-time ... difficult to sleep. Next morning (today) very painful ... difficult to stand (at times) and sit. All similar to my back condition in December that I thought was under control. Taking over the counter medications haven't helped yet. Alternating heat / ice / bacx-brace.
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| 60 | 2021-04-21 | insomnia | Tiredness, insomnia, achy, headache; aspirin and rest |
| 60 | 2021-04-21 | loss of personal independence in daily activities |
On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the ni...
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On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.
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| 60 | 2021-04-21 | nervousness |
15 minutes after vaccine, I felt a sudden burning, warm feeling spread through my arms and head. I c...
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15 minutes after vaccine, I felt a sudden burning, warm feeling spread through my arms and head. I checked my Watch and heart rate was 127. I had a similar reaction with the first shot on 3/24/21 and was told by staff that it was probably due to hyperventilation and panic after they took my vitals. I did not seek medical attention the second time as the burning sensation disappeared quickly and I was able to lower my heart rate through breathing exercises. I left the medical location about 15-20 minutes after the episode and drove home without incident. I had moderate arm pain and fatigue the rest of the day. On the morning of 4/22/2021, I woke up feeling well except arm pain. At around 7:45 that morning, I had a sudden shaky episode where my watch registered heartrates from 105 up through 153. My hands tingled and they developed a significant tremor. These symptoms are typical for me during a panic attack. I took 1/2 of a Clonazepam and did some breathing exercise and was able to get my heart rate back to normal (in the 70s) within 10 or 15 minutes.
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| 60 | 2021-04-22 | sleep disorder |
Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe ...
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Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe than normal heartburn, little burning in chest and gallbladder pain. not sleeping well because of it
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| 60 | 2021-04-23 | confusional state |
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Additi...
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Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Additional Details: patient said a few days after 1st vaccine she had flu like symptoms: fatigue,brain fog,headache and has not gotten better,also depression,loss of interest in doing things
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| 60 | 2021-04-24 | feeling abnormal, nervousness, sensation of foreign body |
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc...
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Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown. Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 60 | 2021-04-25 | feeling abnormal | Sore arm High fever 103 Foggy brain Fatigue Aches |
| 60 | 2021-04-25 | sleep disorder |
Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm o...
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Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm on a Monday. Within a few hours, this spread to my entire body; every joint and muscle was in severe pain and discomfort. I went to bed around 5 pm and had the chills, but no fever. I continued with this pain for Monday night and could barely sleep. It continued but not as severe on Tuesday and Wednesday. By Thursday, I forced myself to take a shower. By Thursday, the pain in the upper body was gone, but I still had severe pain in both lower legs from the knees down. It was unbearable if I stood for more than 20 seconds, however, if I lifted each leg and then alternated legs, the pain would go away. This felt like enormous pressure in my legs and at one point, I thought maybe I had blood clots, but my legs were not red or swollen. The lower leg pressure finally went away on its own by Sunday, April 25th, 2021. At no point did I have a fever and I could get some relief by taking Ibuprofen, but not a lot of relief.
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| 60 | 2021-04-26 | disturbance in attention, disorientation |
her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional ...
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her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.
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| 60 | 2021-04-26 | feeling abnormal |
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem...
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This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
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| 60 | 2021-04-27 | agitation, confusional state |
Extremely confused and agitated. Vision was reduced significantly. Not able to understand or compr...
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Extremely confused and agitated. Vision was reduced significantly. Not able to understand or comprehend simple tasks. This went on for 3 days.
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| 60 | 2021-04-27 | delirium |
delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable c...
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delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 10:00 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose on 23Mar2021 at 10:00. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at 22:00, about 12 hours after receiving the 2nd dose, the patient experienced chills, fever, delirium, headache, and body aches. By 35 hours after the dose, symptoms were mostly past. The patient did not have COVID prior vaccination and patient was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 60 | 2021-04-27 | insomnia | Muscle aches, fever, sleeplessness, fatigue |
| 60 | 2021-04-29 | anxiety |
Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Pe...
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Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Personnel. Cardiopulmonary Resuscitation was initiated. Pt was very anxious when EMS arrived.
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| 60 | 2021-04-30 | feeling abnormal |
Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Diz...
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Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-04-30 | sleep disorder |
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,...
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anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
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| 60 | 2021-05-18 | mental status changes |
Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfize...
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Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfizer. Patient has known COVID19 exposure from her son and was COVID19 positive in April. The patient had a positive asymptomatic COVID-19 test. Patient was tested prior to planned colonoscopy. The patient completed 10 days of quarantine until April 22. Patient presented to hospital (sister hospital) on May 2nd after 1 week of fevers and productive cough. At MSQ patient received cefepime/vancomycin/doxycycline for CAP. She initially improved, but on 5/5 she had recurrent fever with rapid decline, her respiratory status requiring 2L of NC to HFNC to NRB. CXR with B/L opacifications. CTA chest was negative for PE, but patient with diffuse groundglass and consolidative opacities. Also had TTE that showed LVEF 71% and grade 1 diastolic dysfunction. She was evaluated by MSQ Infectious Diseases physician and was started on bactrim for PCP prophylaxis and resumed on broad spectrum antibiotics. She was also evaluated by rheum in sitting of her SLE and patient was started on prednisone 40 mg q8h methylprednisolone for potential SLE flare. Continued on cefepime and vancomycin. Patient was transferred to Hospital due to worsening respiratory status and tested positive for COVID-19 at MSH on 5/9. Admitted to the MICU, patient received a loading dose and one 100 mg dose of remdesivir - stopped due to elevated liver enzymes. On 5/16 extensive new ischemic/hemorrhagic strokes throughout intracranial vascular distribution, DIC d/t COVID vs AF and intubated for mental status changes. Patient's clinical picture worsening - requiring pressors. Chest x-ray with diffuse ground glass opacities, ARDs and pulmonary edema. Patient remains in critical condition in MICU as of 5/19.
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| 60 | 2021-05-25 | disturbance in attention, anxiety |
incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her brea...
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incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.
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| 60 | 2021-05-25 | feeling abnormal |
An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone o...
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An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone on the left side, a lot of heart burn or air bubbles in my chest also, and now I'm scared to get the 2nd dose and I've not felt right since.
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| 60 | 2021-05-27 | loss of personal independence in daily activities |
At 6:00 a.m. on May 23, 2022, the 9th day after my 2nd dose of the Pfizer COVID-19 vaccine I stood ...
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At 6:00 a.m. on May 23, 2022, the 9th day after my 2nd dose of the Pfizer COVID-19 vaccine I stood up and became so dizzy I feel head-first into a chair next to the place I was standing. Since that time I have experienced extreme vertigo (for the first time in my entire life I have never been dizzy in my life, at all). I can?t lay on my left side because I can?t turn my head to the left. I can?t drive because I can?t turn my head to the left. When I do, my head becomes swimmingly dizzy. It is an extreme dizziness. Not just lightheaded. Also I cannot lean my head backward to look up because I experience the same thing. I have joined a website for COVID-19 Vertigo side effects in order to get information or ideas as to what I can do and when I can hope for relief.
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| 60 | 2021-05-28 | confusional state |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild
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| 60 | 2021-05-28 | impaired work ability |
Vaccine given in the afternoon of 1/16, a Saturday. By Sunday am on the 17th, the hearing was gone ...
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Vaccine given in the afternoon of 1/16, a Saturday. By Sunday am on the 17th, the hearing was gone in my right ear. Got into the ENT doctor on Monday the 18th. Had an exam and hearing test. Started high dose of steroids on 1/19. Had to be out of work for 1 month. About 80% ish of the hearing returned in that ear. Had 1 steroid injection into ear drum of that ear. Throughout the month, had many ENT appointments and hearing tests. Hyperbaric chamber was recommended by the dr. But my insurance would not cover it.
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| 60 | 2021-05-31 | feeling abnormal |
feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of...
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feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of 100; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9264) via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:45 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient's medical history includes history of colon cancer, anaemia, hypertension and asthma and drug hypersensitivity. The patient previously known allergies includes: Sulfa, EES, Augmentin, oxycodone, vancomycin, duramorph. The patient's concomitant medications included budesonide, formoterol fumarate, glycopyrronium bromide (BREZTRI AEROSPHERE), hctz, meloxicam and zolpidem tartrate (AMBIEN). It was reported that on 02Feb2021, at 08: 45 AM initially within five minutes after the vaccine, the patient felt mild heart palpitations with mild heart increase. She monitored on her (company name) watch heart rate, ECG and oxygenation level. This resolved within 15 minutes. During the day following she started having chills just generalized feeling bad. Had a low-grade fever of 100 last evening. This morning feeling tired on 03Feb2021. The outcome of the events was recovering. Therapeutic measures were not taken by the patient for resolving of the events. Follow-up attempts are completed. No further information is expected.
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| 60 | 2021-06-02 | insomnia |
shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheek...
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shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected
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| 60 | 2021-06-02 | panic reaction |
The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has...
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The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has the flu; has been experiencing runny nose, has the flu; Only pain on arm for two or three days; got a panic; got a panic; The caller's heart was really fast and heart pressure went up; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182) via an unspecified route of administration in right arm on 10May2021 at 11:30 (age at vaccination 60-year-old) at single dose for covid-19 immunisation. Medical history included tachycardia from 12Apr2021 and ongoing, transient global amnesia from 25Mar2021 and ongoing, anxiety from 25Mar2021 to an unknown date, panic reaction from 25Mar2021 to an unknown date, amnesia from 25Mar2021 to an unknown date. Concomitant medication included cannabidiol (CANNABIDIOL) taken as needed for amnesia from 28Mar2021. The patient is not taking the CBD oil right now, only takes when needed. Has not taken in two weeks, was not she should take it. Suspended for four or five days before first dose. Really does not need it. No other vaccine in four weeks. On 26May2021, patient experienced runny nose, on 25May2021 patient experienced flu like symptoms, on 10May2021 patient got a panic after receiving the first dose Pfizer Covid Vaccine on, the caller got a panic and had to stay at the vaccine facility for half an hour. The patient's heart was fast and heart pressure went up. The patient stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The patient stated this went away. The patient knew every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the patient has that problem right now. Patient's heart was fast and heart pressure went on, on 11May2021 patient experienced pain on arm for two or more days. Patient also experienced cardiac discomfort. The patient stated that the side effects were only pain on arm for two or three days and this began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. The patient is experiencing a runny nose right now had the flu but doesn't have any high temperature. The patient states she does not speak English that well HCP: the caller does not wish to provide name, address, telephone number or email. The physician stated she doesn't have a primary care physician yet. The patient was experiencing a runny nose right now began on 26May2021 and is persisting. Had the flu but doesn't have any high temperature: The patient states this began on 25May2021 is ongoing and is improving a little bit. The patient states she is taking CBD oil because she had an issue back on 25Mar2021 of amnesia. The patient has tachycardia and has issues with anxiety and panic. The patient stated after receiving the first dose Pfizer Covid Vaccine on 10May2021, the caller got a panic and had to stay that the vaccine facility for half an hour. The caller's heart was really fast and heart pressure went up. The caller stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The caller states this went away. The caller knows every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the caller has that problem right now. The caller states this went away in thirty minutes. Anxiety and panic not diagnosed, she can just feel it. This started after problem of amnesia the caller had on 25Mar2021. Transient Global Amnesia, had a problem of amnesia on 25Mar021. The patient is not taking the CBD oil right now, only takes when needed. Hasn't taken in two week, wasn't she should take it. Suspended for four or five days before first dose. Really doesn't need it. The patient received the first dose Pfizer Covid Vaccine on 10May2021 and is scheduled for the second dose on 31May2021. The patient has a runny nose right now and had the flu. The caller is asking if they should get a Covid test prior to receiving the second dose Pfizer Covid Vaccine. Only pain on arm for two or three days The patient states the side effects were only pain on arm for two or three days began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. She has recovered from the arm and everything. The patient mentioned she was scheduled to receive the second dose Pfizer Covid Vaccine next Monday, 31May2021. Patient did not undergo lab tests and procedures. The outcome of event was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
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| 60 | 2021-06-03 | insomnia |
soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was...
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soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 60 | 2021-06-03 | loss of personal independence in daily activities, nightmare |
needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotate...
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needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotated out everywhere after 30 minutes; burn a little regarding; incapacitated; injection site swelled and turned red; injection site swelled and turned red; non-anaphylactic reaction; nightmare; Bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Feb2021 (lot number: EN6198; expiration date: 30Jun2021) as 1st dose, single, dose 2 via an unspecified route of administration on 15Mar2021 (lot number: EN6204; expiration date: 30Jun2021) as 2nd dose, single for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration, administered in left deltoid on 01May2021 (lot number was 9NH54 and expiration date was 14Oct2022), at an unknown, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient family history included shingles (caller mother had shingles). On an unspecified date, the patient experienced needle was put in and burned like hell and her head kind of exploded, arm was throbbing, pain rotated out everywhere after 30 minutes, burn a little regarding, incapacitated, injection site swelled and turned red and non-anaphylactic reaction. The clinical course of the event was reported as: caller stated that her pharmacist told her to report because she had Shingrix vaccine injection on 01May2021 and had a non-anaphylactic reaction but her reaction was epic and her pharmacist said that the company would want to know this information for the numbers related to the product. It was reported that her weight was when she was fully dressed. The caller stated for Shingrix vaccine, the needle was put in and burned like hell and her head kind of exploded and that was epic. The nurse said it did burn a little regarding the patient stating Shingrix vaccine burned upon administration; stated the nurse let her go but she wanted to stay in the store for a few minutes and it felt really awkward; her head settled down and her arm was throbbing and started screaming; stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body and the pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in her arm. She stated the area where Shingrix was injected was almost like a baseball sized circle and was read and she had to drive to care for her parents and that made this a nightmare. She removed the band aid from the injection site because the band aid caused a bruise and the injection site swelled and she remembers taking the band aid off and not being able to put ice on it and could not bear the pain. She could not put ice or clothes on top of the injection site and could not take it. She reported her head was just killing her and it was ridiculous to had to use that arm and to lift it like a disabled arm, she would say she was incapacitated and only if forced could she do something under those conditions. She stated the injection site swelled and turned red and just continued to swell, turn red and was burning and hurting and did not go farther and was the size of a baseball. She reported that the other symptom was she had her head back down and no pain in her back anymore, no pain in her chest anymore, and no pain in her legs anymore. She stated the pain after Shingrix vaccine was localized but gave her a headache; states using that arm was insane and if she was not forced to use the arm she could not use it effectively and this was not an anaphylactic reaction and the reaction was not moving anywhere else; stated the area of the injection site is now black all around it like the nurse gave a bad vaccine but she did not do a bad job; stated she could see the dot where the Shingrix vaccine went in. Stated the indication for which she had Shingrix vaccine was that her mother had shown up with shingles and they took her to the emergency room on Sunday (as reported) with a rash that began to bubble so the caller called for her mother; stated her mother was transported to the hospital and the caller had been wearing gloves and thought it was contagious and it was shingles; states the six doctors for her mother in the ER pressed the caller to get Shingrix vaccine. Caller stated the reported reaction for Shingrix vaccine lasted 11 days and sort of calmed down and all she could see now was the red dot where the vaccine was administered; stated she was sure she would have to do Shingrix again due to her reaction and did not have an anaphylactic reaction but wanted to report this as she was told. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 60 | 2021-06-05 | anxiety, nervousness |
60-year-old Female was found by EMT sitting upright and complaining of being lightheaded. Client was...
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60-year-old Female was found by EMT sitting upright and complaining of being lightheaded. Client was alert and tracking with her eyes while nervous. Client had a chief complaint of anxiety post vaccination. Client stated she began to feel anxious shortly after her vaccination and requested to lie down for the duration of her observation. Client has a history of anxiety for which she is taking CBD oil. Client also has a history of new onset tachycardia and periodic irregular heart rate for which she sees a cardiologist. Client was recently diagnosed with transient amnesia. She denies any allergies. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Airway, breathing, and circulation were intact. Client denied any pain throughout her body. Client's initial vitals were a heart rate of 76 and irregular, blood pressure 160/98, respirations 20 and regular, alert and oriented to person, place, date and event, eyes equal and reactive to light, lung sounds clear bilaterally and SPO2 100% on room air. Client was shaking while anxious but consolable. Client consented to an additional 30-minute observation after her first set of vitals. She was provided water during her observation. Her remaining vitals at 1152 - 158/98, pulse 86, O2 99% respirations 16. After approximately 5 minutes, client reported that she felt much "better" and remained calm for the rest of her observation. Client's vitals improved at the completion of her observation with a heart rate of 80 and regular, respirations 16, blood pressure 140/88 and O2 98%.. Client departed vaccination site after 30mins of observation feeling "better".
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| 60 | 2021-06-07 | depression, anxiety | Anxiety Depression |
| 60 | 2021-06-07 | poor quality sleep |
She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that...
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She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 60 | 2021-06-08 | feeling abnormal |
Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chill...
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Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.
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| 60 | 2021-06-08 | feeling abnormal |
vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces ...
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vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown. Information about lot/batch no has been requested.
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| 60 | 2021-06-08 | memory impairment |
Forgetting where I parked car; not getting everything I went to the store for. Burning food on stove...
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Forgetting where I parked car; not getting everything I went to the store for. Burning food on stove.; patient took 1st and 2nd dose both on 02Apr2021; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 60-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0150, expiration date not reported), via an unspecified route of administration in left arm on 02Apr2021 10:30 (age at vaccination 60years old) as 1st dose, single dose for covid-19 immunisation. Reportedly, same day patient was administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0167, expiration date not reported) via an unspecified route of administration in right arm on 02Apr2021 as 2nd dose, single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Medical history included fibromyalgia, allergies to tannins from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 27May2021 11:30 the patient experienced forgetting where he parked car, not getting everything he went to the store for and burning food on stove. The patient did not receive any treatment for the adverse events. The case was assessed as non-serious as per the reporter. The clinical outcome of the event was unknown. No follow up attempts are possible. No further information is expected.
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| 60 | 2021-06-10 | feeling abnormal |
really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had ch...
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really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had chills; After her second COVID-19 Vaccine, she had a headache; After her second COVID-19 Vaccine, she was tired; her hands and feet got real swollen; She said she hadn't felt right; hadn't felt right; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration in left arm on 23Mar2021 between 17:20-17:30 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis (from 2003), she has had rheumatoid arthritis for almost 20 years. Concomitant medication included Xeljanz XR 11mg. On 24Mar2021, patient had fever of 101.5 degrees Fahrenheit, chills, headache, she was tired. On an unspecified date in Mar2021, her hands and feet got real swollen, she had not felt right since she had COVID-19 Vaccine. It was reported that patient received her second shot of Pfizer (COVID-19) Vaccine on 13Apr2021 and experienced really bad flare up of rheumatoid arthritis in Apr2021. The patient stated she got both doses of the Pfizer (COVID-19) Vaccine, and after her second (COVID-19) Vaccine, she had a really bad flare up of rheumatoid arthritis. The patient stated her doctor put her on Prednisone for 2 weeks. Reported she had received her second COVID-19 Vaccine dose right before her 61st birthday. She said she went to her rheumatologist, and her rheumatologist told her she should report her side effects to Pfizer. She said she already reported her COVID-19 Vaccine side effects on V-Safe. Patient took 1 Tylenol (8HR Arthritis Pain Extended Release 650mg, Lot Number: LPA095, Expiration Date: Aug2020) for a fever of 101.5 degrees Fahrenheit. She said the Tylenol helped her fever, providing. Reported the Tylenol 8HR Arthritis Pain Extended Release 650mg was expired, but the product still worked. Patient stated for Rheumatoid Arthritis Flare Up, her rheumatologist prescribed 1 Prednisone 5mg tablet, once a day, for 2 weeks. She said she saw her rheumatologist on 17May2021. She said she completed her Prednisone 5mg prescription, and the Prednisone 5mg tablets were dispensed in a pharmacy bottle, and she didn't have the Prednisone 5mg NDC, Lot, and Expiration Date. Reported she was feeling better now, but wanted to report her Pfizer BioNTech COVID-19 Vaccine side effects to Pfizer, so she could help other people with rheumatoid arthritis. Reported she continued to take her Xeljanz XR 11mg while she took the Prednisone 5mg tablets, providing the Xeljanz XR 11mg (NDC Number: 0069-0501-30, LOT Number: DJ2906, Expiration Date: 31May2022). Reported she was feeling better now, but she was not 100%. She said she could actually walk now. She said she still had swelling in her hands and feet. She said the swelling had improved in her hands, saying she could make a fist now, but she couldn't wear her wedding ring. She her sandals still felt tight on her feet. Reported she was very reluctant to get a COVID-19 Vaccine booster shot in 12 months with her auto immune disease. She said she was not going to get the COVID-19 Vaccine booster, if she was going to have the same reaction she had after her second COVID-19 Vaccine dose. Patient asked if Pfizer had done any studies with people who had rheumatoid arthritis and the COVID-19 Vaccine. The outcome of the event fever, chills, headache was recovered on 25Mar2021 and outcome of the other events was recovering. Follow up attempts are needed. Further information has been requested.
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| 61 | 2021-01-03 | thinking abnormal, disturbance in attention |
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ...
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About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
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| 61 | 2021-01-04 | depressed mood |
Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Satur...
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Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu
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| 61 | 2021-01-04 | feeling abnormal |
aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was fr...
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aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
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| 61 | 2021-01-05 | feeling abnormal |
I went to the emergency room which after the Pfizer injection I had numbness sensation to my face a...
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I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.
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| 61 | 2021-01-06 | anxiety, fear |
worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her vo...
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worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.
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| 61 | 2021-01-06 | feeling abnormal |
left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the s...
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left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe
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| 61 | 2021-01-06 | impaired work ability |
Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction last...
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Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.
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| 61 | 2021-01-06 | mental impairment, anxiety, disturbance in attention |
Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside t...
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Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-01-08 | anxiety |
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d...
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About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
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| 61 | 2021-01-10 | impaired work ability, irritability, anxiety |
Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritabilit...
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Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.
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| 61 | 2021-01-11 | confusional state |
After patient had received vaccine, a vaccinator was called by a member of the healthcare facility t...
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After patient had received vaccine, a vaccinator was called by a member of the healthcare facility to assess the patient. The patient was jittery and exhibited signs of confusion approximately 20 minutes (3PM) after her vaccination. The vaccinator asked if she was diabetic and the patient replied "yes" and takes metformin. Further questioning revealed that the patient had not eaten since 9AM - it was then around 3PM. The ambulance was called and the patient went to the hospital. Probe revealed that she had not taken her diabetic medication and that the patient had not eaten or drink. Patient was encouraged by vaccinator to eat on time and take her medicine as prescribed.
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| 61 | 2021-01-11 | feeling abnormal |
Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hour...
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Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.
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| 61 | 2021-01-12 | insomnia |
Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started a...
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Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started at 11:00 p.m. on 11/12/21. Not able to sleep in the night, headache started sometime in the night. Fever and chills were gone by morning. Headache resolved about 5:00 p.m. on 1/13/21.
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| 61 | 2021-01-12 | nervousness |
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo...
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Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
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| 61 | 2021-01-13 | amnesia, depression | Short term memory loss, Severe fatigue, Chills, Mild HA, Depression - lasted 5 hours and was gone. |
| 61 | 2021-01-14 | impaired work ability |
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje...
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Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
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| 61 | 2021-01-17 | anxiety, insomnia, impaired work ability |
Patient seen on 1/8, 1/9 and 1/11 in ER at Hospital for Chest pain. Work up negative for acute coro...
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Patient seen on 1/8, 1/9 and 1/11 in ER at Hospital for Chest pain. Work up negative for acute coronary syndrome. This started hours after 2nd dose of COVID 19 vaccine. Pleuritic type pain. She was sent with aspirin and monitored. On her 3rd ER visit was given medication for anxiety and to aid in sleep (ativan). Symptoms continued and she was off work the week of 1/11 because of this. Seen in Clinic on 1/18 and symptoms had stopped on 1/17.
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| 61 | 2021-01-17 | feeling abnormal |
2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout mu...
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2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.
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| 61 | 2021-01-18 | feeling abnormal |
Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches...
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Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.
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| 61 | 2021-01-18 | excessive sleepiness |
Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minute...
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Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.
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| 61 | 2021-01-18 | loss of personal independence in daily activities |
Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal head...
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Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 61 | 2021-01-19 | anxiety, feeling abnormal |
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa...
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I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
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| 61 | 2021-01-19 | feeling abnormal |
Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could bar...
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Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination
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| 61 | 2021-01-20 | feeling abnormal |
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fati...
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felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
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| 61 | 2021-01-20 | loss of personal independence in daily activities |
The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint...
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The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.
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| 61 | 2021-01-21 | impaired work ability, nervousness |
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe...
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I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
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| 61 | 2021-01-21 | impaired work ability |
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine....
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STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
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| 61 | 2021-01-23 | sleep disorder | Severe base of neck and frontal head pain. Unable to sleep. Lasted x 2 days; 01-18 & 01-19-21. |
| 61 | 2021-01-24 | anxiety, disorientation |
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor...
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Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
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| 61 | 2021-01-24 | feeling abnormal |
Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left...
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Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left eye felt "weird." Took Advil, got better after no difference with Tylenol. Then stopped the Advil and symptoms persisted. Then had tingling of head and neck. Saw her physician and Carotid flow study was normal. Waiting for MRI approval. Has been working with the symptoms.
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| 61 | 2021-01-26 | feeling abnormal |
After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was ...
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After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.
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| 61 | 2021-01-26 | insomnia, feeling abnormal | Headache 1st day Day 2/3 severe body aches, muscle and joint pain, fatigue, brain fog, insomnia |
| 61 | 2021-01-26 | insomnia, impaired work ability |
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl...
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Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
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| 61 | 2021-01-26 | loss of personal independence in daily activities, impaired work ability |
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes...
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unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-01-27 | anxiety |
Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for...
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Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.
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| 61 | 2021-01-29 | impaired work ability |
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ...
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alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
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| 61 | 2021-01-30 | sleep disorder, feeling abnormal |
12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, fe...
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12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)
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| 61 | 2021-01-31 | impaired work ability, insomnia |
(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she ...
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(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.
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| 61 | 2021-01-31 | loss of personal independence in daily activities |
Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to...
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Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.
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| 61 | 2021-02-04 | anxiety, thinking abnormal, nervousness |
feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was ...
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feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
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| 61 | 2021-02-06 | feeling abnormal |
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba...
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I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
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| 61 | 2021-02-07 | nervousness |
facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no it...
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facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.
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| 61 | 2021-02-08 | anxiety |
Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated w...
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Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.
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| 61 | 2021-02-08 | anxiety | Rapid heart beat, high blood pressure, sinuses blocked, and anxiety. |
| 61 | 2021-02-09 | disorientation, confusional state |
30 minutes after injection: severe headache, general feeling of illness. Following day in the mornin...
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30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing
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| 61 | 2021-02-09 | feeling abnormal |
Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneou...
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Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.
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| 61 | 2021-02-11 | feeling abnormal |
pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. ...
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pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. She was checked out by the attending nurse at the vaccine facility. Her pulse was 120 and BP was 189/89. Pt drank a bottle of water while her pulse came down. About 5 minutes later her heart was racing again and BP back up. She was monitored for additional 15 minutes. During this time she had another episode with the same symptoms so she was rushed to the ER. Her heart rate was 110 and blood pressure still 189/? She was monitored for about an hour and 20 minutes. Pt was released from ER about and 1 1/2 ago and has not had another episode so far. She was told to FU w/ PCP in 2-3 days.
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| 61 | 2021-02-11 | feeling abnormal |
AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPOR...
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AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.
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| 61 | 2021-02-14 | abnormal dreams, crying |
I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a ...
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I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.
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| 61 | 2021-02-14 | feeling abnormal |
After patient received first dose of Covid vaccine patient experienced a reaction as described "feel...
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After patient received first dose of Covid vaccine patient experienced a reaction as described "feel fuzzy" and lack of self awareness five minutes after dose. That evening patient contacted her primary care provider and has not spoken until then. Patient still complains of not feeling herself and currently has not received her second dose and is worried of lack of self awareness.
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| 61 | 2021-02-18 | feeling abnormal |
Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint...
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Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.
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| 61 | 2021-02-18 | feeling abnormal |
Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs f...
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Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.
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| 61 | 2021-02-23 | confusional state, amnesia |
I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an...
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I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.
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| 61 | 2021-02-27 | feeling abnormal |
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Hea...
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Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.
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| 61 | 2021-03-02 | insomnia, feeling abnormal |
rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't go...
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rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.
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| 61 | 2021-03-04 | amnesia, confusional state |
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly reso...
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Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
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| 61 | 2021-03-04 | feeling abnormal |
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen...
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still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-03-06 | disturbance in attention, impaired work ability, confusional state |
On day 2, I developed confusion and could not focus making it impossible for me to complete my work ...
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On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
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| 61 | 2021-03-06 | loss of personal independence in daily activities |
With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., var...
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With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., varicose vein in left thigh was extremely throbbing, I could barely walk on stiff knee. I had a trouble night of pain on Sunday 2-28, Monday , I could barely walk on left leg & still had thigh pain, I almost fell down stairs 2x from leg buckling, I did fall down in the kitchen and the fam. room from knee buckling, not supporting my body. I used heat, ice, rest, ibupfen, advil, tynelol, ben-gay, icyhot, CBD cream. I used it all. Today is one week and the thigh pain is gone but knee is still stiff. It no longer buckles, but I still can not fully walk. I am using a cane. I have been working from home all week, but can not cook for myself. I have to sit in a chair in the shower. I did contact my Dr., who said keep doing everything I am doing, that as long as it getting better every day. I am afraid to take 2nd dose.
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| 61 | 2021-03-10 | anxiety |
Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy ...
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Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy throat. Exam was normal. Calm patient, clear lungs, strong pulse. No rash. Gave positive answers to all questions, such as do you itch 'a little,' do you have trouble breathing 'a little.' I suspect anxiety. Given Benadryl and continued monitoring. All symptoms resolved. Observed total of 45 minutes and discharged home. Ok for next vaccine.
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| 61 | 2021-03-10 | sleep disorder, crying, hallucination |
I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bath...
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I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bathroom three times during the night and could not stop them while getting up and walking to bathroom. I would sit up in bed and even get out of bed but they would not stop. I?ve never had this happen ever in my life. I was crying out and sweating. I have also had severe fatigue, even much more than what I experience with CFS.
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| 61 | 2021-03-11 | confusional state |
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
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| 61 | 2021-03-11 | excessive sleepiness |
Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I...
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Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.
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| 61 | 2021-03-13 | excessive sleepiness |
Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping...
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Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping 15-18 hours per day)
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| 61 | 2021-03-14 | sensation of foreign body, emotional distress |
Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was ...
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Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.
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| 61 | 2021-03-15 | anxiety |
3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TO...
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3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TODAY AND 2 BITES OF CANDIES'. GIVEN JUICE AND CRACKERS. 7:25PM 'FEELS BETTER'. AMBULATORY TO EXIT WITHOUT DISTRESS. 3-11-21 9:30AM PT STATES 'FEELS 100% BETTER NOW'.
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| 61 | 2021-03-15 | insomnia |
Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten...
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Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten older but for 6 weeks after the second dose it felt as bad as it ever has. It kept me up at night and I had to take OTC pain relievers.
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| 61 | 2021-03-16 | anxiety, feeling abnormal |
Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 mi...
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Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.
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| 61 | 2021-03-16 | confusional state |
acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who...
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acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who convinced his mother to come in to ED)
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| 61 | 2021-03-17 | anxiety | anxiety, numbness around mouth but resolved |
| 61 | 2021-03-17 | anxiety | anxiety, lightheaded, flushes - resolved; VS 97%, HR 84 |
| 61 | 2021-03-17 | insomnia | Headache INSOMNIA, INJECTION SITE PAIN Narrative: |
| 61 | 2021-03-18 | feeling abnormal, loss of personal independence in daily activities |
I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by ...
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I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).
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| 61 | 2021-03-20 | feeling abnormal |
Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma att...
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Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.
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| 61 | 2021-03-20 | sleep disorder |
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, starte...
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1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
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| 61 | 2021-03-21 | anxiety |
Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute obse...
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Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.
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| 61 | 2021-03-21 | excessive sleepiness |
Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00...
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Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone
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| 61 | 2021-03-21 | impaired work ability |
On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with...
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On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.
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| 61 | 2021-03-22 | feeling abnormal |
Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was nor...
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Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.
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| 61 | 2021-03-22 | impaired work ability |
Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump unde...
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Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.
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| 61 | 2021-03-23 | insomnia |
I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right sid...
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I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.
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| 61 | 2021-03-24 | disturbance in attention |
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh...
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Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
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| 61 | 2021-03-24 | loss of personal independence in daily activities, excessive sleepiness |
Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on Mar...
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Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.
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| 61 | 2021-03-24 | loss of personal independence in daily activities |
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10...
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On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
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| 61 | 2021-03-24 | sensation of foreign body |
Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she...
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Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she is able to swallow without difficulty. She denies any shortness of breath, chest pain, nausea, rash, or any other symptoms. Benadryl 25 mg given. Continued to monitor and improved
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| 61 | 2021-03-25 | anxiety |
Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site...
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Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.
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| 61 | 2021-03-25 | feeling abnormal |
Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the che...
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Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.
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| 61 | 2021-03-26 | feeling abnormal, nervousness |
Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p...
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Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.
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| 61 | 2021-03-26 | impaired work ability |
Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later b...
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Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.
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| 61 | 2021-03-27 | feeling abnormal | Both arms feeling like on fire. Headache, body aches, stomach ache, throat feels tight |
| 61 | 2021-03-27 | hallucination |
total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning...
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total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon
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| 61 | 2021-03-27 | nervousness | lightheaded, dizzy,feeling nervous 160/90,82, 16 |
| 61 | 2021-03-27 | sleep disorder |
Speeding-like an extreme caffeine high. Couldn?t sleep for two nights. Blinding headache. Diarrhea. ...
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Speeding-like an extreme caffeine high. Couldn?t sleep for two nights. Blinding headache. Diarrhea. Chewed up inside of mouth until bleeding. On day three and symptoms slowly leaving. Now slight headache and extreme fatigue.
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| 61 | 2021-03-29 | disorientation, loss of personal independence in daily activities |
Within hours became disoriented, thirsty and achy. Next morning, arm was numb and fingers tingly, ...
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Within hours became disoriented, thirsty and achy. Next morning, arm was numb and fingers tingly, Achy, fever, nausea, headache, extreme thirst, disoriented. Extremely sore arm that I couldn't lift to my waistline without extreme pain.. Hard to dress/undress. Never felt so sick in my life!
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| 61 | 2021-03-29 | feeling abnormal |
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li...
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Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
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| 61 | 2021-03-29 | impaired work ability, insomnia |
Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme...
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Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day: big headache; very light headed; some coughing; short of breath; nausea (stayed home from work). Not restful sleep. 3rd day: pressure headache; very light headed (went to work). Very tired at night. Hard time sleeping. 4th day: light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow. Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.
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| 61 | 2021-03-30 | feeling abnormal, agitation |
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ...
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Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
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| 61 | 2021-03-30 | feeling abnormal |
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet...
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Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
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| 61 | 2021-03-31 | feeling abnormal |
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quen...
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felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
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| 61 | 2021-03-31 | mental status changes |
received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and v...
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received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.
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| 61 | 2021-04-01 | feeling abnormal |
Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermomet...
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Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.
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| 61 | 2021-04-02 | feeling abnormal, loss of personal independence in daily activities |
Massive headache, so bad I could not get out of bed. Fever of 102 that was gone the next day. Sore, ...
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Massive headache, so bad I could not get out of bed. Fever of 102 that was gone the next day. Sore, tired, cranky. I still have a headache only I can function. It is a 4 today on a pain scale of 1 to 10. On April 1st it was so bad I could not get out of bed. I felt like my head was a giant toothache. I am not too sure about getting the second dose. I was truly frightened. I don't think I have ever felt that bad. Having kids was easier.
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| 61 | 2021-04-03 | insomnia |
Vaccination was at 1pm. At 2am I got a horrible headache- stabbing pains in the back upper right ?co...
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Vaccination was at 1pm. At 2am I got a horrible headache- stabbing pains in the back upper right ?corner? of my head. Couldn?t sleep. I would test the frequency every once and a while. I had 1-4 sharp pains every minute. I talked to my doctor at 2pm that day. She said I could take 800mg Ibuprofen/8 hrs. That worked. Had to do this for 2 days after my shot. I was very tired. I was fine after that.
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| 61 | 2021-04-03 | sleep disorder |
Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit ...
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Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit 2pm next day.
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| 61 | 2021-04-03 | thinking abnormal |
ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joi...
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ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
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| 61 | 2021-04-05 | disorientation, excessive sleepiness |
I was fine for 3 days after the shot. On the 4th day I was tired in the morning and had a headache. ...
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I was fine for 3 days after the shot. On the 4th day I was tired in the morning and had a headache. During the morning I started becoming disoriented and very tired. I was at work. I sat down and slept for 3 hours not hearing anyone. When I woke up my coworkers said I moved about 10 things around where they didn't belong. Like a cactus in the fridge along with a soap dispenser. I don't remember any of it. I felt better when I woke up. When I got home I slept for 11 hours. I was a little groggy the next day. I was fine 2 days later.
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| 61 | 2021-04-05 | feeling abnormal, crying, depression |
3 days later began to feel very depressed, emotionally volatile, crying a lot. It has continued wit...
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3 days later began to feel very depressed, emotionally volatile, crying a lot. It has continued with some better days and some awful days, I am now 7 days post vaccination and today was awful. I have not had any major physical reactions other than some fog and headache.
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| 61 | 2021-04-05 | feeling abnormal |
5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNES...
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5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNESS IN HER LEGS. SHE LOOKED PALE AND HER SKIN WAS CLAMY. GAVE HER SOME WATER AND 1 GLUCOSE TABLET (4GRAM CARBOHYDRATE). TOOK HER BLOOD PRESSURE AS WAS LOW AT 76/51, RECHECK 86/62, RECHECK, 86/58. ATTEMPTED TO CALL 911 BUT PATIENT REFUSED AND WANTED HER DAUGHTER TO COME GET HER. AT 3:54 PM SHE REPORTED THAT THE DIZZINESS WAS GETTING BETTER AND BLOOD PRESSUER RECHECK WAS 98/68. AT 4:01 HER BLOOD PRESSURE WAS 117/71 HR 73 THEN EVENTUALLY CAME BACK UP TO 128/80 AT 4:08PM. PATIENT LEFT AT 4:17PM. WILL FOLLOW UP WITH A PHONE CALL TODAY.
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| 61 | 2021-04-06 | amnesia, abnormal behaviour |
Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs ac...
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Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.
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| 61 | 2021-04-06 | feeling abnormal |
Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that ...
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Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that I received shot swelled alot. I not experience that with previous flu shots or my pneumonia shot. I felt weird and sort of sick for 2 weeks.
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| 61 | 2021-04-06 | insomnia |
In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash ac...
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In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold.
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| 61 | 2021-04-06 | sleep disorder |
Began with soreness at the injection site and tiredness about 16hours post injection. Then I had bod...
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Began with soreness at the injection site and tiredness about 16hours post injection. Then I had body aches headache and low grade fever (99-100 degrees), about 18 hours after the injection. I had a rough night waking intermittently but all symptoms were gone when I woke at 10:30 am on 4/7/2021.
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| 61 | 2021-04-06 | sleep disorder |
In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash ac...
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In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As if this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday
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| 61 | 2021-04-07 | disorientation |
The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The...
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The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.
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| 61 | 2021-04-07 | feeling abnormal |
Arm soreness/pain impulses upon lifting of arm; pain about 10 minutes after injection; a fluttered f...
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Arm soreness/pain impulses upon lifting of arm; pain about 10 minutes after injection; a fluttered feeling as if a fast heart rate; Difficulty lifting arm; This is a spontaneous report from a contactable nurse. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 16:00 (Batch/Lot Number: EL9262) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension), Elevated Cholesterol, glaucoma, GERD (gastroesophageal reflux disease) and Known Allergies: black pepper. The patient's concomitant medications were not reported. The patient previously took Flexeril, codeine and fentanyl for all these drugs experienced drug hypersensitivity. Initially a fluttered feeling as if a fast heart rate, but 60 second counts revealed pulse regular and no more than 80. Arm soreness; pain about 10 minutes after injection. Continued despite use of Tylenol and heat packs. Difficulty lifting arm; pain impulses upon lifting of arm on 23Jan2021 16:00. The patient underwent lab tests and procedures which included heart rate was 80/min. The outcome of the events was unknown.
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| 61 | 2021-04-07 | sleep disorder |
In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash ac...
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In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold. Note that after my shot I was out until about 4:30 pm. While out, I noticed that my face and neck felt hot and my neck was getting itchy, but I did not check it. After returning home, the itchiness, chills. etc. slowly increased until at 6:30 pm I was very
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| 61 | 2021-04-08 | feeling abnormal |
Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofe...
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Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofen, severe fatigue, could not stay awake more than half hour, fuzzy headed feeling, constant ringing in the ears , day 4 of effects couldn't catch my breath when walking more than 10 feet. Day 6 still have ringing in ears, some fatigue, breathing better but not 100%.
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| 61 | 2021-04-09 | feeling abnormal |
feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of...
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feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.
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| 61 | 2021-04-09 | loss of personal independence in daily activities |
Approximately 12 hours after vaccines, chills, fatigue, nausea, weakness. These lasted 48 hours afte...
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Approximately 12 hours after vaccines, chills, fatigue, nausea, weakness. These lasted 48 hours after start of symptoms 2nd vaccine symptoms were worse then previous vaccine and include having diarrhea. Still have activity intolerance
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| 61 | 2021-04-10 | excessive sleepiness |
Threw up about an hour later 2pm. Threw up 2 more times in about a 3hr. total time frame. Achy and...
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Threw up about an hour later 2pm. Threw up 2 more times in about a 3hr. total time frame. Achy and sore went to bed and slept till 4:30am. Felt better but still achy with a headache. Sun. feeling better.
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| 61 | 2021-04-11 | feeling abnormal |
Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling i...
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Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling in both hands, difficulty swallowing, and feeling funny. She states as soon as she got it she developed an immediate headache, on her drive home she became lightheaded and had pins and needles sensation in her face and got a strange aura that lasted all her way home. She said for a while she felt like she couldn't swallow. She feels that she might have had a panic attack versus an adverse reaction to the vaccine and is declining any further evaluation.
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| 61 | 2021-04-11 | feeling abnormal |
Patient returns to Covid Clinic 3 hours after injection with her husband. CC: Feeling Funny, Weaknes...
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Patient returns to Covid Clinic 3 hours after injection with her husband. CC: Feeling Funny, Weakness, and Shuffling Gait. Denies Respiratory involvement. Vital Signs Stable No Rash observed. Patient reports s/s started while shopping at shopping center three hours after injection. Reports history of Anxiety and reports taking Xanax the night before the Covid Appointment.
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| 61 | 2021-04-12 | anxiety, sleep disorder |
Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm t...
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Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm the evening of the injection and the next day. Joint/muscle aches and pains nights the 10th and 11th that interrupted sleep; took acetaminophen. Aches during the day and tired the 11th, 12th and 13th (so far). Strange taste in mouth, upset stomach 12th and 13th (so far). Not looking forward to second dose though happy to have started process.
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| 61 | 2021-04-13 | disturbance in attention, disorientation |
I started symptoms late Sunday 4/11/2021, on Monday 4/12/2021 I became very lethargic, aches and p...
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I started symptoms late Sunday 4/11/2021, on Monday 4/12/2021 I became very lethargic, aches and pains, severe headache, all night has night sweats and chills., temperature reached 101.4 Tuesday 4/13/2021, felt disoriented, (this bothered me, I couldn?t even have a conversation with work or psychiatrist. I could think straight. Still headache, no fever. Very sleepy and achy.. started feeling better later in the evening. Wednesday, 4/14/2021. Hardly any side affects at all. Minor headache and sweats.
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| 61 | 2021-04-13 | sleep disorder |
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills...
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Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
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| 61 | 2021-04-14 | confusional state | dizzy, weak, stomach pain, loose bowel movements, confusion, heart palpitations |
| 61 | 2021-04-14 | fear |
At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin ...
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At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.
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| 61 | 2021-04-14 | feeling abnormal |
Lightheadedness/dizziness the second day after receiving the shot (was fine the day after). Couldn'...
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Lightheadedness/dizziness the second day after receiving the shot (was fine the day after). Couldn't stand for more than a few minutes without support. The third day still a bit lightheaded/foggy, but much better than the day before.
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| 61 | 2021-04-14 | excessive sleepiness, feeling abnormal |
April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I ha...
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April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I had a headache, nausea, no appetite, chills, fever up to 101.6, constipated and overall felt crappy - slept most of the day. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 14th - 7:15 am - 11:00 pm - I had a headache (not as bad as previous day, nausea, no appetite, chills, fever up to 99.4, constipated and overall felt crappy - slept a bit less than previous day. Between 2:00 am and 6:00 am, I believe the fever broke - sweats were consistent. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 15th - 7-20 am - current - All above listed symptoms have gone away. I also had a bowel movement twice today. I feel a bit tired but almost back to normal.
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| 61 | 2021-04-15 | anxiety |
1 hour after shot numbness left side of face. 19 hours later extreme fatigue. 24 hours later dizzin...
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1 hour after shot numbness left side of face. 19 hours later extreme fatigue. 24 hours later dizziness. 11 days later extreme anxiety. 12 days later chills, body ache, fatigue, and anxiety. 13 days later severe ocular migraine.
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| 61 | 2021-04-15 | anxiety |
after receiving vaccine started to get anxious due to environmental factors was feeling faint and wa...
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after receiving vaccine started to get anxious due to environmental factors was feeling faint and wanted to lay down assisted to stretcher placed in trendelenburg snacks and water and juice provided bp elevated sat up bp cont to be elevated pt states having anxious thoughts about covid vaccine expressed to nurse bp elevated pt agrees to lay down and rest for a few minutes and close eyes deep breathing exercises enc to pt. per pt stress relieved after a few minutes and feeling better and requesting to leave, escorted to exit ambulated without difficutly, spouse awaiting in car and driving pt home. pt left at 1053 vs as noted VS 1015 bp 144/89 hr 72 rr 18 o2 95, 1020 bp 157/91 hr 80 rr 18 o2 98 1025 bp 177/107 hr 81 rr 18 o2 100 1035 bp 162/83, 1041 bp 137/87 1045 bp 155/84 1051 148/89
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| 61 | 2021-04-15 | feeling abnormal |
Pt reports feeling fuzzy (mental clarity wise) and a buzzing feeling since receiving Pfizer COVID-1...
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Pt reports feeling fuzzy (mental clarity wise) and a buzzing feeling since receiving Pfizer COVID-19 vaccine #1. Pt reports after receiving Pfizer COVID-19 vaccine #2, buzzing has gotten slightly worse. Pt reports when she takes a deep breath it causes her breath to catch and for her to cough. Pt reports no SOB or difficulty breathing.
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| 61 | 2021-04-15 | sleep disorder |
left leg seriously cramped up around 11pm last night waking me out of sleep. continues to feel wor...
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left leg seriously cramped up around 11pm last night waking me out of sleep. continues to feel worse it is 9:50am . can barely move left leg
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| 61 | 2021-04-16 | impaired work ability |
Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful...
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Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful. The issues move from area to area and seem to inflame fatty areas most. I thought this would go away and didn't document with pictures, like I should have. I now have a couple of pictures and will continue to do so. I've tried hot baths, cold packs, hot packs, elevating the area and topical relievers. I couldn't feel the heat of the pain reliever on the affected area. This has been absolutely debilitating and I've had to miss some work because of it.
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| 61 | 2021-04-17 | feeling abnormal |
Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Br...
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Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Brain 4/17/2021, all day Low grade Fever 4/17/2021, 1:00pm-middle of the night when I woke up sweating, 99 degrees during the day time hours Took no fever reducing medications during this time.
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| 61 | 2021-04-17 | irritability |
This is a spontaneous report from received from contactable consumer. A 61-year-old female patient r...
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This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
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| 61 | 2021-04-17 | nightmare, nervousness, feeling abnormal |
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water...
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My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
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| 61 | 2021-04-18 | insomnia |
Started with slightly sore arm, and a headache, headache got worse, took advil, didn't sleep well, s...
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Started with slightly sore arm, and a headache, headache got worse, took advil, didn't sleep well, severe headache, muscle and joint pain, took more advil. Morning, felt like a flu, slight fever, body aches, joints, major pain trying to lift left (shot) arm. Not severe enough to seek medical attention.
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| 61 | 2021-04-18 | sleep disorder | tinnitus - constant high pitched whistling sound in my ears, intensity varies, wakes me up at night |
| 61 | 2021-04-19 | anxiety |
Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my...
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Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.
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| 61 | 2021-04-19 | confusional state |
Patient suffered a syncopal episode and confusion while under observation following her booster vacc...
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Patient suffered a syncopal episode and confusion while under observation following her booster vaccination. Patient has a history of diabetic related emergencies but this syncope/confusion resolved itself while under the care of on site paramedics. Patient was transported to a hospital of her choosing.
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| 61 | 2021-04-19 | feeling abnormal, agitation, crying |
DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid...
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DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.
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| 61 | 2021-04-19 | insomnia, feeling abnormal |
Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- f...
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Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- for three day-Tylenol, rest, water Slept all Saturday following, most of Sunday, Some of Monday Insomnia Sunday night about four hours, Monday about two hours. Internal external mouth sores. Still healing from outside sores Brain Fog. Took about three weeks for brain fog to go away from first to second shot. Still have brain fog from second shot which what I am reporting on here.
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| 61 | 2021-04-19 | insomnia |
This was my second COVID dose, it felt completely different from the first one, which was given at a...
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This was my second COVID dose, it felt completely different from the first one, which was given at a different pharmacy. When it was being injected, it felt like the vaccine was pooling in my arm and the injection took much longer than the first one. My arm felt heavy within 30 minutes of getting the vaccine. About two hours later, I could not lift my arm more than 10% without terrible pain. I could not sleep even taking Advil. After three days, the intensity lessened some, but I still cannot lift my arm certain ways without a lot of pain and it is keeping me awake as it just aches. I cannot lay on that side either, as the pain becomes intolerable.
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| 61 | 2021-04-19 | sleep disorder |
Chills, restless sleep amd headache. Chills ended in the morning, 6 hours, headache and fatigue last...
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Chills, restless sleep amd headache. Chills ended in the morning, 6 hours, headache and fatigue lasted till evening, 12 hours +/-
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| 61 | 2021-04-20 | confusional state |
severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started...
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severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 61 | 2021-04-21 | feeling abnormal, disturbance in attention | Sore left arm even tho shot was in right. Very foggy brain...lack of focus for a day after shot. |
| 61 | 2021-04-21 | loss of personal independence in daily activities |
Woke up early the night of the shot with severe pain in left are below shoulder where shot was given...
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Woke up early the night of the shot with severe pain in left are below shoulder where shot was given. My arm has been painful to move..I thought would eventually go away but never did. Three weeks later still very painful and makes my job even more painful to do. It's a continual ache and hard to move.
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| 61 | 2021-04-21 | sleep disorder |
I had done some weight lifting on Wednesday morning, the day before dose 2. May have aggravated a ne...
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I had done some weight lifting on Wednesday morning, the day before dose 2. May have aggravated a nerve in my back but had no sensation of this until acute pain from mid upper back across shoulder and down right arm. Began exactly 12 hours post vaccine. And woke me from deep sleep. Could not get relief for several days until I contacted provider and was given Flexeril and Aleve. Could not lay down or sleep due to position of nerve in my back. (Vaccine administered in Left arm. ) Have never had a problem previously like this in my back. I exercise regularly. I surmise that if this nerve was aggravated, the inflammation induced by the vaccine made this worse where no vaccine and I would not have had a problem. Friday followed with typical side effects of lethargy and tiredness. Experiencing slight mobility issues in right arm post 13 days vaccination.
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| 61 | 2021-04-24 | excessive sleepiness |
Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and sl...
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Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and slept all night; She just gets hot; Feeling unwell; blood pressure was out of control; lymph nodes are not as bad, they are hurting; She is having hot flashes; Tiredness/ she is still tired; Muscle and joint pain; swollen lymph nodes under arm; muscle and joint pain; Chills; Headaches; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8732 or LR8732) first dose on 03Apr2021 08:30 on right arm at single dose for COVID-19 immunization. Medical history included ongoing High blood pressure (Has had a long time), Breast cancer (Has had 6 years) and covid in Feb2021. History of all previously immunizations was No. Prior vaccincations wtihin 4 weeks was No. AE's following prior vaccinations was No. Concomitant medications included anastrozole (ARIMIDEX, strength 20 mg) for breast cancer (Has not taken the last 3 days, Did not want to take with the shot), bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HCT) for Blood pressure (States that she was taking 5-6.25mg and increased dose to taking 10 in the morning and 5 at night) and ongoing Vitamins. States that in Feb2021 had Covid and had gotten over that and was discharged. States that she might have had mild Covid and with all of the variances coming out, she wanted to get the vaccine. States that she got her first dose on Saturday (03Apr2021) and didn't know if she hadn't waited long enough. Caller states that she has been having terrible reactions. Has been having injection site pain but even had that with the flu shot. States that she has been experiencing tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. Has also been experiencing nausea and can hardly hold her head up. States that she slept all day yesterday, and slept all night. Woke up this morning feeling a little bit better, then the side effects took a hold of her again. Caller states that cancer meds made her gain weight and hasn't been able to get rid of it. Noticed Tiredness yesterday (04Apr2021) when she woke up. States that she had the vaccine on Saturday the 03Apr2021 at 8:30am, started to have headache that night. States when she woke up yesterday (04Apr2021), she started experiencing all of the other symptoms, tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. States that when she woke this morning, had thought everything was a little better but, then it hit her again. Clarifies she is still tired, and the headache still has not gone away. This morning (05Apr2021) she is having hot flashes, not so much the chills. The chills are still there but not nearly as bad, she just gets hot. She has been experiencing nausea and feeling unwell. States that the lymph nodes are not as bad, they are hurting but, not as bad. States that it is hopefully doing what it is supposed to do. States that she has been taking only Tylenol but has not taking it yet today. States that she is super scared to get the second shot. If this happened with the first shot, is terrified for the second shot. States that she has been taking Tylenol every four hours and is such a lightweight that she has only been taking one Tylenol every four hours. Caller states that she is supposed to be back 24Apr2021 for second shot but does not know if she can go through with it. States that this was recently increased when her blood pressure was out of control when she had gotten Covid. States that she was taking 5-6.25mg and her dose was increased dose to taking 10 in the morning and 5 at night. States that she is not taking as prescribed but she was too chicken to take the 10mg. States she will be back to see her doctor on 16Apr2021. States that she hates taking any medicine. Tests: States that she had bloodwork done Friday (02Apr2021) but has no idea of the results. States she will be seeing her doctor 16Apr2021 to go over the results. Vaccination facility type was Hospital drive up. Vaccine administered at military facility was No. No events required to ER. Caller states she has contacted her doctor to find out about her future vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 61 | 2021-04-24 | insomnia |
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada...
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felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
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| 61 | 2021-04-24 | irritability |
Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headach...
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Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; It is extremely irritating; Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; This is a spontaneous report from a contactable consumer (patient). This 61- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Mar2021 at 12:00 AM (at the age of 61-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was reported as "other" and anatomically located on the left arm. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EL9265,) dose 1 on 08Feb2021, for covid-19 immunization. No allergies to medications, food, or other products. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, she experienced Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing thou is still present 24/7. It is extremely irritating and there is nothing i can do to make it better. Treatment was not received for the adverse event. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.
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| 61 | 2021-04-26 | feeling abnormal |
when woke up today 4/27/21 at 7am, exhausted, muscle ache, headache, fever 101.3, foggy brain, 2 new...
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when woke up today 4/27/21 at 7am, exhausted, muscle ache, headache, fever 101.3, foggy brain, 2 new symptoms that I didn't get with first vaccine: VERY thirsty, bloodshot eyes
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| 61 | 2021-04-27 | confusional state |
Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, conf...
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Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, confusion, and malaise. Patient was admitted for hyperglycemia, suspected UTI and COVID-19 infection. Patient reported symptoms started around the same time of vaccination. Patient is still admitted at time of writing.
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| 61 | 2021-04-27 | insomnia |
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai...
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I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
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| 61 | 2021-04-28 | nightmare, insomnia, feeling abnormal |
First shot was fine - no symptoms. Second shot - severe flu type symptoms, headache, body aches, ch...
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First shot was fine - no symptoms. Second shot - severe flu type symptoms, headache, body aches, chills. Had trouble sleeping the following night of the vaccine with nightmares, unable to sleep at all, just plain felt miserable and had difficult time getting out of bed.
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| 61 | 2021-04-29 | amnesia |
Global amnesia. Husband took me to specialty hospital ER. Cat scan and exams done. Taken to their fa...
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Global amnesia. Husband took me to specialty hospital ER. Cat scan and exams done. Taken to their facility for observation, telemetry etc overnight
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| 61 | 2021-04-29 | anxiety |
Shortly after receiving the vaccine, Client complained of lightheadedness. She noticed it when she ...
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Shortly after receiving the vaccine, Client complained of lightheadedness. She noticed it when she started to get up to leave as she had sat there for 30 minutes. She does admit to having some anxiety about getting the shot as she has had an anaphylaxis reaction to both pyridium and macrobid requiring ED intervention. She carries an epipen with her. She is on Metoprolol as she throws quite a few PVCs. BP at 11:55 am 186/88- pulse-64 and ox reading 97%. Encouraged to drink some water to hydrate as has not drank much today. BP at 12:05 pm BP=184/84 and light headedness has resolved and able to leave. Card with contact information given to Client if any other side effect should be experienced. Encouraged her
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| 61 | 2021-04-29 | impaired work ability |
After my vaccine, I passed out. I went to the hospital for three days and they told me I had an ocul...
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After my vaccine, I passed out. I went to the hospital for three days and they told me I had an ocular migraine. I also had a post concussion syndrome and was out of work till 04-12-2021 with nausea and severe migraine headaches. I still have headaches today and I am on migraine medication.
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| 61 | 2021-04-29 | sleep disorder, feeling abnormal |
At 11:15 p.m. (10 hrs. after shot), I woke up nauseous, sat up in bed and felt weird, got up and mad...
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At 11:15 p.m. (10 hrs. after shot), I woke up nauseous, sat up in bed and felt weird, got up and made it to the foot of bed and passed out. When I came to, had my husband get me a cold rag, but then I felt diarrhea hit, I crawled to the hall to the bathroom, stood up and had the uncontrollable shakes so bad the whole toliet shook with me. After I finished in bathroom I went back to bed and literally shook for 1 1/2 hours and was up most of the night. This was my 2nd shot. On the 1st shot it made me feel like I was in a fog, like when you pass out and come to and your not all there. Took 3 hours to shake that one. I don't know what is in the freakin thing, but my body cant take this kind of stuff and I WILL NOT be doing any more of this quickly made, quickly approved vaccines. Count me out for any further ones. I'M DONE !!! I have never taken the flu shot ever so I WON'T be doing any more of these no matter how much the CDC pleads with me
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| 61 | 2021-04-29 | sleep disorder |
Patient received first dose of Pfizer Covid 19 vaccine on 03/12/21 in am and by 8pm same day, she wa...
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Patient received first dose of Pfizer Covid 19 vaccine on 03/12/21 in am and by 8pm same day, she was experiencing numbness and tingling in left arm, from acromian process to hand/fingers. She also report pain in arm, especially at night which wakens her. she is able to relieve the pain by stretching and extending left arm above her head. She has received second dose of Pfizer Covid 19 vaccine on 03/30/21 in right deltoid and has not experienced these symptoms. The symptoms reported in left upper extremity continue through today. 04/30/21.
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| 61 | 2021-04-30 | feeling abnormal |
severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakn...
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severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-05-07 | anxiety, feeling abnormal |
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac...
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Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
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| 61 | 2021-05-09 | feeling abnormal |
Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in lef...
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Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours
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| 61 | 2021-05-09 | loss of personal independence in daily activities |
Day after injection- diarrhea for two days and sore arm. Five days after injection left arm so sore ...
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Day after injection- diarrhea for two days and sore arm. Five days after injection left arm so sore I couldn't use it. Prescribed Motrin 600. Pain gone in two days.
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| 61 | 2021-05-10 | feeling abnormal |
bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue...
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bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
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| 61 | 2021-05-12 | nervousness, anxiety |
Client began to feel anxious and shaky after receiving the vaccine. Fire Rescue at the scene to eval...
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Client began to feel anxious and shaky after receiving the vaccine. Fire Rescue at the scene to evaluate client. Clients BP was elevated but all other vitals stable. Client states hx of high BP and did not take BP meds this morning. Client began to feel much better and blood pressure came down. Per Fire Rescue no further evaluation needed. Client exited park at 2:30pm.
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| 61 | 2021-05-14 | excessive sleepiness |
Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her ri...
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Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)
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| 61 | 2021-05-19 | feeling abnormal, amnesia |
TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and to...
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TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.
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| 61 | 2021-05-19 | sleep disorder |
Sunday after 2nd dose of vaccination (May 9) I started having numbness and tingling in my arms legs,...
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Sunday after 2nd dose of vaccination (May 9) I started having numbness and tingling in my arms legs, face and neck and experiencing nausea. When I sleep at night if I lay in one position for too long my day starts to burn in that area. I am having trouble sleeping. The nausea continues to come and go as does the numbness and tingling and burning issues at night. It seems to be getting worse every day and I am getting tired and weak.
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| 61 | 2021-05-21 | feeling abnormal |
itching; brain is on hold; localized injection site urticaria; generalized prickle sensation; Bilate...
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itching; brain is on hold; localized injection site urticaria; generalized prickle sensation; Bilateral Wheezing; hoarse voice; Generalized Urticaria; Generalized erythema; coughing so bad she vomited: first dose; broke out in a rash; croupy cough; rhinorrhea/runny nose; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm on 22Mar2021 08:00 (lot number EP7534) at single dose for COVID-19 immunisation. Medical history included Latex allergy, Penicillin allergy. Patient previously experienced allergies with allopurinol (ELAVIL) and amitriptyline. Concomitant medications included triamcinolone acetonide (KENALOG), famotidine (PEPCID), and multivitamins. Patient reported that when she first got her vaccine, she broke out in a rash on 23Mar2021, nothing productive, no fever no nothing. She took care of the rash with a little prednisone, antihistamines. She stated the day she got her first one was 22Mar2021. Her arm got red the next day 23Mar2021, nice little whelp around it, her arm started getting kind of bumpy and a little itchy, then she noticed it on her back and her chest then around her waist, just patches, whelps. She started on Hydrocortisone and it just never went away. Then after, started 29Mar2021 or 30Mar2021, she got a croupy cough, the coughing lasted a few weeks, it ended sometime in the end of Apr. She thought it was seasonal allergies, but the coughing was so bad she was actually vomiting from it. She stated she actually thought she had COVID but she didn't run a fever and didn't lose taste or smell, just the way she was coughing and it was in her chest. She stated just some coughing, no fever, no production of anything, just coughing, very raspy. She had a dose pack, she took it, took Benadryl, Antihistamines, the rash was still there, but not as bad. She states the first one stayed on her back and chest and a little bit on her arms, back, arms and so forth. Then the second shot (in her left arm, LOT: ER8732), she was head to toe in a rash and she got the second shot 12Apr2021 in the left arm at 08:00. The rash never even went away, it just got worse. She stated it was serious enough because of all the medication, Benadryl, antihistamines, Atarax. The patient also experienced runny nose in Mar2021. She stated it's like her brain is on hold since the shot. She stated the coughing so bad she vomited started the first of Apr. The cough had just gotten so hard, no matter what kind of cough medicine she took, it just did not help it. She stated flat out croupy cough. Cough Medicine: she just did the Mucinex DM for the congestion and she did Dayquil and Nyquil that type of thing. She stated when she got on the steriods, that did help with that. She stated she was on her fourth dose of steriods, oral steriods, she had one IM dose. She had to go to doctor to get an IM steriod and other three have been oral. The treatment medication included: Hydrocortisone (EXP: Nov2023, LOT: 20W319, NDC:0031713-03): Cortisone 10. It's the cream she's been using, the itch relief cream, to help relieve the itching. She's been using regular Hydrocortisone cream, she's used a lot of that. Prednisone (LOT: UJ200503B, EXP: Mar2022, NDC: 42806-400-21) pack currently on, she stated this is the third pack of tabs. Prednisone shot: she went to the doctor office and got a prednisone shot the week before last, so last Wednesday on 28Apr2021 or 29Apr2021. Two previous steroid packs. Benadryl (LOT: P83332, EXP: Jun2021): 25 mg tablets, takes two of them about every 3-4 hours. Loratadine (LOT: 0BE2611A, EXP: Oct2021, NDC: 49348-818-56): 10 mg tablets, she takes them first thing in the morning, by mouth. She stated it's been tough between taking magnesium sulfate (EPSOM) salt baths and avena sativa (OATMEAL) baths. Patient was not seen in the emergency department, no hospitalization required. Respiratory: Bilateral Wheezing, Dry cough, hoarse voice, rhinorrhea. Dermatological/Mucosal: Generalized Urticaria, Generalized erythema, generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticaria. Patient did not receive any recent vaccines for any other conditions prior to the event being reported, did not receive any recent vaccines for SARS-COV2 other than the Pfizer- BioNTech COVID-19 Vaccine prior to the event being reported, did not receive any other vaccines around the time of Pfizer- BioNTech COVID-19 Vaccine vaccination. Lab data included COVID test: unknown result on unspecified date. The outcome of event rash, itching was not recovered, outcome of cough, vomiting, rhinorrhoea was recovered in Apr2021, outcome of other events was unknown.; Sender's Comments: Based on information available, the reported serious event rash was likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to the temporal relationship and known safety profile of this product.
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| 61 | 2021-05-24 | feeling abnormal |
Patient has had Bells Palsy 2 times prior. 1976 H1N1 vaccine / 2009 after having been infected with...
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Patient has had Bells Palsy 2 times prior. 1976 H1N1 vaccine / 2009 after having been infected with H1N1. No Fever at all during 14 days May 12- facial pain, body aches, head aches. May 15- all symptoms continued facial swelling, loss of feeling to touch of face. Pain traveling down neck. Left side of face dropping. Hands very cold and cramping. May 17 - body aches and headaches leave. All other symptoms and facial pain continues. Tingling of skin on knees begins. May 21 - knees and thighs begin to feel numb and tingly. This feeling of not right continues to increase and spread. May 24 - all facial pain increased. Legs and arms tingly and numbing feeling unsteady. May 25- flushing and rash appears. Arms are heavy and all other symptoms continue.
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| 61 | 2021-05-26 | disturbance in attention, loss of personal independence in daily activities |
Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has...
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Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has become incontinent and now has to where a diaper, and leans to her right side while sitting and standing. She cannot focus for very long. And she becomes rigid and stiff for periods of time. She is no longer able to bath herself or care fir her basic needs. Even with intense therapy hasn?t reached her baseline.
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| 61 | 2021-05-26 | feeling abnormal |
severe brain fog; intense cramping; she got red really fast and almost a strange itching inside her ...
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severe brain fog; intense cramping; she got red really fast and almost a strange itching inside her body; felt she had Covid; Mild diarrhea; body aches; fever; Headaches; This is a spontaneous report received via medical information from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8737) at the age of 61-year-old, as single dose for covid-19 immunisation. Medical history included ongoing thyroid disorder has had for years, ongoing hypertension started about 8 years ago, ongoing immune system disorder ( Her spleen has been removed, and she is immune compromised). The patient was immune compromised and has no spleen and she had Covid and has Covid long haulers. The patient's concomitant medications were not reported. The patient received the second dose of Covid vaccine received on 20Apr2021, at 09:00, right arm injection. After the 1st dose of Covid vaccine she felt she had Covid. Mild Covid again, for about 4 days. She experienced fever, body aches, and some mild diarrhea the same day of vaccination. The patient did not confirm if she just felt like she had Covid again or tested positive for COVID-19 after first dose. She had diarrhea until she received the second dose of the vaccine then got ulcers in her mouth, body swelling, and had headaches with both doses. The patient stated that fever started after the 1st shot, within 4 hours, It was fast. She was sitting with a friend and she got red really fast and almost a strange itching inside her body. She told her friend she needed to lie down. Her friend told her she didn't look good. It happened so quick. It started on 30Mar2021 and she recovered completely. Body aches started on 30Mar2021 but not until the evening and lasted until it ended with the fever. She recovered completely. She was a long hauler and this was a whole different ball of wax. Patientdidn't feel it when she had Covid. Mild diarrhea started in the middle of the night on 30Mar2021 and she doesn't think it ever ended. It spun around, It was now constant diarrhea and continues from the first dose. It waswater and with intense cramping and is constant. She is on the BRAT diet. It won't hold so she is living on Gatorade and white rice. Headache started with the first dose. The headache came in after the first dose and was very mild. It left just like the symptoms did. The headache started when the fever started and it started quickly and it hasn't left. Patient also complained severe brain fog. The patient experienced felt she had covid (suspected covid-19) on 30Mar2021 with outcome of unknown, mild diarrhea on 30Mar2021 with outcome of unknown , body aches on 30Mar2021 with outcome of recovered , fever (non-serious) on 30Mar2021 with outcome of unknown , headaches on an unspecified date with outcome of unknown, severe brain fog (feeling abnormal) on an unspecified date with outcome of not recovered , pruritus on 30Mar2021 with outcome of recovered , intense cramping on an unspecified date with outcome of unknown.
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| 61 | 2021-05-26 | insomnia |
Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left a...
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Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown. No follow-up attempts are needed. No further information is expected
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| 61 | 2021-05-27 | feeling abnormal |
body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog;...
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body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-06-02 | anxiety |
Pt reported severe anxiety and syncope when receiving injectable medication and blood draws. Pt was ...
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Pt reported severe anxiety and syncope when receiving injectable medication and blood draws. Pt was agreeable to receive vaccine and a plan was made ahead of time to administer to her in her vehicle with the seat laid flat. Upon receiving the vaccine, the pt immediately stated, " I don't feel good" and began to hyperventilate and complaint of tingling in all extremities. Pt then vomited and an EMS crew on standby was notified to evaluate the patient. The patient was eventually transported to the ER due to near syncope and hypotension.
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| 61 | 2021-06-03 | restlessness |
Began to feel hot.; Upper extremities became to feel tingly or prickly internally/ tingling traveled...
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Began to feel hot.; Upper extremities became to feel tingly or prickly internally/ tingling traveled to my legs; Antsy, fidgety and felt like bouncing off the walls.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in left arm on 16Mar2021 at 07:15 (at an age of 61-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 16Mar2021 at 07:30, approximately 10 minutes after the vaccination the patient had upper extremities felt tingly or prickly internally and began to feel hot. Then the tingling travelled to his legs, almost like the feeling when legs fall asleep. About an hour later felt like drank a pot of coffee, the patient was antsy, fidgety and felt like was bouncing off the walls. The clinical outcome of upper extremities felt tingly or prickly internally and began to feel hot, tingling travelled to the legs, almost like the feeling when legs fall asleep was recovered on an unknown date; while for the event antsy, fidgety and felt like was bouncing off the walls were recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-06-03 | sleep disorder |
Cough; Body aches; I am tired because I have been sleeping a lot; Injection site pain; Chills; I am ...
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Cough; Body aches; I am tired because I have been sleeping a lot; Injection site pain; Chills; I am tired because all I do I have been sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via an unspecified route of administration on 29May2021 in upper right arm as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30May2021, the patient experienced cough, some body aches, she was tired, she got the pain at the injection site which she knew was common anyway, little bit of chills but nothing major. She was tired because all she did was sleeping a lot. She just wanted to know if she could take amphetamines (treatment), if it could help alleviate some of those side effects. She wanted to know if it was safe to do that or not. The outcome of all events was unknown. Consumer was informed about Pfizer Medical Information Department. Information on Lot/Batch number was available. Additional information has been requested.
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| 61 | 2021-06-06 | sleep disorder |
Around 7:00-8:00 that evening, approximately four hours after recieving the vaccine, I started havi...
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Around 7:00-8:00 that evening, approximately four hours after recieving the vaccine, I started having shooting pain in my head. It was mild at first, then harder and more frequent as the evening went on. It did that until late the next morning and was completely gone by around noon. This wasn't a 'headache' or migraine. It was shooting pain like none I had ever had in my head. I had a knee revision years ago and it also affected the knee through the night with that same type of pain. I wasn't as concerned about the knee, but, the head was concerning. I didn't report it because I didn't know I had to register to check in.
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| 61 | 2021-06-07 | anxiety |
She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymp...
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She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymph nodes in right leg; This is a spontaneous report from a contactable consumer(Patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 as 2nd DOSE, Single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. No family medical history reported. The patient's concomitant medications were not reported. Patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm left on 02May2021 as single dose for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. It was reported that, on 26May2021, after getting the second dose of the Covid vaccine, she had swollen lymph nodes in her right leg. She was worried and asks what to do and She asked if she needs to go to Urgent Care. she is worried it is a kind of blood clot. She asks if Pfizer will call her doctor and then call her. All she had were swollen lymph nodes. They are getting big and big. She confirms they are getting bigger. No relevant tests reported. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 61 | 2021-06-07 | depression |
feeling very very low and depressed and moody/ sadness, not myself/ events worsened yesterday its se...
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feeling very very low and depressed and moody/ sadness, not myself/ events worsened yesterday its seems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on the left arm on an unspecified date (at the age of 61-years-old) as second dose, single dose for COVID-19 immunization. Medical history included ongoing depression (that was reported as currently and have this for several years on medication). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN SR), quetiapine, atorvastatin (LIPITOR), amlodipine, levothyroxine sodium (SYNTHROID) and hydrochlorothiazide; all taken for an unspecified indication, start and stop dates were not reported. On an unspecified date in 2021 (reported as Saturday, yesterday), the patient experienced feeling very very low, depressed, moody, sadness and not herself. The events were reported as seemed to have worsened. The patient was not sure if the events were reaction to the second vaccine she had on Thursday and stated that it may be the vaccine was effecting. The event seriousness was unspecified by the reporter. There was no investigation assessment. No treatment was given as a result of the events. The outcome of the event was not recovered. The patient was querying if this could be experienced by the medication that she was taking. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 61 | 2021-06-07 | impaired work ability |
he received Pfizer vaccine 2/5 and got symptoms a few weeks after the vaccine. She experienced a lo...
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he received Pfizer vaccine 2/5 and got symptoms a few weeks after the vaccine. She experienced a lot of chest pain at work and went to healthcare facility and was diagnosed with pleurisy. She received steroid treatment and a steroid shot and then received another 3 rounds of steroids - this was through February, March, and April. She saw a pulmonologist 5/20 and CT scan done again and CXR. She was diagnosed with pulmonary edema and elevated calcium levels. She was started on some pain medicine at that time and a steroid. After she came off steroids, was in a lot of pain and had to stop working. Diagnosed with recurrent pericarditis.
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| 61 | 2021-06-07 | memory impairment |
Stomach cramps increased; Upset stomach; Memory is not good/sometimes she remember things that amaze...
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Stomach cramps increased; Upset stomach; Memory is not good/sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday; Pain in lower abdomen; This is a spontaneous report from a contactable consumer (patient) and physician. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 12:00 as 2nd dose, single dose for COVID-19 immunization; palbociclib (IBRANCE), via an unspecified route of administration from Apr2016 (Batch/Lot number was not reported) to 27May2021, at 125mg caplets oral with water for 21 days on and seven days off once a day for stage IV metastatic breast cancer. The patient's medical history and concomitant medications were not reported. No patient history. Family Medical History Relevant to AE(s): None. No other products. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date 12:05 as 1st dose, single dose for COVID-19 immunization and had stomach cramps. The patient stated that she was on Ibrance. The patient stated that she had second shot on 29Apr2021. Since the second vaccine, she had so much trouble with her stomach. The patient stated that this had been an ongoing thing. Her stomach cramps increased, and she had pain in her lower abdomen. The patient stated that she had the first shot three weeks before the second shot and had stomach cramps. The patient stated that stomach would not settle down. The patient stated that she would get some good days. The patient stated that last week on Thursday that she was in downward spiral and could not get out of it. The patient stated that she was being careful with what she ate. The patient stated that she stopped the Ibrance. The patient stated that this week was her seven days off and she would call today to ask for next month but wanted to take a reduced amount. The patient stated that when she saw her oncologist that she asked if people ever stop taking Ibrance and was told no that if one has a reoccurrence that it may not work as well. The patient stated that she did not ask for a reduction at that time but intends to. It was a temporary stop. The patient stated that this was more about Ibrance than the vaccine. The patient stated that she had pain in lower abdomen that started 10 days ago. The patient stated that she gets upset stomach from time to time but that it had been pretty constant since the first week in May. The patient stated that sometimes she remembers things that amazes her and sometimes she cannot remember what happened yesterday. The patient stated that other factors were involved (memory) at that time that her husband was ill. The patient stated that the stomach cramps started again 6 days after second vaccination and resolved last week. Recovered with lasting effects of upset stomach. The patient stated that she changed from capsules to caplets in 2020. The patient was treated with Mylanta. The patient stated that she had a video call scheduled with her nurse practitioner. Is eating soft foods and keeps drinking water. Relevant Tests: None. The event did not result in Emergency Room/Physician Office. The outcome of the events stomach cramps increased was recovered with sequelae, pain in lower abdomen, upset stomach was recovered, memory is not good/sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday was unknown. Follow-up attempts are possible. Further information is expected.
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| 61 | 2021-06-08 | poor quality sleep |
Pt received first Pfizer COVID vaccine dose at approximately 0800 on 5/27/2021. Injection administe...
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Pt received first Pfizer COVID vaccine dose at approximately 0800 on 5/27/2021. Injection administered in left deltoid. Pt states that she took two Tylenol before going to bed the night of 5/27/2021. Felt fine prior to going to bed except for injection site pain. She was awakened by chest pain, muscles pain, joint pain and swelling and malaise at 0200 on 05/28/2021. She states she did not have a fever and felt cold but no chills. States the chest pain lasted about 30 minutes. Unable and afraid to go back to sleep after this episode. Joint and muscle pain resolved after about 2 days.
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| 61 | 2021-06-09 | feeling abnormal, depressed mood |
flushing on my face three times like heated /top of my head to chin and is like some covered it but ...
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flushing on my face three times like heated /top of my head to chin and is like some covered it but it was more like flush; felt little bit weird; Heart racing; felt little off; head is drawling; hives; This is a spontaneous report from a contactable consumer. A 61-years-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EN6206; expiry date, UPC number and NDC number were reported as unknown) via an unspecified route of administration on 20Mar2021 in left arm as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On 20Mar2021, the patient experienced slight reaction in morning after 10 mins of first shot which included flushing on face like three times and it was heated (from top of head to chin and was like some covered it). Her doctor said flushing was like something that drained out of her face like heat. She was not able to describe it. 15 mins after taking the shot she felt little off and weird, had hives, her heart was raising (doctor couldn't recognize her pulse), and her head was drawling. The events occurred 2 to 3 times in a row. She stayed at the vaccination centre for 30 minutes and after that she felt fine. She reported that she had little diet and too much caffeine half the day, received first dose and had mild reactions but was fine after an hour. She asked if she could take second dose and does the events get worse after second dose. The patient did not receive any treatment. The action taken in response to the event for BNT162B2 was unknown. The outcome of all the events was recovered on 20Mar2021. No follow-up attempts are possible. No further information is expected.
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| 61 | 2021-06-09 | feeling abnormal |
Feeling some nausea almost daily. Feel like marbles are between my skin (like on my foot, hand, un...
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Feeling some nausea almost daily. Feel like marbles are between my skin (like on my foot, hand, underarm, head) but cannot feel them it just feel like something is there. High allergic reaction to my cat. (have had my cat for 6 years, now got hives). Just overall not feeling well. Feel itchy like I'm about to have a reaction. Like heightened response to allergens.
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| 62 | 2021-01-04 | excessive sleepiness |
Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue....
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Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue. Slept most of the day. Took acetaminophen when able to drink. Drank ginger tea and ate dry toast in the evening. Tuesday, HA controlled with Acetaminophen and Ibuprofen. Able to eat and increase fluids. Consulted with my PCP who suggested I enter my information. Feeling stronger as time passes. I believe another nights sleep will help.
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| 62 | 2021-01-05 | anxiety |
swelling and joint pain in the little finger on left arm; swelling and joint pain in the little fing...
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swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-07 | confusional state |
At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe bod...
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At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe body aches for an hour. 18 hrs after injection was mild-moderate headache and moderate tiredness and confusion for another 4-6 hrs.
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| 62 | 2021-01-07 | sleep disorder |
My body had started itching and I didn't know why. I had not eaten anything new or changed any sha...
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My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.
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| 62 | 2021-01-08 | confusional state |
Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially....
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Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.
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| 62 | 2021-01-10 | impaired work ability, feeling abnormal |
shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever...
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shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-01-11 | anxiety |
Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat a...
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Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat and tonsils. Patient did sip water and was verbally communicative and was texting on phone with pale, anxious appearance with not obvious shortness of breath noted. 911 was called to Center per vaccine clinic protocol at which ems initiated IV and took patient to ED.
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| 62 | 2021-01-11 | disturbance in attention, feeling abnormal, excessive sleepiness |
Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any att...
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Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-11 | fear, amnesia |
some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was real...
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some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
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| 62 | 2021-01-11 | feeling abnormal |
20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of so...
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20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.
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| 62 | 2021-01-11 | sleep disorder |
approximately 2 hours after my vaccination, I started with a very severe headache and felt extremel...
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approximately 2 hours after my vaccination, I started with a very severe headache and felt extremely tired. I had difficulty staying awake. I slept about 2 hours. When I woke up my headache was gone and I was no longer tired. I went to bed and slept well until a headache woke me up the next morning however it was not as severe as the previous night. I was a bit lethargic but not too bad. My headache continued until the evening of 1.11.21 however I was not lethargic and was able to work. Today is 11.12.21 and I feel fine. I had no injection site discomfort to speak of.
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| 62 | 2021-01-12 | anxiety | Dizziness, Headache, Palpitations, HYPERtension, anxiety and stated SOB Narrative: |
| 62 | 2021-01-13 | impaired work ability | I had to leave work as I was achy, fatigued and had a headache |
| 62 | 2021-01-13 | nervousness, feeling abnormal, fear |
was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was f...
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was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.
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| 62 | 2021-01-14 | feeling abnormal, sleep disorder |
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ...
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Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
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| 62 | 2021-01-14 | impaired work ability |
On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Ca...
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On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Called off of work.
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| 62 | 2021-01-15 | impaired work ability, excessive sleepiness |
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = ...
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Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.
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| 62 | 2021-01-17 | anxiety |
Patient experience heart palpitations and was experiencing anxiety before and during vaccination. Af...
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Patient experience heart palpitations and was experiencing anxiety before and during vaccination. After sitting for 30 minutes after getting the vaccine patient felt more calm.
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| 62 | 2021-01-19 | impaired work ability |
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ...
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Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
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| 62 | 2021-01-20 | nervousness |
Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at E...
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Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy". She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time. Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time. Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension
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| 62 | 2021-01-21 | impaired work ability |
Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately...
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Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately 36 of those hours
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| 62 | 2021-01-21 | loss of personal independence in daily activities, sleep disorder |
A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm t...
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A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.
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| 62 | 2021-01-22 | insomnia | Insomnia, body aches, chills, low grade fever. I was okay by noon on Thursday. |
| 62 | 2021-01-24 | feeling abnormal |
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ...
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Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
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| 62 | 2021-01-24 | loss of personal independence in daily activities |
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm...
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joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.
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| 62 | 2021-01-25 | confusional state | ON 1/20/21 DEVELOPED FATIGUE, CONFUSION, AND VOMITING. FOLLOWED UP WITH PCP. |
| 62 | 2021-01-26 | anxiety, agitation |
Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVI...
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Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVID dose #1 at staff COVID vaccination clinic - waited 15 minute observation then returned to workstation. About 20 minutes after vaccination began experiencing light headedness, anxiousness, agitation and heart racing. Symptoms increased over next 1-2 days then diminished over the following week. Did not report symptoms. Stated "feeling like myself now"
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| 62 | 2021-01-27 | feeling abnormal |
migraines; arm is sore where the injection; she could hear like blood going through her, and if she ...
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migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.
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| 62 | 2021-01-29 | feeling drunk |
Felt woozy like; felt like she's drunk. Pt denies tightness in chest, jaw pain or heaviness in ches...
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Felt woozy like; felt like she's drunk. Pt denies tightness in chest, jaw pain or heaviness in chest. Treatment: Rest and water also referred to primary care clinic as she refused to go to the emergency room for further care. The pt was able to walk without assistance and stated she was fine.
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| 62 | 2021-01-31 | nervousness, feeling abnormal |
(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point...
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(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.
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| 62 | 2021-01-31 | nightmare |
On the day following the vaccination, I had fever 100.3 and when I took a nap in the afternoon I had...
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On the day following the vaccination, I had fever 100.3 and when I took a nap in the afternoon I had nightmares and had difficulty waking up. It felt as though I had been drugged.
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| 62 | 2021-02-01 | impaired work ability |
Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection s...
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Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.
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| 62 | 2021-02-03 | insomnia |
chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weaknes...
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chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 62 | 2021-02-03 | mental status changes, hallucination | PER MD: HIGH FEVER, TACHYCARDIA, HALUCINATIONS, CHANGE IN MENTAL STATUS |
| 62 | 2021-02-04 | confusional state |
My blood pressure shoots up really high; My upper body got red like tomato; I was really like confus...
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My blood pressure shoots up really high; My upper body got red like tomato; I was really like confused for several hours; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at left shoulder on an unspecified date at single dose for COVID-19 immunization. The patient medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient reported that: "my reaction was my blood pressure shoots up really high and my upper body got red like tomato and I was really like confused and 'spacing' for several hours". The patient did not receive any treatment. The patient outcome of the events was unknown.
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| 62 | 2021-02-05 | feeling abnormal | Fever x 3 days Weakness, fatigued, achy Urinary Incontinence day 1 Brain fog |
| 62 | 2021-02-07 | insomnia |
Started to have weird body weakness sensation associated with mild nausea when I lay down at night. ...
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Started to have weird body weakness sensation associated with mild nausea when I lay down at night. Almost every night. As soon as I lay flat. Comes in waves. Causing me having problems falling asleep. Also happens when I tried to fall back to sleep. Mostly when I am about to fall asleep. During the day I am ok if I am upright. No fever or other symptoms. Getting insomnia from it every night.
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| 62 | 2021-02-07 | mental impairment |
I had difficulty forming thoughts and speaking in more than a few words at a time. I was aware I was...
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I had difficulty forming thoughts and speaking in more than a few words at a time. I was aware I was trying to think or respond, but felt somehow blocked from access and ability to think and speak. This experience lasted for about 28 hours, and then my access to cognition returned. By the way, I am a doctoral level psychologist for whom these skills are typically easy.
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| 62 | 2021-02-08 | loss of personal independence in daily activities |
On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started ...
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On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started to used my inhalers and it would give some relief but I was using it more than normal. I had not had asthma attack for more than a year. My asthma is very controlled that I don't use any inhalers whether daily or as needed. I went to work as usual since at that time my symptoms weren't getting worse but also not getting better. On 1/19/21, I was feeling more out of breath and having more dry hacking cough that when I called EH I was told to do the Covid testing. That same day I called my Asthma doctor and did a video call and was prescribed Breo inhaler, spiriva inhaler, xoponex nebulizer treatment and xoponex rescue inhaler. I couldn't go to work because of my shortness of breath and coughing. The treatment didn't work. On Tuesday 1/26/21, I called my asthma doctor again and another video call was made. She changed my inhaler to symbicort, still continue spirirva inhaler and nebulizer treatment. I also contacted my primary doctor who asked that I schedule an appointment with him so he can see me. On 1/28/21, I saw my primary doctor who did blood works to see if I have any blood clot and to see how my heart was doing. I was given phenergan with codeine to help with my coughing and it did help me to go to sleep. My blood works came out negative and he ordered CAT scan of my chest since I can't get rid of my SOB and coughing. I had the CAT scan on 2/3/21. He called me the next day and I was told that I had mucous plugging. He told me to go home and he prescribed Duoneb nebulizer treatment 4x a day and spiriva inhalers 2x a day. I started to get rid of the mucous that I had and started to breath better. It took 4 days of 4x a day nebulizer treatment and inhalers before I started to feel
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| 62 | 2021-02-10 | feeling abnormal |
woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and ha...
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woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.
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| 62 | 2021-02-10 | sleep disorder |
collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and s...
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collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
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| 62 | 2021-02-12 | feeling abnormal, sleep disorder |
The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little...
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The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little. I was chilling so badly that I couldn't get to sleep! When I got out of bed in the morning, I could barely move due to severe muscle pain. I did very little all day, suffering from what felt like the flu: chills, loss of appetite, and "brain fog" such that I couldn't read or think clearly. My head felt warm, but I never took my temperature. The next morning, I noticed hives on my chest between my breasts and around the armpit of my left arm. The following morning, now about 45 hours after my second injection, I still had pink hives, and my left armpit was swollen so that it wasn't concave, as it always is, but convex. Touching my armpit hurt, and I think some gland in it was swollen. Similarly, a gland on the left side of my neck was swollen and painful to the touch. Today, now the fourth day since the injection, the hives have subsided, and my glands are almost back to normal. Overall, I am very glad to have had the opportunity to get the vaccine, but I haven't felt that sick in years.
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| 62 | 2021-02-14 | loss of personal independence in daily activities |
01/07/2021 Started having low back pain on right low back took Advil on the 01/08/2021 horrible pain...
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01/07/2021 Started having low back pain on right low back took Advil on the 01/08/2021 horrible pain the radiates around pelvic area and across the whole lower back, called off work and went it to Physician in the afternoon. Examined for Muscular Cellular was prescribe Flexeril 10mg once a day at bedtime, Naproxen 500mg twice a day. Took them about three days was able to go back to work.
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| 62 | 2021-02-15 | anxiety | Pt reports heart racing, anxiety, and a flushed feeling with onset at 1800 |
| 62 | 2021-02-16 | impaired work ability |
Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work o...
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Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work on 1/27/2021. 8 hrs.
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| 62 | 2021-02-16 | impaired work ability |
Patient came to site for scheduled appointment to receive 2nd dose of Pfizer Covid. States she woul...
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Patient came to site for scheduled appointment to receive 2nd dose of Pfizer Covid. States she would like to reschedule because she was not feeling well. Reports she has not felt well since the first dose. States initially she felt dizzy and had a headache - the symptoms progressed to dizziness, headache unable to be relieved by medication, stomach pain and nausea. States she has consulted with PCP and lab tests will be ordered, she anticipates she will receive an order for a MRI of the brain. She also stated because of her symptoms she was considered by her work as a presumptive positive for Covid and was required to complete three Covid tests - all were negative. Encouraged patient to continue consulting with PCP and possibly an allergist. She will reschedule when she is feeling better.
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| 62 | 2021-02-17 | memory impairment |
The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperatu...
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The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 62 | 2021-02-19 | impaired work ability, excessive sleepiness |
About hrs after receiving injection- bad headache started - same as with the first injection. Not de...
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About hrs after receiving injection- bad headache started - same as with the first injection. Not debilitating. Then extreme fatigue started, some minor dizziness. Not debilitating. I work in a cardiology office. Administrator advised me not to come in. Ended up sleeping for most of the next 18 hrs. No nausea, no elevated temp. Just unbelievable fatigue.
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| 62 | 2021-02-21 | feeling abnormal |
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Calle...
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01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
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| 62 | 2021-02-23 | mental status changes |
2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admit...
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2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admitted to hospital; Dx: HSV-1, Encephalitis; Tx: Acyclovir IV TID x 3 weeks, completes tx on 2/25/21 Admitted total of 6 days 2/10/21: discharged home, continues to have difficulty with computation of numbers and naming objects
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| 62 | 2021-02-24 | confusional state | low grade fever first 2 days, continued off and on nausea, dizziness and confusion |
| 62 | 2021-02-28 | feeling abnormal |
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar...
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Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
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| 62 | 2021-02-28 | nightmare |
nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patien...
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nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patient). A 62-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8292), via an unspecified route of administration in the right arm on 27Jan2021 07:15 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) on 09Jan2021 04:45 PM in the left arm for covid-19 immunisation. The patient experienced nightmares and difficulty waking up on 28Jan2021 14:00 with outcome of recovered in 2021. This was very unusual for patient. Events assessed as non-serious. No treatment was received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications that patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
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| 62 | 2021-02-28 | sleep disorder |
mild headache at waking up and during the day on and off sweats on and off chills on and off feelin...
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mild headache at waking up and during the day on and off sweats on and off chills on and off feeling unwell as if I will get a flu or heavy cold
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| 62 | 2021-03-01 | anxiety |
PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of ele...
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PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of elevated blood pressure. Pt reported not eating anything all day except for two oranges. Pt reported feeling the room was "spinning". Pt given snack of granola bar, then rice crispies, and finished a juice box and a small water bottle. Pt was able to ambulate unassisted to bathroom at 1545. Pt called her husband to pick her up, and pt left with husband at 1555. Pt denied symptoms at that time.
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| 62 | 2021-03-03 | depressed mood, confusional state, anxiety, amnesia, insomnia |
Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm coul...
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Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
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| 62 | 2021-03-04 | feeling abnormal |
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day...
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I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
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| 62 | 2021-03-05 | anxiety |
Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, place...
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Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, placed on cot, feet up, with OS symptoms improved as did blood pressure
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| 62 | 2021-03-05 | disorientation, confusional state |
15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card,...
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15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.
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| 62 | 2021-03-08 | feeling abnormal |
Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of...
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Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours
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| 62 | 2021-03-09 | feeling abnormal |
Patient received vaccination at pharmacy and then went to office in back of store to work. received ...
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Patient received vaccination at pharmacy and then went to office in back of store to work. received call from back about 1 hour later stated patient was feeling unusual. Went to back of store and checked patient. Patients blood pressure was elevated at 180/100. Patient temperature was normal. Discussed with patient and she decided that she would like to go to clinic to be checked
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| 62 | 2021-03-10 | insomnia | extreme bone pain, diarrhea, insomnia |
| 62 | 2021-03-10 | insomnia |
Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose dischar...
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Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.
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| 62 | 2021-03-10 | sleep disorder |
Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became li...
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Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.
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| 62 | 2021-03-11 | impaired work ability |
Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees an...
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Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.
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| 62 | 2021-03-13 | impaired work ability |
After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morni...
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After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender
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| 62 | 2021-03-13 | nightmare, fear |
The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain w...
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The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.
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| 62 | 2021-03-14 | feeling abnormal, confusional state |
Confusion, Headache, Sedation, Myalgia, Arthralgia & Fever Narrative: Employee c/o H.A., muscle,bone...
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Confusion, Headache, Sedation, Myalgia, Arthralgia & Fever Narrative: Employee c/o H.A., muscle,bone pain and aches, fever, chills, loss of energy, foggy brain.
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| 62 | 2021-03-14 | feeling abnormal |
Patient developed typical viral type symptoms ( felt foggy and "off") Saturday evening and woke over...
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Patient developed typical viral type symptoms ( felt foggy and "off") Saturday evening and woke overnight into Sunday with severe itching which lasted all day Sunday despite Benadryl and Pepcid and lotion. I saw patient Monday morning and she had hives on back, abdomen, arms, and some starting on legs. Given extent of hives, we administered IM steroid and prescribed Medrol Dosepak. No airway involvement. No prior history of reactions to vaccines. Will not know how effective steroids are as this is an urgent care, but she was feeling some improvement after sitting for 10 minutes after the steroid injection.
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| 62 | 2021-03-14 | impaired work ability |
A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my ...
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A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my forehead. I stayed home from work the next day and my fever was 100.0. Tylenol helped. I felt tired but better. It became difficult to breath. It felt like I had chest pains especially on exertion. It improved if I sat down. It lasted aa week. My doctor sent me for a chest x-ray and blood tests. I had contracted Covid-19 on the third week after my first dose of the vaccine. Positive test results on 01/11/2021.
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| 62 | 2021-03-14 | insomnia, feeling abnormal |
Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of sk...
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Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.
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| 62 | 2021-03-14 | sensation of foreign body |
she felt something in her foot (right foot) under the toes like she had sept on something like the l...
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she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.
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| 62 | 2021-03-15 | restlessness |
Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting...
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Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.
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| 62 | 2021-03-17 | feeling abnormal | Chills, dizziness, brain fog, headache |
| 62 | 2021-03-18 | anxiety, feeling abnormal |
I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper a...
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I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.
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| 62 | 2021-03-19 | sleep disorder |
My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the wa...
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My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the way down to my hand at time. My armpit is swollen and painful. The pain goes thru my underarm down to my hand. The pain makes it difficult to sleep. Tylenol doesn't take the pain away. At first I thought the pain was a side effect to the initial vaccine, but it got worse as time went on. Finally I researched it on line and saw that lymph nodes have been reported as swelling due to the vaccine.
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| 62 | 2021-03-20 | feeling abnormal |
Dizziness, feeling disconnected, off. Happened immediately. Felt better the next day but have had t...
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Dizziness, feeling disconnected, off. Happened immediately. Felt better the next day but have had the same feeling since the 3rd day. This is day seven.
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| 62 | 2021-03-21 | feeling abnormal |
high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog...
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high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog x 4 days , injection site reaction - swelling and redness in entire L arm x 3 days, hot flashes with intense sweating.
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| 62 | 2021-03-22 | disturbance in attention, anxiety |
3/20/21: Sudden fatigue, body aches, malaise, sweating lasting throughout the day. 3/21/21 previous...
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3/20/21: Sudden fatigue, body aches, malaise, sweating lasting throughout the day. 3/21/21 previous day's symptoms improved with some lingering fatigue but increasing manic symptoms, including perseveration, inability to focus, paranoia, manic anxiety, inability to make decisions, racing thoughts lasting throughout the day but clearing by the morning of 3/22/21. SYMPTOMS VERY SIMILAR TO ADVERSE REACTION TO CANNABIS
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| 62 | 2021-03-22 | sleep disorder |
Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swellin...
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Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care. Chest really hurting feeling dizzy face eyes swelling throat lump getting larger. My breathing rate normal , blood pressure normal , oxygen normal. They took me back gave me epinephrine and depo modral shot in right buttock cheek. After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up 36 hours drank water . Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.
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| 62 | 2021-03-23 | anxiety |
I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer ...
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I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.
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| 62 | 2021-03-24 | anxiety |
3/25/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ...
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3/25/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Anxiety . Assessment : Time of assessment 1200. Alert and oriented. Actions taken: Bp- 139/83. P- 77, O2- 100% Medications administered: none Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/25/2021 11:45 AM 0.3 mL 12/11/2020 Intramuscular
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| 62 | 2021-03-24 | excessive sleepiness |
I was VERY T ...
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I was VERY T i ???????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ?? ?? ?? SORRY about the above I'm not sure what happen tried to delete it but couldn't! I woke up Sunday 14th at 7:30AM feeling really tired. had coffee & could barely stay awake. by 8:30AM I went back to bed woke up 11AM ish had lunch could hardly keep my eyes open went back to bed & slept the afternoon away. got up 5PM ish had coffee & supper still very tired I went back to bed. woke up around 10AM had something to drink & bathroom then went back to bed & slept to morning. On Monday the 15th. & Tuesday the 16th. was pretty much the same as the 14th. On the 17th. woke up at 8:45AM FEELING GREAT! No other problem but being very tired!
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| 62 | 2021-03-25 | excessive sleepiness |
Ever so slight tingle in tongue within 30 mins with difficulty moving legs. Arrived home and slept ...
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Ever so slight tingle in tongue within 30 mins with difficulty moving legs. Arrived home and slept 5 hours. Spouse woke me up to eat. I was polite and took a few bites. Went to bed @ 10 pm. The next morning I woke in the fetal position and COULD NOT MOVE! Called husband for help. He lifted me to the sit up position by my rib cage. Very difficult to move for 4 days. Had Gammagard treatment on March 16. 2021. That was a mistake, I guess. I could not even think clearly enough to try to fill out this form.
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| 62 | 2021-03-25 | sleep disorder |
Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to ...
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Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to be lessening now
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| 62 | 2021-03-26 | anxiety |
Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pr...
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Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure
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| 62 | 2021-03-26 | restlessness |
Once I?d gone to bed on 3/25 about 10:30 pm. I woke up later that night feeling uncomfortable and re...
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Once I?d gone to bed on 3/25 about 10:30 pm. I woke up later that night feeling uncomfortable and restless. Had cold chills and headache when I woke up the next day I was extremely tired and felt like I had flu like symptoms The following day(Saturday) I felt like normal again myself again
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| 62 | 2021-03-27 | anxiety |
3/28/2021 (patient) was observed post Covid-19 immunization for 30 minutes based on pre-vaccinatio...
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3/28/2021 (patient) was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Hot, jittery. Assessment : Time of assessment 1332 Alert and oriented. And anxious Actions taken: VS taken at 1332, BP- 199/147, P- 123, O2- 100%,placed on stretcher, offered water and drinking, patient reports that she took her BP meds late today, VS recheck at 1344- BP- 182/73, P- 90, O2- 100%, symptoms residing, daughter in room. 1350 BP- 175/72. P- 89, O2- 100%, at 1400, BP- 174/89, P- 64, discharge with daughter at 1402. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 1:27 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8733
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| 62 | 2021-03-27 | feeling abnormal |
1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. ...
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1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. on 3/26/21. Woke up the next morning at 4:00 a.m. with pain in my arm and basically feeling terrible. I had pain in the arm, soreness under arm, achy and severe joint pain all over, headache over my eyes, extreme fatigue, chills on and off, a few instances of sweating, Generally felt really sick. Appetite decreased. The next night woke up in the middle of the night sweating, then later in the night with chills. Aching and pain in joints was miserable. By noon on 3/28/21 was feeling a lot better, still tired and arm just sore. Stomach still a little off.
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| 62 | 2021-03-28 | depression, sleep disorder, impaired work ability |
Initial reaction was extreme exhaustion. Wake up after about 5 1/2 hours with migraine-like headach...
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Initial reaction was extreme exhaustion. Wake up after about 5 1/2 hours with migraine-like headache. I took 2 Advil, when normal dose is 1, for me. I have been taking an average of 3 Advil every day since the vaccine because of the pain from the headache. I would guess last time I had to take Tylenol or Advil for pain was about September or October, 2019.. Depression is beginning to take hold, likely because of the headache; it has become very hard to work and concentrate. External body temperature is measured most days and it is only running about 97.8-98 F. Before vaccine, usual temperature was about 97.3-97.7. (We have a body temperature scanner at work due to the pandemic.)
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| 62 | 2021-03-29 | excessive sleepiness |
Woke up with severe vertigo. Could not walk, threw up several times in the course of six hours. Slep...
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Woke up with severe vertigo. Could not walk, threw up several times in the course of six hours. Slept most of the afternoon, but was very nauseous could not stand up all day. In the evening started feeling slightly better and could walk to the bathroom unassisted.
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| 62 | 2021-03-30 | impaired work ability, insomnia |
After taking the vaccine, that evening my breathing worsened and I also had a gout flare-up. The go...
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After taking the vaccine, that evening my breathing worsened and I also had a gout flare-up. The gout pain was so intense even after taking two pain pills, it kept me up all night. I was unable to report to work the next day and had difficulty walking for the next 3-4 days and breathing for the next week. I was even getting up 2-3 times on some nights gasping to breathe.
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| 62 | 2021-03-30 | insomnia |
After receiving the first shot, developed a headache on right side; later that evening had a runny n...
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After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion. This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.
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| 62 | 2021-03-31 | feeling abnormal |
Fever of 101 that did not respond to tylenol. sever headache that did not respond to tylenol. fast...
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Fever of 101 that did not respond to tylenol. sever headache that did not respond to tylenol. fasting blood sugars went from 100 to 120. 1.5 hour post meal blood sugars went from 130 to 205. brain fog returned I had covid. Positive test was Nov 28, 2020. Last under doctor's care March 19, 2021 but that was a diabetes follow up.
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| 62 | 2021-03-31 | loss of personal independence in daily activities |
I woke up at 5am the next morning feeling like my whole body was frozen. Every joint seemed stuck in...
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I woke up at 5am the next morning feeling like my whole body was frozen. Every joint seemed stuck in place. It was bad everywhere, but worse on my left side -- shoulder, elbow, wrist, hands, and knee. Also my right hand. I took ibuprofen and went back to bed. I wasn't able to do anything. I was extremely tired. I took ibuprofen throughout the day to manage the pain and slept much of the day. I also was coughing quite a lot. Today I feel mostly back to normal. Very little pain or stiffness in my left shoulder, elbow and wrist. Less coughing too.
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| 62 | 2021-04-04 | feeling abnormal |
Foggy Head about 30 minutes post vaccine. Very dizzy and off center that night and the entire next d...
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Foggy Head about 30 minutes post vaccine. Very dizzy and off center that night and the entire next day - about 24 hours. Was walking sideways at times Happening on and off since
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| 62 | 2021-04-05 | anxiety, depression |
Hyper feeling, talkative, then severe feeling of doom and depression a few hours after vaccination. ...
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Hyper feeling, talkative, then severe feeling of doom and depression a few hours after vaccination. She then developed worsened depression along with weakness and temporary hypotension with systolic BP to 50s.
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| 62 | 2021-04-05 | anxiety | apprehension, flushing of skin |
| 62 | 2021-04-05 | feeling abnormal | Light headed/dizziness, tachycardia, nausea, muscle aches, fatigue/exhaustion, brain fog, fever |
| 62 | 2021-04-05 | loss of personal independence in daily activities | Chills, severe headache, joint pain, fatigue, vomiting, unable to do daily functions |
| 62 | 2021-04-05 | restlessness, sleep disorder |
I became itchy, especially in my face. My eyelids got swollen and my eyes were very sore. This con...
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I became itchy, especially in my face. My eyelids got swollen and my eyes were very sore. This continues today, the day after, although the eyelid swelling has gone down a little. My eyes look hooded. I was very restless at night due to the itchiness.
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| 62 | 2021-04-06 | depression |
Severe depression episode occurring the first and second nights. First night I felt suicidal which ...
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Severe depression episode occurring the first and second nights. First night I felt suicidal which is very unusual for me. Some accusing the following 3 days. Still waiting to see what happens moving forward but feeling much better.
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| 62 | 2021-04-06 | feeling abnormal |
On 2nd day after 2nd vaccine, I felt bad and began to have headaches. On about day 8, I began to hav...
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On 2nd day after 2nd vaccine, I felt bad and began to have headaches. On about day 8, I began to have ear ringing along with headaches. It has been 36 days now. The headaches are still present but somedays not as severe. The ear ringing is 24/7 now and extremely annoying. Nothing I do will make it better.
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| 62 | 2021-04-06 | feeling abnormal |
Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year...
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Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman. Brain Fog occurred and slowed speech. Could not lift my arms or stand and needed to be placed in a wheelchair. It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.
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| 62 | 2021-04-06 | sleep disorder |
Within 3 hrs I started experiencing severe hip and leg pain. on left side. Excruciating pain during ...
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Within 3 hrs I started experiencing severe hip and leg pain. on left side. Excruciating pain during nighttime hours to the point you could not sleep. After 3 days it moved to knee. Went to emergency room at 3am April 4th. Discharged with no relief
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| 62 | 2021-04-07 | confusional state |
Day 1 exhausted Day 2: Headache, sore throat, low fever Day 3: low fever abdominal pain on right si...
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Day 1 exhausted Day 2: Headache, sore throat, low fever Day 3: low fever abdominal pain on right side, Day 4: lightheaded /confusion
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| 62 | 2021-04-07 | sleep disorder |
chills, extreme headache, dizziness, nausea, chest pain, racing heart beats, racing thoughts, can't ...
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chills, extreme headache, dizziness, nausea, chest pain, racing heart beats, racing thoughts, can't sleep, left inner ear pain, blurred vision, pain in left elbow, numbness in left hand for 12 hours, shortness of breath, general weakness - adverse events have lasted over 48 hours - Advil taken with minimal reduction in symptoms
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| 62 | 2021-04-08 | anxiety |
Patient is a 62-year-old, female. Alert, oriented X3, clear speech, able to answer to the questions ...
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Patient is a 62-year-old, female. Alert, oriented X3, clear speech, able to answer to the questions before being vaccinated. At 3:34 pm, the patient received her first dose of Pfizer, (lot number EW0150, expires on 07/2021) on left deltoid, given by RN. The patient was able to give her verbal consent to receiving the Pfizer vaccine. RN, reports patient sounded "normal" and was responsive to all pre-vaccination questions. Patient reported mild anxiety to RN, immediately after being vaccinated. RN, followed the patient to the EMT observation area and assisted the patient to a zero-gravity chair. At 3:41 pm, while waiting in observation area, patient reported feeling "anxious" and "faint". EMT (Name), EMT (Name), EMT (Name) and RN, responded. At 3:41 pm, the patient became unresponsive to verbal stimulation. Her pupils were fixed and dilated. During this time, EMT took the patients vitals and found her BP to be 132/98 and HR 73 BPM. At 3:41 pm, RN called 9-1-1. The patient continued to be unresponsive for an additional 5 minutes with normal respirations of 17 per minute. At 3:45 pm, the patient jumped up out of the anti-gravity chair, screamed and proceeded to run down the hallway toward the patient restrooms. EMT followed the patient down the hall and RN followed. The patient collapsed to the floor and started to scream and convulse. While on the ground, EMT took the patient's blood pressure which was found to be 209/162 with a HR of 101 BPM. The patient was assisted to her feet by EMT (Name) and EMT (Name) and assisted her back to the anti-gravity chair at 3:47 pm. FD arrived on site at 3:48 pm and took over monitoring the patient's vital signs. The patient was A&Ox1 to self at 3:48 pm. She was unable to follow direction. Medical response assisted the patient to a stretcher chair with her arms and legs strapped to the chair. She left with EMS at 4:02 pm.
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| 62 | 2021-04-09 | anxiety |
fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pi...
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fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pictures that were kind of ridiculous and seeing things; Severe headaches; Heard a lot of noises in head; body hurting severely where she couldn't walk; body hurting severely where she couldn't walk; no appetite; nauseas; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 62-year-old, on 18Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications were not reported. The patient previously received flu shot as immunization and did not get any reactions and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) on 28Feb2021, single dose for covid-19 immunisation and experienced very achy, some fever, some diarrhea, one episode and a big headache, difficulty Sleeping, and intense sensations. The patient experienced severe side effects/ bad reactions three weeks after receiving the second dose of vaccine. The patient experienced visual pictures that were kind of ridiculous and seeing things (medically significant) on 19Mar2021 with outcome of recovered on 21Mar2021, severe headaches (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, heard a lot of noises in head (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, body hurting severely where she couldn't walk (non-serious) on 18Mar2021 with outcome of recovered on 21Mar2021, fever (non-serious) on an unspecified date with outcome of recovered on 21Mar2021, diarrhea (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, in tears from intensity of the sensation second half of the day after receiving Pfizer Covid Vaccine (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, no appetite (non-serious) on 18Mar2021 with outcome of unknown, nauseas (non-serious) on 18Mar2021 with outcome of unknown, feeling out of body experience (non-serious) on an unspecified date with outcome of unknown. The diarrhea was reported as much more intense. The patient doesn't know how else to describe it, except it was very intense and severe. No appetite and nauseas which lasted 2-3 days, it's almost like feeling out of body experience. The events did not require a visit to Emergency room or Physician office. The patient did not receive vaccination within 4 weeks prior vaccination. No relevant tests performed.; Sender's Comments: Based on the close temporal relationship, the association between the event "seeing thingis" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-04-09 | feeling abnormal, disturbance in attention |
I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; F...
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I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 62 | 2021-04-09 | feeling abnormal, excessive sleepiness |
2am woke up with nausea, severe headache, chills and sweats. Vertigo upon standing. Drank water and ...
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2am woke up with nausea, severe headache, chills and sweats. Vertigo upon standing. Drank water and slept little till 8 am. Took 1 Tylenol at 8, and noon. Had a morning nap and afternoon nap over an hour and normally cannot nap. Took 2 Ibuprofen at 4pm. Aches in joints along with previous symptoms mentioned all day and subsided significantly by 8pm. Was unable to function normally and slept or laid down all day. Felt normal the next morning. Had no arm pain at injection sight at all this time.
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| 62 | 2021-04-09 | insomnia | 100.6 fever, headache, general achiness. lasted 18 hours. Insomnia at outset. |
| 62 | 2021-04-09 | sleep disorder |
8April 10:00AM-11:00AM prickly warm sensation on shoulder, face, near injection site also arms and h...
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8April 10:00AM-11:00AM prickly warm sensation on shoulder, face, near injection site also arms and hands 11:15AM-1:00PM Itchy bumps on both forearms, heart jumps, headache, metalic taste 1:10PM sudden fatigue, sleeping and drinking water for the next 40hours through to 7:00am 9April 3AM severe headache wakes me, I have a fever. 99.1 fever continue to rise throughout all of 9April and head ache does not lessen until after 7am 10 April 4:15AM vomiting 4:49AM HeadAches in every brain cell and in eyes, Temp 99.7 8:20 am temp 99.8 12:00pm temp 99.9 7:00pm temp 100.8 took 2 tylenol 8:40pm temp 100.0 10April 1:11AM temp 97.4 headache persists 7:00am Headache starts to lessen, fatigues persists 1:00pm fatigues abates
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| 62 | 2021-04-10 | feeling abnormal |
Patient reported nausea, headache, "weird" sensation within 15 minutes of vaccination. Had dry heav...
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Patient reported nausea, headache, "weird" sensation within 15 minutes of vaccination. Had dry heaves; IV started, BP 173/101; given Zofran and transported to ER by EMS.
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| 62 | 2021-04-10 | feeling abnormal |
10pm started feeling cold. Then got the shakes for 2 1/2 hrs. Had fever. Woke next morning (Wednes...
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10pm started feeling cold. Then got the shakes for 2 1/2 hrs. Had fever. Woke next morning (Wednesday), nauseous, fever. Foggy and tired Arm painful and couldn?t lift it past waist. Had fever 100.2 Wednesday and Thursday. Still felt tired. Friday morning woke up feeling back to normal
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| 62 | 2021-04-10 | insomnia |
1st reaction - Day 1 As I was walking to my vehicle, after waiting my 15 minutes, I had an awful met...
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1st reaction - Day 1 As I was walking to my vehicle, after waiting my 15 minutes, I had an awful metallic taste in my mouth. I had to spit out the saliva, which helped, but it still lingered for a few minutes. 2nd reaction -Day 1 After several hours, I experienced swelling in my right arm, and diarrhea. I also had insomnia, and slept very little the night of the shot. Day 2 I had loose stools, slight nauseous feeling most of the day. My body odor smelled like onions. I also had bad muscle aches and fatigue. That night, I had insomnia again and slight chills. Day 3 Still had loose stools, fatigue and muscle aches. The onion smell comes and goes. I experienced excessive urination throughout the day (about once an hour, which is not usual for me). Day 4 Muscle aches and fatigue are gone, Day 5 Excessive urination again. Onion smell comes and goes.
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| 62 | 2021-04-11 | anxiety |
Pt states feeling dizzy post-shot. Also complaining of tachycardia. Pt appears mildly anxious. SBP c...
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Pt states feeling dizzy post-shot. Also complaining of tachycardia. Pt appears mildly anxious. SBP checked = 174. Patient states she has high blood pressure. HR checked 80, appears regular. Patient given benadryl.
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| 62 | 2021-04-11 | feeling abnormal |
Lightheaded during the day, dizzy spells upon laying down and getting up, foggy headed. Started abou...
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Lightheaded during the day, dizzy spells upon laying down and getting up, foggy headed. Started about 24 hours after shot.
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| 62 | 2021-04-11 | excessive sleepiness |
Day 2- started out fine, at 9am got bad headache, then started feeling very tired and dizzy, layed d...
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Day 2- started out fine, at 9am got bad headache, then started feeling very tired and dizzy, layed down woke up around 1pm started feeling nauseated ran a fever, stomach was hurting (whole abdomen) had diarrhea had no appetite could not even eat more than 1 bite of a dry bagel. Was so tired couldn't do anything but sleep. Day 3- same symptoms as above but no fever, stomach a little better. Finally at 8pm ate a banana and husband made me eggs. Took until almost 10pm to eat eggs. Day 4- felt much better but still tired and a little weak but was able to walk around house a little and had yogurt for lunch and was able to eat a regular dinner.
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| 62 | 2021-04-11 | panic attack, sleep disorder, loss of personal independence in daily activities |
Severe chilling followed by a panic attack. The next day experiencing pain on the outside of the ri...
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Severe chilling followed by a panic attack. The next day experiencing pain on the outside of the right knee. By 3rd day pain noticed in left and right arms, moving across the top half of the back above the shoulder blades. Excruciating pain by p.m. of the same day preventing me from sleeping. Unable to use arms to get a glass out of the kitchen cabinet. Pain has moved around causing pain and swelling in joints, affecting the right and left arms, wrists, hands, legs. Went to UTC where I was given a steroid shot. The shot lasted about 24 hrs. and right back to the above symptoms. Going to physician today hopefully for some lab work. 11 days of pain!
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| 62 | 2021-04-11 | sensation of foreign body |
Thursday 4/8/2021: Similar Symptoms to previous Vaccine except it was within the 60 minutes. Bumps o...
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Thursday 4/8/2021: Similar Symptoms to previous Vaccine except it was within the 60 minutes. Bumps of Throat, Hard to Swallow, Tongue felt Swollen and warm. Took 2 Benadryl at 5:30P an hour later it was easier to swallow, took 2 more Benadryl at 9:30 PM . Friday 4/9/2021 Similar Symptoms Thursday Bumps on Throat, Tongue felt swollen and warm but easy to swallow But NO TASTE. Took 1 Benadryl every 4 hours. Saturday 4/10/21 Taste Returned, still have bumps on throat and mouth not as warm, queasy stomach and headache. Tylenol only Sunday 4/11/21 Better but still have bumps on throat, headache, queasy stomach and bloated. Monday Better yet bumps on throat only.
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| 62 | 2021-04-12 | anxiety |
Pt developed chest tightness shortly after vaccination. She believes that her chest symptoms are con...
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Pt developed chest tightness shortly after vaccination. She believes that her chest symptoms are consistent with anxiety. She notes anxiety with injections and vaccines in the past. BP 160/90, HR 82, SP02 99%. R: 16. EMS services was recommended but the pt declined and elected to drive home. She is aware of the risks of a potentially serious undiagnosed medical issue.
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| 62 | 2021-04-13 | depression, anxiety, crying, loss of personal independence in daily activities | Severe depression, crying, light-headed, groggy, anxious, lethargic, unable to do normal things |
| 62 | 2021-04-13 | loss of personal independence in daily activities |
First few days, arm pain. Since April 1, I've had much more knee pain. Tremendous and it is affect...
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First few days, arm pain. Since April 1, I've had much more knee pain. Tremendous and it is affecting my daily routines.
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| 62 | 2021-04-14 | feeling abnormal |
Felt fine after vaccine, no ill affects other than a very mildly sore arm. 9 days later woke up feel...
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Felt fine after vaccine, no ill affects other than a very mildly sore arm. 9 days later woke up feeling fuzzy headed, mildly nauseated, generally not well. Later in the day I had bouts of diarrhea and persistent stomach ache (just below ribs), mild nausea?into the night and wee hours. Woke the second day feeling well.
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| 62 | 2021-04-14 | loss of personal independence in daily activities |
Extreme nausea since shots. Had 2nd shot on April 3, 2021 and Nassau has been so bad and so constant...
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Extreme nausea since shots. Had 2nd shot on April 3, 2021 and Nassau has been so bad and so constant that I am unable to do my daily routine. I have to wonder if it has caused a flare up of pancreatitis
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| 62 | 2021-04-16 | impaired work ability |
2 days after the injection i started getting real dizzy, i had to call someone cause i nearly passed...
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2 days after the injection i started getting real dizzy, i had to call someone cause i nearly passed out. they took me back to the office and let me sit there till someone came to relieve me. then i went home. that was on Friday Jan 29, 2021. I stayed out of work for 3days, went back to work on Mon Feb 1, 2021, still being dizzy i continued working till my days off on Wed Feb 3 and Thurs Feb 4,2021. went back to work Friday Feb 5,2021. had to leave work again because of severe dizzines. Called immediately to see if i could get an appointment and got one Saturday Feb 6,2021. then tried again to return to work again on a MondayFeb 8, 2021, worked through with vertigo again till days off Wed Thurs Feb 10 & 11,2021. Tried to work again same thing on Fri Feb 12, 2021. Left work again and been out ever since.
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| 62 | 2021-04-17 | abnormal dreams |
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs...
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passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
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| 62 | 2021-04-17 | feeling abnormal |
eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy ...
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eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 62 | 2021-04-18 | disorientation |
About 20 minutes after vaccine, started seeing visual auras, felt flushing. Auras got worse and fill...
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About 20 minutes after vaccine, started seeing visual auras, felt flushing. Auras got worse and filled vision and felt really disoriented. After about one hour., auras stopped and disoriented feeling subsided.
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| 62 | 2021-04-18 | irritability |
AFTER 11 DAYS, I'VE GOT A STRANGE TEETH ROOT INFECTION (HAD AN URGENT ROOT CANAL TREATMENT) FOLLOWE...
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AFTER 11 DAYS, I'VE GOT A STRANGE TEETH ROOT INFECTION (HAD AN URGENT ROOT CANAL TREATMENT) FOLLOWED BY A HERPES ZOSTER OUTBREAK AND A "COVID ARM" WITH REDNESS, SWOLLEN AND PAIN. THE HOTLINE CORONAVAX IN SWITZERLAND, GAVE ME THE ADVISE TO GO TO THE PHARMACY, EXPLAIN MY EVENT TO THE PHARMACIST. HE LOOKED AT MY "COVID ARM" GAVE ME A POMADE AND GAVE THE ADVISE TO GO THE URGENCY IF IT DOES NOT GET BETTER AFTER 3 DAYS. NOW AFTER 14 DAYS, I AM STILL FEELING A LITTLE CRANKY. MY HEALTH PROFESSIONAL DOCTOR WITH HOMEOPATHIC APROACH, GAVE ME THE ADVISE NOT TO TAKE THE 2ND SHOT. WHAT SHALL I DO?
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| 62 | 2021-04-18 | sleep disorder |
HOT ZINGING FEELING RIGHT ARM, SHOULDER AND CALF ONSET Immediate / DURATION 30 minutes INJECTION SIT...
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HOT ZINGING FEELING RIGHT ARM, SHOULDER AND CALF ONSET Immediate / DURATION 30 minutes INJECTION SITE PAIN day 2 / 2 days TIREDNESS day 2/ ONGOING SEVERE HEADACHE AT PREVIOUS CONCUSSION SITE day 3/ ONGOING but no longer severe CHILLS day 2 / 2 days SEVERE JOINT PAIN AT DAMAGED JOINTS day 2 / 2 days LOW GRADE FEVER day 2 / 2 days VERTIGO/NAUSEA/VOMITING day 2 / 2 days (I LOST 4 LBS) DIZZINESS Day 2 / ONGOING FEELING GENERALLY UNWELL day 2 / 2 days FACIAL PALSY RIGHT SIDE INLCUDING EYE SOCKET day 1 / BAD ON DAY 1, LESSENING EACH DAY BLURRY VISION RIGHT EYE Immediately / ONGOING INTERMITTENT HYPERTENSION Day 3 / Lasted all night. I couldn't sleep. Was sort of vibrating. Got up to 168/107. Was down to 116/88. Now bouncing around and up again at 150/96. My norm is 110/70ish. When I got the shot I had to sit with an EMT for 90 minutes because of the facial palsy. Then I was massively sick for 3 days. Vertigo, dizziness, and vomiting were the worst. Now the pain at concussion site and continuing dizziness is lousy, plus the BP increase started last night and is bouncing around. Maybe it will settle down like all the rest of the side effects. Seemed like each day brought on new side effects and they last from 12 to 48 hours.
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| 62 | 2021-04-19 | abnormal dreams, insomnia |
Ever since receiving vaccine, I have been unable to stay asleep for more than 1or 2 hours at a time....
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Ever since receiving vaccine, I have been unable to stay asleep for more than 1or 2 hours at a time. Also, very vivid dreams. Both of my 2 brothers are having the exact same side effects
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| 62 | 2021-04-19 | hallucination |
body aches, chills, headache, fatigue, night sweats, loss of appetite, severe pain, hallucination, t...
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body aches, chills, headache, fatigue, night sweats, loss of appetite, severe pain, hallucination, talking in sleep, cough
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| 62 | 2021-04-19 | insomnia |
I noticed a rash on my torso on Monday night - 4/12/21. It reminded me of chicken pox. It became i...
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I noticed a rash on my torso on Monday night - 4/12/21. It reminded me of chicken pox. It became increasingly itchy. On Tuesday it was more pronounced (redder) and itchier. I had difficulty sleeping on Tuesday 4/13/21 evening and the itching and redness became even more intense. I called my health care provider on 4/14/21 and was told to take Benadryl and/or Claritin and apply ice pack to itchy patches and avoid hot water showers. I used an ice pack throughout the day on Wednesday. On Wednesday evening I took 1 Benadryl at 9 p.m. and applied an ice pack throughout the night to sleep. I used the ice pack throughout the day on Thursday and took 1 Benadryl at 9 p.m. on Thursday 4/15/21. The itchiness, redness and spots were decreasing throughout the day on Thursday. I used an ice pack overnight for relief to sleep. When I woke on Friday 4/16/21 the rash was about 95% gone and the itchiness greatly reduced. I was comfortable, had no spots and had normal energy starting Saturday 4/17/21. The rash never got hot to the touch, just very itchy and uncomfortable.
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| 62 | 2021-04-20 | hallucination |
Severe migraines for 4 days. Last two day could not get out of bed. Vomiting and could not eat. Then...
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Severe migraines for 4 days. Last two day could not get out of bed. Vomiting and could not eat. Then 2 days of lower grade headaches. This has been followed with some hallucinations at night just before bedtime.
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| 62 | 2021-04-21 | insomnia | Jitteriness in the evening, total insomnia that night, but no fatigue the next day. |
| 62 | 2021-04-21 | memory impairment, confusional state |
TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakn...
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TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakness of left arm and leg, headache, slurring of words - 3 days in Hospital - resulted in damage to memory, confusion, weakness in left arm+leg, severe headaches - ongoing, but slightly improved after 3 weeks. Also diagnosed with acute cerebrovascular accident.
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| 62 | 2021-04-22 | sleep disorder |
Approximately two days after receiving the second dose of the vaccine. my left arm and shoulder beca...
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Approximately two days after receiving the second dose of the vaccine. my left arm and shoulder became very sore. I have trouble lifting it and cannot lay on that side without pain.
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| 62 | 2021-04-23 | anxiety |
Severe Headache, Vomiting, high fever over 103 (my base temp is always 96.5-97)complete body aches, ...
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Severe Headache, Vomiting, high fever over 103 (my base temp is always 96.5-97)complete body aches, chills, lightheadedness tiredness. Headache better after 24 hrs, but now 4/24 it is back. The fever went down to 100 but today is inching back up. Still achy and extremely tired and I have lightheadedness and fainted today. Off and On I feel chest pain, but it could be anxiety.
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| 62 | 2021-04-24 | feeling abnormal |
I felt a little woosy; This is a spontaneous report from a contactable other health care professiona...
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I felt a little woosy; This is a spontaneous report from a contactable other health care professional (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration, administered in Arm Right on 05Apr2021 13:00 as single dose for covid-19 immunisation. Medical history included Severe back problems. Patient had allergies to Chocolate. Concomitant medication was not reported. On 05Apr2021 01:15, patient felt a little woosy. She was not pregnant at the time of vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. She was not received treatment for the adverse event. Patient was not diagnosed with COVID-19 Prior to vaccination, since the vaccination, not been tested for COVID-19. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 62 | 2021-04-24 | feeling abnormal |
immediately started with tingling on tops of both feet particular on left foot/ tingling in toes; I ...
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immediately started with tingling on tops of both feet particular on left foot/ tingling in toes; I am having trouble with my left foot; it's a sensation of tingling that is weird; tripping periodically; It doesn't hurt but it could hurt/pain threshold/foot; it is like I have drop foot / Like foot drop; This is a spontaneous report from two contactable consumers (patient and her husband). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ENS208 (patient's husband also reported that the 3rd digit could be a 6 or an 8, patient added that it was EN8208 but her husband stated he was less confident)), via an unspecified route of administration, administered in Left Arm (also reported as left shoulder) on 11Mar2021 at 15:00 (at the age of 62-year-old) at single dose for there's a pandemic going on. Medical history included she walked everyday and exercise a minimum of 45 min/day, for years, 20 years; high blood pressure; her condition, there was something in her esophagus and there was a problem; had a problem with her parathyroid and they removed it, there were 4 nodes and they took 2 and there were still 2. Patient's mother is 99 and had an accident. Ongoing concomitant medications included lisinopril from an unspecified date (reported as has been on 10 years or so, so a long time) for high blood pressure; colecalciferol (VITAMIN D) from an unspecified date (reported as has been on for about 3 years) as she had a problem with her parathyroid and they removed it; alendronate sodium (ALENDRONATE) from an unspecified date (reported as has been on for approximately 3 years) for bones and back to make sure she has enough calcium in her bones; pantoprazole from an unspecified date (reported as has been on around 3 years but she does not remember, it has been about three years) for her condition, there is something in her esophagus. Despite all of these medications she is healthy. Patient reported that she did not know if this was vaccine related or not, but the timing was. She got the vaccine on 11Mar2021, and immediately started with tingling on tops of both feet particular on left foot on the way home, which was side she got vaccinated on. She got tingling immediately following vaccination on 11Mar2021, and it's worse now but stable, not getting worse, it was like she have drop foot, sort of like that in 2021, she had to remember to lift her foot. She exercise. She walked everyday and exercise a minimum of 45 min/day, for years, 20 years. She had been walking and now she was having trouble with her left foot in 2021. Tingling on feet started right away, she drove back from vaccination site about an hour. She was able to drive and walk, it's not stopping her life she was tripping periodically mostly on her left foot in 2021, because she was not always conscious of lifting her foot. It's not painful, it's a sensation of tingling that is weird, it did not hurt but it could hurt, if it got worse it could be in the pain threshold, it's just in the annoying threshold in 2021. Like foot drop, like nerve damage on the top of left foot in 2021. She thought that if she didn't have a vaccine, she would say it felt like a nerve damage sort of thing, in both feet but predominantly in left one giving her trouble. Patient's husband added that the tingling was not excessively painful, it easy for him to say it was not painful. Tingling in toes was primarily on the left. She added that the tingling was not debilitating but it was just her husband she did not know if it had anything to do with the covid19 vaccine. No previous immunizations with suspect product. No additional vaccines administered same date. No AE required visit to Physician's Office or Emergency Room. No prior vaccination within 4 weeks. Family medical history relevant to AE was none. No investigation assessment for this, she had a physical next week which was just standard and just a standard battery of tests. Therapeutic measures were taken as result of all events included lifting her foot. The outcome of the event tingling was not recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-04-24 | loss of personal independence in daily activities |
Extreme joint pain, knee & hip, affecting ability to function in normal activities of daily living, ...
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Extreme joint pain, knee & hip, affecting ability to function in normal activities of daily living, mobility, etc. And also requiring opioid pain medication daily in order to treat/manage debilitating joint pain.
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| 62 | 2021-04-24 | loss of personal independence in daily activities |
In pain; Could barely eat; feeling full; Taste buds are completely shot; muscles ache; can barely mo...
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In pain; Could barely eat; feeling full; Taste buds are completely shot; muscles ache; can barely move when stand up; muscle weakness; really weak; This is a spontaneous report received from a contactable consumer (patient husband). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: ER8737, Expiration Date: Jul2021), via an unspecified route of administration on arm right on 02Apr2021 probably about 13:30 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient had no family medical history. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not visit to Emergency room or Physician office. The patient had no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. It was reported that, the caller is a consumer reporting he and his wife had their first dose Pfizer Covid Vaccine on 02APR2021. Caller reports his wife experienced the same side effects as the caller. Caller's wife was really weak in Apr2021 and was experiencing all the same symptoms as the caller except no chills and no difficulty sleeping. Reports when the wife lays down, she was out cold asleep, and has no difficulty sleeping. The caller states the afternoon after receiving the Pfizer Covid Vaccine when leaving the administering facility, so far nothing bad had occurred. Caller reports he and his wife stopping to get something to eat on the way home from the Vaccination administering site, and in his case he could barely eat on 02Apr2021. This was the same for his wife. It was like it was not digesting on 02Apr2021. She has a feeling of feeling full and not being able to eat on 02Apr2021. Her taste buds are completely shot. Whenever she eats something it taste like cardboard. Mentioned his wife tries to eat because she needs to. She cold, barely finishes her food at the restaurant they went to after getting the first dose. It was like their food was so bland. Caller confirms some of the symptoms he reports are the same for caller's wife. Reports caller's wife is similar to him. She has muscle aches and can barely move when stand up in Apr2021. Caller explained his muscles ache like being beaten with a baseball bat and it's the same for his wife. Muscles ache constantly. Confirmed she was also having muscle weakness in Apr2021. Confirmed his wife was really weak. She can barely stand up. If she sits down on the chair or in a car in the drivers seat, its almost like caller was going to fall asleep. The outcome of the event was reported as unknown. No follow-up attempts are needed; No further information is expected.
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| 62 | 2021-04-25 | confusional state |
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M...
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Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe
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| 62 | 2021-04-25 | insomnia |
Just want to let you know my tinnitus increased increasing my anxiety and making it difficult to rel...
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Just want to let you know my tinnitus increased increasing my anxiety and making it difficult to relax and sleep. My hearing test just showed hearing decrease from my last test. And subjectively I feel a loss of hearing and difficulty sleeping I did not have before. I thought you should know and would like to know if others are getting tinnitus or increased tinnitus.
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| 62 | 2021-04-25 | sleep disorder |
Injection site began to hurt within the 15 minutes of wait time after the injection. Left arm was ve...
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Injection site began to hurt within the 15 minutes of wait time after the injection. Left arm was very painful within 24 hours of injection and physically exhausted Tinnitus set in approximately two weeks after second injection. Accompanied by pain in both ears, sometimes throbbing. The tinnitus is day and night and sleep is affected. I have contacted my doctor asking for help.
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| 62 | 2021-04-27 | abnormal dreams |
Symptoms: Patient reports balance issues since receiving her COVID vaccine. (received vaccine 4.16....
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Symptoms: Patient reports balance issues since receiving her COVID vaccine. (received vaccine 4.16.21) She fell the first evening (4.16.21) after losing her balance. She denies significant dizziness, weakness or numbness. She fell again yesterday (4.27.21). (called nurse triage line to report on 4.28.21) She also reports worsening of her urinary incontinence and isn't sure if its related. She reports a headache only because she fell hit her head when she fell. Balance issues-recent fall twice concern seeking medical advice Noticed no balance control Noticed increased of dreams of falling while sleeping first fall on same day of vaccine 7:30pm second fall yesterday -around 10am Symptom duration: couple days Recommended ED or Urgent Care - no follow up or visit by patient at this time of reporting (evening 4.28)
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| 62 | 2021-04-27 | sensation of foreign body |
Nausea, dizziness, lump in throat, rapid heartbeat, suppressed breathing, headache, muscle pain, chi...
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Nausea, dizziness, lump in throat, rapid heartbeat, suppressed breathing, headache, muscle pain, chills, joint pain, fever, injection site swollen, hot, and red size of 50 cent piece
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| 62 | 2021-04-30 | confusional state |
felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell h...
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felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.
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| 62 | 2021-04-30 | feeling abnormal |
My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; ...
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My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; My nasal passages, throat, and bronchial tubes started to swell up; My nasal passages, throat, and bronchial tubes started to swell up; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 62-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 (Batch/Lot Number: ER8729) (at the age of 62-years-old) as single dose for covid-19 immunization. Medical history included known allergies: penicillin from an unknown date. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 18Mar2021 01:45 P.M. (Batch/Lot Number: ER2613) (at the age of 62-years-old) for covid-19 immunization. The patient did not get COVID prior vaccination and did not receive COVID test post vaccination. About five minutes (as reported) after the patient received the shot, she started feeling faint on 08Apr2021 02:15 P.M. Her nasal passages, throat, and bronchial tubes started to swell up on 08Apr2021 02:15 P.M. Taking a decongestant when she got home helped that. For a few days she had congestion and brain fog along with general malaise. Treatment received included she took decongestants. The outcome of the events was resolved in Apr2021. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-05-03 | feeling abnormal |
She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy;...
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She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy; body aches; She felt like she was on a boat/ she was not feeling right; had soreness in her arm; has zero energy; She fell asleep in her sunroom and got up around 3:00PM; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158; Expiration Date: Jul2021, NDC not known), via an unspecified route of administration, administered in right arm on 16Apr2021 at 10:00AM (at the age of 62-year-old) at single dose for prevent Covid 19, she wanted to feel safe traveling. No additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. Medical history included ongoing rheumatoid arthritis and prior to receiving her Covid 19 vaccines she reached out to her rheumatologist to see if she would be ok getting the Covid 19 vaccine while taking her medications, her rheumatologist told her she would be ok to receive the Covid 19 vaccine. Ongoing concomitant medications included methotrexate injection and hydroxychloroquine. No prior vaccinations within 4 weeks. The patient previously was made to get a flu vaccine for work about 20 years before for immunization, the flu vaccine made her violently ill, she ended up having to go to an Urgent Care, she had to call her mother to come get her, she could not even get out of bed, she had to stay home a week from work because she was sick; she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 (at the age of 61-year-old) at single dose for COVID-19 immunization and experienced fever, everything in her body ached, every time she bended over, if her head got below her shoulders to pick something up she would black out and vertigo. When she received her second Covid 19 vaccine her symptoms started again on 16Apr2021. She felt like she would pass out if she didn't feel the black out sensation coming on. She didn't know how long she blacks out for. She tried to grab a hold of something, for example, she was in the shower shaving her legs and she reached down to shave her legs and she could feel herself starting to pass out. She had a ledge or seat in her shower and she grabbed the shower wall and lowered herself to a sitting position on that ledge in her shower. The feeling passed and she tried to shave the other leg and the same thing happened again. When she's sitting on her sofa and she bended down to the floor to pet her small dog, all of a sudden she could feel herself moving forward like she was going to fall forward. Her husband grabbed her arm and pulled her to an upright position and asked her if she was ok. She reported her normal body temperature was 96.9 degrees Fahrenheit on an unspecified date. She was not someone who ran 98.6 degrees Fahrenheit. She reported her temperature had been about 98.8-98.9 degrees Fahrenheit on an unspecified date and that to her was a fever. She was still running a fever. She reported she had been afraid to drive because she was afraid she would pass out. She knew she did not have vertigo. She did a have a yearly check up with her primary care doctor and she was going to talk to her doctor about what's happening. She received her Covid 19 vaccine with her husband at about 10:00AM. Shortly after when she and her husband were driving home, she told her husband she was dizzy on 16Apr2021. She felt like she was on a boat. Even if she looked up or bent over was when she got dizzy. Her fever started right away after her vaccines on 16Apr2021. She also had soreness in her arm and everything in her body aches on 16Apr2021. She had zero energy on 16Apr2021. She was still feeling this way now. She fell asleep in her sunroom and got up around 3:00PM on 16Apr2021. Not any adverse events required a visit to Emergency Room nor Physician Office. The outcome of the event fell asleep was unknown, outcome of the other events was not recovered.
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| 62 | 2021-05-10 | excessive sleepiness |
Major joint pain and inflammation in knees and ankles Major tiredness. Did not wake up on May 7. M...
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Major joint pain and inflammation in knees and ankles Major tiredness. Did not wake up on May 7. My husband had to call 911 as my Blood sugar dropped to a low of 17 I almost died
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| 62 | 2021-05-12 | feeling abnormal |
having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had s...
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having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had severe headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8727, second dose) solution for injection intramuscular in the left arm on 25Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disease (diagnosed with probably 20-21 years ago) and blood pressure increased (takes blood pressure medicine). Concomitant medication included hydrochlorothiazide for blood pressure increased began taking this 4 or 5 years ago. Historical vaccine included BNT162B2 (first dose, lot EN6200) for COVID-19 vaccination on 04Mar2021 with no adverse effect reported. On 25Mar2021, the patient was feeling kind of funny and had a severe headache. In Apr2021, the patient had faint spells and blood pressure was a little bit higher than normal at 137/80 which began after the second dose Pfizer Covid Vaccine. The patient stated she never felt like fainting before in her life. Her blood pressure was never over 150 and can't keep blood pressure under 130 for some reason. The outcome of the events feeling kind of funny and headache was unknown. The outcome of the events faint spells and blood pressure was a little bit higher was not recovered. Information on batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event faint spells and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-05-19 | feeling abnormal |
This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored prog...
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This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-05-20 | restlessness |
She got her vaccine and within 10 minutes she felt like her heart did a big woosh and was sitting wi...
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She got her vaccine and within 10 minutes she felt like her heart did a big woosh and was sitting with her husband and told him that it was hitting her blood stream as she had not had the reaction since starting some medication due to lupus. The first hour it was fairly overwhelming wooshing sensation that made her feel uncomfortable and restless, and then got less. Over the course of the week it continued to happen and did not feel right. She called her PCP and by the time she got to see him on 5/20/21 it had been a month, but had not worsened to go to the ER. She had an EKG that showed acquired long QT syndrome, and told her that she could not get the 2nd vaccine. He said that if she got hte 2nd vaccine that there was a likelihood that she would develop Torsades de pointes and that it could be life threatening. Now he has to be careful on what to treat her due to this condition. He told her to take really good care of herself and to continue take her medications and if it got worse to go to the ER. She will FU with him in a month and he would continue to check EKG's to see if it will go away or not. She is more tired and if she goes up and down the steps she is out of breath much quicker than before this condition. She had several normal EKG's in the past that he compared the last one with and she did not have this condition on previous EKG's. She wishes that they would put out information for people who have autoimmune issues to publish these reactions to be watchful of reactions. Feels they need to update the website to report similar side effects.
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| 62 | 2021-05-23 | feeling abnormal, disturbance in attention |
Five days after the second COVID dose I experienced what I thought was motion disturbances similar t...
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Five days after the second COVID dose I experienced what I thought was motion disturbances similar to a head concussion (week long symptoms) I had six months ago. When I looked into what brain fog was with the vaccine it was very evident that was what was going on. I actually did not realize how bad it was until much later when it cleared. Difficulty focusing and having to repeat processing events that has never happened before. Difficulty sitting and following conversation after an hour need to get up and leave. Still some motion dizziness when turning head fast or downward such as putting on shoes.
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| 62 | 2021-05-23 | feeling abnormal |
Onset of strong nausea, chills with fingertips turning blue and fever. Brain fog and exhaustion mad...
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Onset of strong nausea, chills with fingertips turning blue and fever. Brain fog and exhaustion made it difficult to get up throughout the evening into the next day. Nausea, headache and low-grade fever continue to linger and it has now been 3 full days. Developed an "angry" looking rash in lower left groin area - large red splotches with some itching and discomfort. Noted rash on the day following the injection and it hasn't diminished as of today.
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| 62 | 2021-05-23 | nervousness, sleep disorder |
Approximately 5 minutes after shot was administered into my left upper arm, as I sat down to wait my...
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Approximately 5 minutes after shot was administered into my left upper arm, as I sat down to wait my 15 minutes as required, I started to feel a racing heart, lightheaded, shaky, nauseous and strange sensation in my body. I was with my mother and my husband. My husband noticed I was struggling and called over the paramedic on staff. He came over and asked me questions, as to what I was feeling, he brought over a bottle water and asked if I wanted some Cola for the nausea, apparently it helps with nausea. At first I didn't want it, then I ended up taking a few sips. The entire episode lasted approximately 30-35 minutes, and I felt my heartrate returning to normal, however, I continued to feel out of sorts, shaky. Upon returning home, the entire evening of the day in question, I felt a heaviness in my head, ache over my eyes, then my body continued to feel strange, I was very tired, and of course, my arm began aching, I barely slept through the night, feeling strange sensations in my body, aching arm, and headache, nauseated. I had taken Tylenol after getting home from the vaccine shot. I finally got what I remember, maybe 2 hours of sleep, waking up to go to the bathroom, and my legs felt like cement! I could barely walk! Pain was radiating up the back of my legs, thighs, and buttocks. I held myself along the wall to the bathroom and could barely bend. After using the bathroom, I once again felt a tremendous heaviness, cement-like legs, barely making it back to the bed. Throughout the entire day I could barely walk, severe muscle spasms lower back, thighs stiffness, down the back of legs, severe pain. I contacted my doctor, told him of what was happening and he stated not to go back for the 2nd shot due to my issues with the 1st. This has been ongoing since April 28, 2021, today is May 24, 2021 almost one month later and I am no better. Although I have had Fibromyalgia for several years and Chronic Fatigue Syndrome, since the vaccine, it has triggered a complete relapse of my condition, making it unbearable, painful. I have been living on pain meds, and icing/heating on and off. Now requiring physical therapy.
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| 62 | 2021-05-24 | insomnia |
I noticed I was experiencing tinnitus / ringing / buzzing in my ears about 3-4 days after receiving ...
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I noticed I was experiencing tinnitus / ringing / buzzing in my ears about 3-4 days after receiving the first Pfizer dose. It was rather pronounced, particularly at night. I have also seemed to have increased level of insomnia as I try to get to sleep. It hasn?t been terrible but both symptoms can be annoying at times. The buzzing in my ears can sometimes be hardly noticeable but at other times it seems a bit loud, particular when I am trying to get to sleep. It sounds like what they call pink noise. It does not seem to be affecting my hearing acuity.
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| 62 | 2021-05-25 | feeling abnormal |
Headache; fever; aches; sleepiness; brain fog; flu-like symptoms (Just like Covid that I had); This ...
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Headache; fever; aches; sleepiness; brain fog; flu-like symptoms (Just like Covid that I had); This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right (at the age of 62) on 22Feb2021 10:00 (Lot Number: EL9267) as single dose for covid-19 immunisation. The patient medical history included covid prior to vaccination. No known allergies. Concomitant medications included imipramine, propranolol. The patient experienced headache on 22Feb2021 14:00, fever on 22Feb2021 14:00, aches on 22Feb2021 14:00, sleepiness on 22Feb2021 14:00, brain fog on 22Feb2021 14:00, flu-like symptoms on 22Feb2021 14:00. No treatment received. No covid tested post vaccination. The events outcome was recovering. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-05-27 | feeling abnormal |
(5/26) received 2nd covid vaccine at facility. Woke up on 5/27 feeling bad, left arm sore with the ...
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(5/26) received 2nd covid vaccine at facility. Woke up on 5/27 feeling bad, left arm sore with the feeling of a tennis ball in my left arm pit (axilla) and sore or tender to touch. On (5/27) evening slept all night with left arm elevated on pillows. (5/28) Went to Urgent care /known side affect symptom (lymphadenopathy in left arm axilla d/t covid vaccine #2). When asked what I could take as pain tablet; Ibuprofen was recommended d/t trx of inflammation. As you can see from my date of vaccination, I have been reluctant to get this vaccine d/t side affects and my own known medical history. To my knowledge, i have not had Covid and have always worn a mask. So here I am.....
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| 62 | 2021-05-27 | insomnia |
She got her vaccine, she did not have any reaction that day. Her arm hurt a little when she was sle...
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She got her vaccine, she did not have any reaction that day. Her arm hurt a little when she was sleeping. She woke up the next morning and had severe chest pain, which did not stop no matter what she was doing during the day, even sitting down. The following day when she woke up everything was back to normal. She waited one additional day to make sure it was not a microvascular issue she had, and did not get it again and still does not have any issues. She did call her cardiologist who told her not to take the 2nd vaccine. The day they were going on she just took her regular medication and monitored her heart rate and her BP.
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| 62 | 2021-05-31 | loss of personal independence in daily activities |
Extreme Fatigue/Lethargic - Wake up tired and not refreshed. Constant fatigue and sleepiness. Inf...
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Extreme Fatigue/Lethargic - Wake up tired and not refreshed. Constant fatigue and sleepiness. Inflammation beyond belief. Pain in places that I have never felt. Left shoulder, Right shoulder, Right leg and left leg tendons. I am struggling to to normal activities. Increase in the intensity and severity of the pain, and tenderness and soreness associated with fibroymalgia. Example: Woke up at 7 am, had breakfast, Mani/Pedi Appt at 11 am, Could hardly stay woke for Mani, but slept through the Pedicure. This is getting to extremely overwhelming for me to deal with.
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| 62 | 2021-06-01 | loss of personal independence in daily activities |
burn feeling on her arm; pain at the injection site; shoulder and arm have been hurting; shoulder an...
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burn feeling on her arm; pain at the injection site; shoulder and arm have been hurting; shoulder and arm have been hurting; having a hard time getting dressed and lift her arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: unknown) via an unspecified route of administration on 30Apr2021 (at the age of 62-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccines included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) on 13Apr2021 as single dose for COVID-19 immunization. She stated that the nurse who administered the 2nd dose asked her to pull her arm down and had burn feeling on her arm when she received the shot on 30Apr2021. She had pain at the injection site. Her shoulder and arm have been hurting ever since she got the 2nd dose. She was having a hard time getting dressed and lift her arm in 2021. She wanted to know recommendations to manage the symptoms and how long usually the symptoms last. The outcome of events is unknown. Information on the lot/batch number has been requested.
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| 62 | 2021-06-02 | insomnia |
hearing loss in both ears; hypersensitive to sound; painful; trouble sleeping; tinnitus; tinnitus; T...
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hearing loss in both ears; hypersensitive to sound; painful; trouble sleeping; tinnitus; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 16:00 (Batch/Lot Number: er8727), age at vaccination of 62-years-old, as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:00 (Batch/Lot Number: ew0151), age at vaccination of 62-years-old, as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing (mild asthma), drug hypersensitivity from an unknown date and unknown if ongoing (allergies: sulfa drugs), tinnitus from an unknown date and unknown if ongoing (mild tinnitus diagnosed 10 years ago), deafness from an unknown date and unknown if ongoing (diagnosed 10 years ago). The patient received tetanus vaccine in left arm on 12Mar2021 within 4 weeks prior to the COVID vaccine (age at vaccination of 62-years-old). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported and hormone replace taken for an unspecified indication, start and stop date were not reported After the vaccine (both doses) tinnitus rose exponentially, and patient was diagnosed with hearing loss in both ears. Not sure when the additional hearing loss took place. The patient also become hypersensitive to sound, it was almost painful. The patient had trouble sleeping, listening to tv, music, going out to restaurants, etc because of this reaction. ENTs can only recommend hearing aids. After 9 weeks tinnitus has quieted a little bit but not back to pre vaccine level. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Treatments were given for the events (after first vaccine took a course of prednisone). Outcome for the events was unknown. Follow-up attempts are possible. Further information is expected.
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| 62 | 2021-06-03 | sleep disorder |
Two weeks after Dose 2, given on 4-17-21, woke up with persistent muscle twitching in legs, somewhat...
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Two weeks after Dose 2, given on 4-17-21, woke up with persistent muscle twitching in legs, somewhat migratory to upper body as well. This lasted from approx. 5 -9 AM, and receded as I started activity (or I didn't notice it.) This persisted for 2 weeks, every morning. Also, at this time developed clonic muscle jerks-- of legs, one hand curling, chest jumps, pelvic/lower abdominal bilat jerks, shoulder or arm jerks. This disturbed sleep on a couple occasions. Mild AM headaches for 2 weeks, and for last 3 days sharp R-sided head pains, scalp itching, and discomfort in the evening. Myoclonus seems better today after 3 days of taking NAC (N-acetyl cysteine) and herbs.
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| 62 | 2021-06-06 | impaired work ability | asthma flare which lasted 4 days, missed work as a result |
| 62 | 2021-06-07 | amnesia |
Stomach ache; Severe breast pain; I'm very tired still; She can't remember anything; Lethargic; Weak...
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Stomach ache; Severe breast pain; I'm very tired still; She can't remember anything; Lethargic; Weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8730 and Expiration date: Jul2021), via an unspecified route of administration in left arm on 29Mar2021 (age at vaccination 62-year-old) at 1st dose single dose for covid-19 immunisation. Patient Medical history included covid-19 from Nov2020 to an unknown date, tachycardia from Nov2020 and ongoing, postural orthostatic tachycardia syndrome from Nov2020 and ongoing, Brain fog from Nov2020 and ongoing. The patient's concomitant medications were not reported. Patient got Covid-19 infection on Nov2020. She said that she was a long hauler which means that she still has POTS (Postural Orthostatic Tachycardia Syndrome) and brain fog from COVID-19. She said that she has antibodies. Patient reported that she had been reading a lot of stuff and queried if it was ok for her to have gotten the Covid-19 vaccine after having Covid-19 in Nov2020. Patient inquired after being informed that she would be transferred Mortgage Insurers (MI) for her questions if she should wait to ask the other questions that she had as they were all medically related. agent offered to relay her questions to MI if a live agent was reached but Patient did not provide other questions. Patient reported that she had her first dose of the Covid-19 vaccine about an hour ago. Lot Number: Patient reported that she was pretty sure the lot number was ER8730 but stated that it could possibly be ERS730 as the 8 looked a bit like an S. Patient asked that why she still having these symptoms 2 weeks out after the vaccine. She had a stomach-ache and severe breast pain (the left side where I got the vaccine). It radiates into her left breast. When she leans over, it was severe to where she cannot touch her breast. The pain goes away, but it was random. She was very tired still. Patient asked that should she get the second dose. agents were busy during attempt to warm transfer. Thus, Adverse event E-transmitted. responded per CONS documents and provided disclaimer that Pfizer is unable to make recommendations for individual patients. Patient was asking if she has to start the series all over again if her second dose is delayed. Response: Responded per CONS document. Again, RN called as patient said that she called last week about the Pfizer COVID-19 vaccine that she took the first dose of on March 29th. She says she called today to provide more information, and to ask a question. She says after she took the first dose of the vaccine on the 29th she was still very tired, and her breast pain was worse. She says she has never had breast pain before, it was on the same side where she got the vaccine in her arm. She said her arm did not hurt, which she wondered about, but it went down into her breast lymph nodes, and her breast was hurting when she pushes it forward, she sits up or bends forward. She said it was hurtling so bad, and she was very tired, she does not know why it was taking two weeks. She said she was also still having brain fog. Patient said she cannot remember what she provided previously on her other report, she cannot remember anything. Patient said she had COVID in November2020 and now she had the vaccine and still can't get over it. Patient said that when she holds her breast forward, she feels the pain. She said she was very lethargic, and she had a stomach-ache until 28Mar2021 (yesterday) when she decided to drink Gatorade. She said she drank two bottles and the stomach-ache seemed to ease up. She said that the breast pain was frightening to her, it was a real sharp pain that was so bad that afterwards she can't touch until 5 seconds later. Patient says she wanted to know if she can still get her second dose in ten days and says that she doesn't know what the second dose will do to her if after the first dose it has taken two weeks to recover. Patient also mentioned that she had COVID-19 last Nov2020 and had tachycardia ever since. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine by the end of Mar2021 and had a bad Case narrative reaction (tachycardia, weakness, & fatigue). Patient is scheduled to receive the second dose on 26Apr2021. Patient asked that will she overdose (od) of antibodies. Patient already reported to Safety and confirmed. Checked the Pfizer-BioNTech COVID-19 EUA PI (LAB-1457-7.0, Revised: 06 rApr2021), mentioned no information found on possible antibody overdose, discussed Immunization Practices (IP) recommendation, gave disclaimers, and referred to health care professional (HCP) for guidance. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. .
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| 62 | 2021-06-07 | sleep disorder |
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizz...
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Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Joint Pain-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Pt started experiencing syncope, chest pain, and neck pain on 5/31/2021. On the following Tuesday, she developed palpitation. On Wednesday, she was taken to ER by ambulance. At the time, she had rapid heart rate at 127 bpm. She was on IV fluid. On Friday, pt visited her cardiologist. She still experiences chest discomfort, lightheadness, and out of breath.
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| 62 | 2021-06-08 | sleep disorder |
Massive migraine, nausea, whole body aches, chills, inability to sleep, painful injection site, lowe...
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Massive migraine, nausea, whole body aches, chills, inability to sleep, painful injection site, lower back pain, chest pain, sweats. This was equal to or worse that when I had Covid during the winter.
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| 62 | 2021-06-08 | sleep disorder |
The morning of February 21, 2021, I started having severe burning in my chest and in my back. It pre...
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The morning of February 21, 2021, I started having severe burning in my chest and in my back. It prevented me from sleeping without sitting up. I did not report to work for 3 days. I thought it was gastrointestinal since I already had covid in November 2020. After having another covid test on March 1, 2021, after being fully vaccinated, I tested positive for covid again. That prevented me from having a scheduled colonoscopy. I eventually had my routine colonoscopy on April 2, 2021 at the Clinic.
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| 62 | 2021-06-09 | feeling abnormal |
blood clot already eliminated; pain; This is really miserable because it persisting and it is always...
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blood clot already eliminated; pain; This is really miserable because it persisting and it is always there; I feel like frustrated; light pink rashes in the back from knee above in both legs; both of my legs below the knees had really bad itches; mild pain in the back of the upper left leg; sharp pain at a spot in my left hip joint; Sore in the injection area; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 15:30 (Batch/Lot Number: EW0169; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation, age at vaccination 62 years old. Patient is not pregnant at vaccination time. Medical history included diabetes mellitus from Sep2020 to and blood pressure (abnormal) from an unknown date. Concomitant medications included metformin taken for diabetes mellitus, start and stop date were not reported; dapagliflozin propanediol monohydrate (FARXIGA) taken for diabetes mellitus, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure (abnormal), start and stop date were not reported. Clinical course was reported as follows: On 24Apr2021 noon (12:00), patient suddenly felt a shar at a spot in her left hip joint. It was then moved to the mild pain in the back of the upper left leg, which never disappeared. The pain there got a lot worse, so severe, also reported as now just a mild pain. Patient went to bed around 12 am on 25Apr2021, both legs below the knees had really bad itches; by next day 6 AM it was gone and never returned. On 26Apr2021, in late afternoon, in the back of both of the legs started bad it itches, and patient saw light pink rashes in the back from knee above in both legs, which disappeared by midnight, and never again noted. Sore in the injection area (Apr2021) similar to flu vaccine, which was gone after a few days. Patient stated adverse reaction getting worse and asked how it can be resolved because he can't function normally because of adverse effect. Patient stated that this is really miserable because it is persisting, and it is always there. He stated he is a normal person his breath, he still sees, still read, and is sound. He feels he is in constant pain, mild pain is annoying, but this week is so worse. Patient stated his "blood clot already eliminated" (onset date unspecified, event not clarified). Patient felt frustrated. Second dose was scheduled on 14May2021, but he didn't take it, he cancelled the second dose because of pain. Treatment was not given for the events (does not take medications). Outcome of the events "blood clot already eliminated" was recovered on an unspecified date, "both of my legs below the knees had really bad itches" was recovered on 26Apr2021, "light pink rashes in the back from knee above in both legs" and "Sore in the injection area" was recovered on Apr2021. Outcome of "sharp pain at a spot in left hip joint" and "mild pain in the back of the upper left leg" was not recovered (persisting for three weeks). Outcome of the other events was unknown. Seriousness reported as non-serious. Follow up needed, further information has been requested.
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| 62 | 2021-06-09 | sensation of foreign body |
Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat...
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Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; lump in throat; 2 asthma flare-ups; face swollen; itching on face, head and around eyes; itching on face, head and around eyes; Occasional waves of feeling very warm; burning feeling around elbows; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 07Mar2021 13:30, at 62 years of age, (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included contrast media allergy, asthma, hypertension, hypothyroidism, glucose tolerance impaired (pre-diabetic) and allergy to erythromycin, cefaclor (CECLOR), penicillin, cefalexin (KEFLEX), neosporine, polysporin, sulfa drugs, eggs, tree nuts, peanuts, fish, shellfish, mushrooms, mustard, chocolate, some melons, raw apples (rashes of hives reactions). The patient didn't receive any other vaccine in the four weeks previous to COVID-19 vaccine. The patient received unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested from COVID-19 post vaccination. On 07Mar2021 at 13:45 the patient experienced itching of tongue, mouth and throat, sometimes lump in throat, 2 asthma flare-ups, face swollen, itching on face, head and around eyes, occasional waves of feeling very warm and burning feeling around elbows. The patient began treatment with famotidine (PEPCID) and diphenydramine hydrochloride (BENADRYL), contacted Doctor's office, then went to ER the day before this report. The physician assistant in ER prescribed 20 mg prednisone daily for 5 days. At the time of the report the reported events had not resolved yet. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-06-10 | feeling drunk, feeling abnormal |
Chronic nonstop dizziness, burning head, brain fog, inability to walk any distance without feeling o...
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Chronic nonstop dizziness, burning head, brain fog, inability to walk any distance without feeling of drugged drunkenness. Off-balance. Onset three weeks after second vaccine, has been steady 24/7 since then.
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| 62 | 2021-06-10 | poor quality sleep, panic attack, anxiety |
had an anxiety attack/the anxiety attack was really out of the ordinary; had a horrible panic attack...
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had an anxiety attack/the anxiety attack was really out of the ordinary; had a horrible panic attack/having hot fiery panic attacks; bad taste in the mouth; couldn't sleep real well/she can fall asleep, but she cant stay asleep, she recalls on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour; her hands are clammy, she is sweating; her hands are clammy, she is sweating; This is a spontaneous report from a contactable consumer (patient herself). A 62-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm on 19Feb2021 (Batch lot number EN6200) (at the age of 62-year old) at single dose for Covid-19 immunization and alprazolam (XANAX XR) orally at 2 mg in the morning at 6 AM and 1 mg at 1 PM (3 mg daily total) for anxiety. She actually had 2 separate prescriptions: one was a Xanax Extended Release 2 mg pill, and the other was a Xanax Extended Release 1mg pill. Relevant medical history included breast cancer from 2006, high blood pressure and cholesterol abnormal. Concomitant drugs included medication for high blood pressure and cholesterol medication. The patient reported that usually her anxiety was managed by medicine, however after the shot, Friday at noon, it was weird she had a horrible panic attack. She also had the panic attack Sunday, yesterday, and a little today. Her anxiety was always controlled prior to the first dose of vaccine but after the shot, it wass not, her anxiety was out of control. She noticed her anxiety incident probably Saturday morning around 6 AM. She did have complications on Friday 19Feb2021, it was a bad taste in the mouth and she couldn't sleep real well at night. She clarified that she can fall asleep, but she cant stay asleep, she recalled on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour. Anxiety was not controlled: it would say being controlled by her medicine as far as intensity of the anxiety attack. On Saturday and Sunday was the biggest anxiety attack, and it was as if she was not even on the medication that's what it felt like, she was not better, the anxiety was still there. Like during the panic attack her hands were clammy, she was sweating, its an anxiety attack, it could be hormones. This was like as if she was not even taking her Xanax XR, she was having hot fiery panic attacks. She just had a physician appointment 2 weeks before the report (and before the vaccination) and everything was fine: "perfectly fine". The outcome of bad taste was recovering, the outcome of sleep unwell was not recovered while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-01-04 | excessive sleepiness |
significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized i...
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significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
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| 63 | 2021-01-06 | anxiety |
HYPERtension, Syncope Hx. HTN and did not take BP meds in the morning. also anxious about immuniatio...
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HYPERtension, Syncope Hx. HTN and did not take BP meds in the morning. also anxious about immuniation. Narrative: History of recent stress test with pending results. pt. c/o lightheadedness while seated in recliner during observation. Per pt., she feels anxious after witnessing another person have a syncopal event. BP 240/98, P 76, R 22, O2 sat. 99% at 0935. RRT in the area so they assessed the pt. and convinced her to go to ED to be checked out. D/c'd per w/c to the ED with RRT. ED reported BP 190/108 in the ED. States she did not take BP meds in the morning and was anxious about her immunization today. ED reported she took her Losartan at 4pm. Discharged from the ED. Recorded on employee medical file on database.
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| 63 | 2021-01-07 | feeling abnormal, anxiety |
20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness...
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20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83. Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.
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| 63 | 2021-01-09 | impaired work ability |
I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I hav...
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I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG
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| 63 | 2021-01-10 | impaired work ability |
severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is ...
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severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is - should I get the #2 dose in light of the robust antibody response to #1. Could it be even worse?? Any information on this?
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| 63 | 2021-01-11 | feeling abnormal |
I felt ok right after the injection but about 2 hours later I started experiencing a pressure headac...
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I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.
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| 63 | 2021-01-12 | impaired work ability, feeling abnormal |
horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat;...
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horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-12 | sleep disorder |
up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the d...
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up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the day on 1/12
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| 63 | 2021-01-13 | feeling abnormal, poor quality sleep, nightmare |
Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches...
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Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.
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| 63 | 2021-01-13 | impaired work ability |
Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work...
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Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work. Started at 4 am, about 18 hrs after vaccine given. Lasted 24 hrs.
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| 63 | 2021-01-14 | impaired work ability | Left arm severe pain, swelling, redness, and hot to touch |
| 63 | 2021-01-19 | anxiety |
Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before le...
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Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before leaving the clinic. She returned 2 hours later with anxiety, hyperventilation and paresthesia. Vital signs showed improvement before symptoms resolved.
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| 63 | 2021-01-20 | feeling abnormal |
Chills-blankets and heater. 5 hours Headache-slept, 8 + hours fatigue-slept and felt run down 2 da...
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Chills-blankets and heater. 5 hours Headache-slept, 8 + hours fatigue-slept and felt run down 2 days
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| 63 | 2021-01-20 | insomnia |
The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection w...
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The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around. On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm. On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it. On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.
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| 63 | 2021-01-20 | restlessness | Pain at injection site, headache, chills muscle aches, joint pain, restless |
| 63 | 2021-01-21 | anxiety |
respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous ...
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respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a
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| 63 | 2021-01-21 | impaired work ability |
Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, cou...
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Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.
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| 63 | 2021-01-22 | sleep disorder, abnormal dreams |
Evening of both doses I had nausea which went away overnight, (also had very strange dreams with fre...
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Evening of both doses I had nausea which went away overnight, (also had very strange dreams with frequent waking up which might have had nothing to do with the vaccine). Second dose nausea the first night, extreme fatigue the second day which was gone by day 3. Headache from day after vaccine until today (5 days later) with more severe headache and dizziness today, but not bad enough to make me not be able to function.
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| 63 | 2021-01-25 | impaired work ability |
Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imod...
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Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imodium, motrin, soft bland diet. Six + episodes of diarrhea in one hour on 1/21/2021 with significant cramping. Went to ER. Received fluids and IV Zofran. CBC and CMP WNL. Stool test also done--negative. Discharged. Severe diarrhea morning of 1/22/2021. Missed work on 1/21 and 1/22. Diarrhea and abdominal cramping continued intermittently. Worked Monday. Stool samples provided. C.Diff negative. Lactoferrin positive. Enteric bacterial panel negative. CT of abdomen scheduled for 1/27/2021
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| 63 | 2021-01-25 | insomnia |
I noted onset of chronic, mild nausea 15Jan21 to present. Eating or drinking usually quells it. Bi...
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I noted onset of chronic, mild nausea 15Jan21 to present. Eating or drinking usually quells it. Bilateral ramped up to the point & noted that I am talk louder than usual and am asking 'What did you say?' frequently with hearing aids. Having to discriminate against tinnitus causes mental fatigue. Marked increase and violence of head tremor (as noted with influenza vaccine) making sleep difficult where head will not stop shaking.
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| 63 | 2021-01-25 | nervousness | Eyes were watery, and red. Also felt shakey |
| 63 | 2021-01-26 | delirium |
Fever, chills, unaware of surrounding, delirium- time frame from approximately 11:15 am to 4:30pm . ...
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Fever, chills, unaware of surrounding, delirium- time frame from approximately 11:15 am to 4:30pm . She was by herself, discovered after a phone call to check on her
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| 63 | 2021-01-26 | feeling abnormal |
428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated short...
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428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated shortness of breath was another symptom that she had from COVID and is continuing somewhat especially when I was a mask for work - but had not put it in the first report). Chills on Friday morning in the middle of night; woke up and my temp was 101.3 and I was feeling bad all day; had headache and went back to bed. Still have pain in hip/knee and joints and those pains got really bad after the vaccine - increased. Doctor vist told me to use Ibuprofen to 3 times a day for that pain. Shortness of breath continues from Covid symptoms and so does the hip/joint pain - it has decreased.
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| 63 | 2021-01-26 | impaired work ability |
About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking ...
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About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.
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| 63 | 2021-01-28 | feeling abnormal |
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest...
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8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-28 | impaired work ability |
starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved -...
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starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved - now dizzy when standing; fatigue - arms feels heavy when taking shower; pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening
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| 63 | 2021-01-28 | loss of personal independence in daily activities, confusional state |
Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle ac...
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Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.
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| 63 | 2021-01-28 | loss of personal independence in daily activities, feeling abnormal |
Muscle had severe burning sensation along with a peculiar feeling, like shards of glass embedded com...
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Muscle had severe burning sensation along with a peculiar feeling, like shards of glass embedded comes and goes but enough to interfere with daily living and movement
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| 63 | 2021-01-31 | feeling abnormal, impaired work ability |
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions...
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The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
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| 63 | 2021-01-31 | nervousness |
Driving home on the 28th she started feeling dizzy, shaky. She says she feels fine when she is lying...
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Driving home on the 28th she started feeling dizzy, shaky. She says she feels fine when she is lying down, but not when upright. She called her doctor and they told her to monitor her symptoms and call if she got worse.
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| 63 | 2021-02-01 | crying |
Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front ...
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Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head; just thinking of a headache; I have been feeling lot of fatigue; crying; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 63-year-old female patient received first dose of bnt162b2 (Unspecified Shot), via unknown route of administration on 15Jan2021 at single dose for covid-19 immunisation (to make sure because I am a caregiver). Medical history included Sjoegren's syndrome and had like chronic fatigue but "that is not a real thing". Concomitant medications included buspirone hydrochloride (BUSPAR) and other medications that she just take a half every other day, it is a small amount. She take 5 mg every other day. She was really taking much. The consumer had lab work, may be not sure 2 to 3 weeks, she has been feeling lot of fatigue. Actually, she did do lab work, it was just like lot of blood work. The consumer stated, "I am having some loss of taste and tightening in the jaw and that was immediately. Tightening is still there and the taste loss seems to happen like a day later. Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head. I guess, just thinking of a headache. I guess, I had headache and crying, it is just nerve-racking." The events started from 15Jan2021 with outcome of not recovered. Treatment received included Advil. Information on the batch number/lot number has been requested.
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| 63 | 2021-02-03 | abnormal dreams, feeling abnormal |
delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get...
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delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get warm even with multiple blankets; severe body aches; severe headache; fever of 101; nausea; thirsty; Symptoms began to abate today (almost 48 hours later) but still fet some foggy thinking; This is a spontaneous report from a contactable other health care professional (patient) and a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELIZ83), via an unspecified route of administration at arm left on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at arm left on 29Dec2020 at 9:30 at single dose for COVID-19 immunization. On Jan2021, the patient reported that 15 hours after second dose, he experienced extreme chills, so cold that it felt like burning ice cubes on his skin, he couldn't get warm even with multiple blankets, severe body aches, fever of 101 F, severe headache, delirious dreams, nausea, thirsty and feel some foggy thinking. The patient outcome of the event was recovering.
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| 63 | 2021-02-03 | anxiety |
hives and rash on arm, patient was alarmed, went and hid in the kitchen, was concerned tablets would...
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hives and rash on arm, patient was alarmed, went and hid in the kitchen, was concerned tablets wouldn't work so gave Benadryl 50mg
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| 63 | 2021-02-04 | feeling abnormal |
Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Jo...
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Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine
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| 63 | 2021-02-05 | anxiety |
Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hour...
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Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep
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| 63 | 2021-02-09 | anxiety |
Patient received 2nd dose of vaccine at 4:15pm. 15min later had left arm pain and numbness on the le...
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Patient received 2nd dose of vaccine at 4:15pm. 15min later had left arm pain and numbness on the left side of body. She seemed very anxious and distressed. did not want labs or imaging, got anxiolytics and Tylenol and symptoms resolved in 30 minutes.----per MD
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| 63 | 2021-02-09 | disturbance in attention, amnesia |
Fever to 101 beginning about 5 hours after injection. Followed that evening by nausea. Fever and n...
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Fever to 101 beginning about 5 hours after injection. Followed that evening by nausea. Fever and nausea persisted all night. Sat AM 1/30/2021 fever had broken, nausea persisted. After a couple sips of tea, returned up stairs to go back to bed: Sudden complete loss of consciousness (syncope), striking right forehead on wooden chair as falling to the floor. Completely unresponsive for 5-10 minutes. Then confused but responsive to voice. Amnesia for events for at least the next hour. Taken via ambulance to ER for evaluation. Trouble with concentration and dexterity for nearly a week. Bruising and tender forehead for more than a week. Left arm injection site became red and itchy 1/31/21, for several days.
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| 63 | 2021-02-09 | impaired work ability |
Chills, fever (100.7), bad headache, weakness, queasy stomach, vomiting (1x), lack of appetite. Fev...
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Chills, fever (100.7), bad headache, weakness, queasy stomach, vomiting (1x), lack of appetite. Fever broke after 2 days, headache lasted 3 days, weakness remained for 5 days, strength improved more each day after that. Returned to work 7 days after vaccination. Appetite returned slowly after 2 days of little to no eating, seems to have normalized now at 2 weeks since vaccination.
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| 63 | 2021-02-09 | insomnia |
Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up...
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Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day. The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.
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| 63 | 2021-02-14 | feeling abnormal, delirium |
Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild...
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Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild headache; pain in my toes feeling like they were broken; chills; sweating. Lasted from 3-7 pm although 4-7 I was in a sound sleep but aware of the symptoms I was feeling. It was a very unusual feeling of unconscious then conscious delirium feeling.
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| 63 | 2021-02-14 | feeling abnormal |
strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my f...
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strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my face. Unsure what the feeling was then realized it felt numb and swollen. tongue felt thick. kinda of like after being numb at dentist office. I also felt kind of tired. I was afraid my throat was going to close up but it didn't. after 1 hour the feeling began to fade. and then went away.
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| 63 | 2021-02-15 | confusional state, loss of personal independence in daily activities |
Report from assisted living. starting 2-15-2021 Client was confused. UTI ruled out. She was wanderin...
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Report from assisted living. starting 2-15-2021 Client was confused. UTI ruled out. She was wandering places she should not. She was in another residents room. She is speaking to staff in another language. VERY confused. Trying to eat her napkin. Unable to dress herself. 2-16-2021 incontinent. not normal for her. unable to stand up. very weak. still very confused. left arm pain. falling asleep mid sentence.
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| 63 | 2021-02-15 | impaired work ability |
My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours ,...
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My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours , and chest pains for 5 days and unable to lay on side while sleeping chest was enflamed, shortness of breath
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| 63 | 2021-02-17 | insomnia |
tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen fe...
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tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-17 | insomnia |
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
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| 63 | 2021-02-18 | anxiety |
Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), ...
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Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021
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| 63 | 2021-02-23 | agitation, irritability, anxiety |
Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vac...
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Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine). She arrived at emergency/symptoms reporting station at 1129 hours. She denied tongue swelling, denied rash, denied difficulty speaking. No rash was seen by medics either. Pt did not have wheezing or stridor. Medics on scene and student medics under the direction of Medics, placed the patient on the monitor. Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16. The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis. Pt became agitated and again remained adamant that medics give her Epi. At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her. Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% . A transport unit was called as precaution and to potentially transport. Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was "irritated" with "everyone talking", that she "can't hear everyone all at the same time", that this is just "too much" and waving her hands in the air. Pt was transported to the ER via Medics for continued care and follow up.
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| 63 | 2021-02-24 | sleep disorder |
I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to ...
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I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep, had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced heavy night sweats where I woke up at 5:15 am being soaked. The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020. My temperature had returned to normal by 6:00 am.
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| 63 | 2021-02-25 | anxiety |
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning s...
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anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
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| 63 | 2021-02-25 | feeling abnormal, amnesia, confusional state | Brain fog. Memory lapses and confusion for several days. |
| 63 | 2021-02-25 | insomnia |
got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomf...
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got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.
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| 63 | 2021-02-26 | poor quality sleep, thinking abnormal, feeling abnormal |
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific....
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Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
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| 63 | 2021-03-02 | anxiety, sleep disorder, nervousness |
2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am hea...
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2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am heart rate 108, no temp scratchy throat 10am diarrhea ; unease and rapid heart rate continue 5pm read about adverse events, called doctor, took Benadryl and began to feel better. 3/2 am communicated with doctor and she advised holding off on second shot, next steps tbd
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| 63 | 2021-03-02 | sensation of foreign body |
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at...
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Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
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| 63 | 2021-03-03 | sensation of foreign body |
Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions....
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Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.
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| 63 | 2021-03-07 | sleep disorder |
HAD WAVES OF NAUSEA STARTING ON THURSDAY FEBRUARY 25TH ,THEN NAUSEA EVER SINCE ,NOW WHEN I GO TO BE...
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HAD WAVES OF NAUSEA STARTING ON THURSDAY FEBRUARY 25TH ,THEN NAUSEA EVER SINCE ,NOW WHEN I GO TO BED I WAKE UP WITH NAUSEA. HAD VIRTUAL VISIT WITH DOCTOR AND SHE PRESCIBED SOME ANTI NAUSEA MEDS AND THIS MORNING WENT TO ER,PRESCRIBED MORE ANTI NAUSEA MEDS . . NOT SLEEPING BECAUSE OF THE NAUSEA. HAVE PC APPOINTMENT TOMORROW .
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| 63 | 2021-03-08 | impaired work ability |
As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did t...
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As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did that in order to sleep better. I did have a lot of stool prior to bedtime, but didn?t think much of it, as I had a lot of water, and thought it might be due to nerves and eating a larger dinner than typical. I went to work, had lunch, and shortly after had explosive diarrhea. I went to clock out, felt weak, and had another episode. I took immodium so I could drive home, had 2 more bouts, took one more immodium, and have not had more. I do feel tender, but am not running a fever. I presume this is not related to the vaccine, but was advised to let you know.
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| 63 | 2021-03-08 | sleep disorder |
I started to get a headache around 6:30 - by 9:30 the whole right side of my head felt as if it had ...
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I started to get a headache around 6:30 - by 9:30 the whole right side of my head felt as if it had a knife going from the base of my skull though my eye out the top of my skull. I was up most of the night with the most severe head pain that I think I've ever experienced. My husband stayed up most of the night with meI had taken 2 Tylenol and a muscle relaxer-Ophedrine? It did nothing for the pain. -I finally fell asleep around 5am and woke at around 7am. The head pain was gone. I had another duller headache the next night but not bad. Also had nasal drip and a few chills but that didn't last long. ( I think I might've had Covid in Feb 2020-I was sick for 4 weeks with strange symptoms that ranged from headaches, extreme nasal drip, dry cough, exhaustion, 3 days of inability to taste food but no fever)
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| 63 | 2021-03-10 | anxiety |
Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO...
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Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO.
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| 63 | 2021-03-11 | feeling abnormal | Light-headed; "foggy brain"; fatigue; headache |
| 63 | 2021-03-12 | anxiety |
While waiting in the lot, patient stated she experienced sensation of heart racing, slight SOB, mil...
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While waiting in the lot, patient stated she experienced sensation of heart racing, slight SOB, mild anxiety. Monitor called RNS and NP. Patient reported to them that s/s were resolving. Vital Signs were monitored. B/P 100/78, HR 72. RN stayed with patient for 20 minutes. Patient ambulated steadily. Denied further s/s. Left lot at approximately 1300. B/P 108/70, HR 72 Respirations 18. Instructed to continue to monitor and to seek medical attention if symptoms return. RN called patient ! 1435. Patient reported no further s/s. Also mentioned that sehhad hypothyroidism and that synthroid dose had been decreased within that past week.
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| 63 | 2021-03-12 | insomnia |
Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at ...
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Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at 11 pm 3/12 and Soothsayer herbal tea at 7 am 3/13. Very tired both shoulders hurt noon 3/13. Took an hour and a half nap from 1-2:30 pm 3/13. Still tired
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| 63 | 2021-03-14 | anxiety |
Monitored pt as she was "worked up" about her husband who was being monitored as well post vaccine a...
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Monitored pt as she was "worked up" about her husband who was being monitored as well post vaccine administration. vital at 0930, 175/88, 107, 16, 99% on RA. Pt refused any further treatment or monitoring and went home via ambulation w/ her husband at 0935
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| 63 | 2021-03-14 | feeling abnormal |
Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minut...
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Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minutes of the queasiness, patient started to feel dizzy and nauseous. Patient endorsed feeling "not quite right". Patient was brought over to paramedics for further observation. VS taken over the course of ~1 hour prior to patient being transferred to ED. Transport occurred on date of vaccination. On post-vaccine Day #1, pt continued to endorse some dizziness. Also noted to have SOB, headache, and mild body aches with a brief episode of chills. On post-vaccine Day #2, pt still felt SOB, more upon exertion. Pt had to use rescue inhaler every 4 hours, which helped pt "breathe and relax a little bit."
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| 63 | 2021-03-14 | feeling abnormal |
At time of vaccine administration, patient experienced a metallic taste in her mouth as she has in t...
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At time of vaccine administration, patient experienced a metallic taste in her mouth as she has in the past with other medications. Approximately 5-10 minutes after the vaccine, she felt a "prickly" feeling starting at the head moving down to the arms and down to her trunk. It was most prominent in her hands. Patient denies any shortness of breath, swelling, rash, or any other respiratory issues. Patient was monitored for 30 minutes after vaccine administration and "prickly" symptoms persisted.
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| 63 | 2021-03-14 | feeling abnormal |
Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fin...
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Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fine and left. She returned to the clinic an hour (or so later) reporting feeling flushed and "off". We had patient sit back down and began observing again. Patient developed a cough which became progressively worse. We monitored her O2 sat, pulse and BP. At 3:30pm Patient received epinephrine 0.5mg IM and Diphenhydramine 50mg IM. EMS was called. Patient's cough subsided. She refused transport to the hospital AMA. Patient left the clinic on her own, accompanied by her husband. ;"
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| 63 | 2021-03-14 | impaired work ability |
I started to experience a problem with my left eye about 6 hours after I received the vaccine. I cou...
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I started to experience a problem with my left eye about 6 hours after I received the vaccine. I could see small bolts of white light is the far outside corner of my eye. I first attributed it to an ocular migraine, but those usually only last maybe an hour. The next morning I could still see the bolts of light which were very distracting. I called in sick to work and went to see an eye doctor. He diagnosed me with a PVD (posterior vitreous detachment). It may have been coincidental, however since it occurred on the same day I received the first vaccine, I was advised to report it by V-safe who was doing periodic follow up through texts.
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| 63 | 2021-03-14 | sleep disorder, crying |
Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Bo...
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Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Both calves felt weak. Extreme fatigue. Increased ear ringing. Sinus and head pressure. Slight queasiness. When the shot was first given, I had immediate pain at the injection site and up my neck. As the day progressed I felt tired, achy all over. The burning, stinging pain increased, in both arms and upper back. It seems worse at night and wakes me up. It is severe enough that it makes me cry. I have used regular strength Tylenol, Regular strength Advil and Allegra, as treatment. The burning pain continues. So does the muscle aching and fatigue.
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| 63 | 2021-03-15 | insomnia |
Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous repo...
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Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered. Information on the Lot/Batch number has been requested
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| 63 | 2021-03-16 | anxiety, sleep disorder, feeling abnormal |
I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hi...
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I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction: metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared. This quieted down after about 10 minutes, but then I got "hit" again, a few minutes after that. This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared. I was under observation for 45minutes before they let me drive home (just 4 miles away). Once I got home, I felt extremely exhausted and foggy headed. This lasted for about 6 hours, and then it began to lift. That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around. The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.
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| 63 | 2021-03-17 | impaired work ability, sleep disorder |
I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that...
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I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that night but I couldn't hardly slee because of the pain. I had to call out because I could hardly walk. Steroid dose was for 9 days and after wards it resolved.
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| 63 | 2021-03-18 | agitation | About an hour after the vaccination the patient reported feeling agitated |
| 63 | 2021-03-18 | disorientation, anxiety |
Patient received the COVID 19 vaccine (Pfizer) at 1700. She became anxious. Nurses lied her down on ...
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Patient received the COVID 19 vaccine (Pfizer) at 1700. She became anxious. Nurses lied her down on a cot where she had a vasovagal response with loss of consciousness. Pt was disoriented x 2minutes. VS: BP 124/80, HR 86, O2 sat 100% room air, RR 18. Paramedics were called to evaluate patient. She was medically cleared by paramedics. Pt had a friend drive her home. Pt was stable when leaving.
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| 63 | 2021-03-18 | disorientation, feeling abnormal, anxiety |
When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. ...
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When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours. I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.
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| 63 | 2021-03-18 | feeling abnormal |
Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morni...
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Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morning started to feel terrible - sore arm, headache, severe body aches, fever, chills, nausea. Continued through to Thursday. Pt started to feel intermittent SOB, difficulty with getting in air. This subsided after some time. NO rash, hives, tight airway, vomiting. Patient reports today feels a little better but entire body still has burning sensation. Going to Urgent care for evaluation.
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| 63 | 2021-03-18 | feeling abnormal | Feels super warm and abnormal. Felt better after sitting or 5 minutes without any interventions |
| 63 | 2021-03-18 | nervousness |
Pt received vaccine at 1231 and within 10 minutes reported feeling "shaky" with a warm tingling feel...
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Pt received vaccine at 1231 and within 10 minutes reported feeling "shaky" with a warm tingling feeling all over. She was moved via wheelchair to an observation area. Initial vitals at 1245 98% on room air, 100 HR, BP 157/94. Pt stated she was feeling better and was then escorted at 1330 to the bathroom via wheelchair. Upon her return, she reported now experiencing chills and was shaky. Vitals at 1340 were 176/86, 96%, and HR 99. Pt denied SOB, fullness in mouth, and itchiness. Further vitals: 1357 175/85, 96%, HR94. 1405 183/105, HR 107, 97%.; 1406 173/80, HR 104, 97%. It was determined by RN that 911 would should be called to further evaluate the patient. Patient was taken via EMS to the hospital with her husband in attendance.
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| 63 | 2021-03-20 | anxiety |
Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vit...
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Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vitals taking, pt reassured, symptoms resolved within minutes
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| 63 | 2021-03-21 | feeling abnormal, feeling drunk |
Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or...
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Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or sudden rise in blood pressure. Then severe vertigo set in, everything started spinning and nausea set in. Waited for 30 minutes and vertigo was better, but not totally gone, but nausea was still there. Left facility and nausea abated after 1.5 hours. Vertigo continued for 48 hours but fairly mild. Caused me to walk like a drunk person but no dizziness any more. Then at 10:30 PM torso broke out in hives that lasted about one hour. No hives on arms and legs.
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| 63 | 2021-03-21 | feeling abnormal |
Brain fog (forgetfulness, wondering what I needed to do), unsteadiness when walking and on stairs; n...
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Brain fog (forgetfulness, wondering what I needed to do), unsteadiness when walking and on stairs; normally walk quickly and on stairs, vision was off a bit more. Reactions started 12 hrs. after receiving shot and the 2nd day. 3rd day was fine.
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| 63 | 2021-03-23 | anxiety, sleep disorder |
This is my second report, I had received my 2nd Pfizer vaccine on 2/23/2021.On 2/24/2021I was a litt...
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This is my second report, I had received my 2nd Pfizer vaccine on 2/23/2021.On 2/24/2021I was a little achy and that night felt a little nauseous On 2/25/2021 I began to experience strange waves of nausea during the day. . that night I continued with the nausea and for the next few days had stomach issues. then that Sunday night i woke up with strange nausea and discomfort .I was having this every night Some days I would be fine and others would feel little queasy on and off. I ended up at the ER on Monday March 8th ,they ran blood and urinalysis and no other tests . They told me the nausea would go away. I have been to my GP twice and one virtual visit . I have been on pepcid , zofran which didn't help .and now prozac and xanax at night . I may have one night that is good and then the nausea will return. I was not sleeping or eating and was getting anxiety from the nausea. My doctor thought it was a side effect from the vaccine and the ER doctor said its so new they just didn't know. This is week 4 now and I am headed to a gastroenterologist this week . I am a healthy 63 year old with no underlying health problems . I have had stomach aches and nausea before but this is definitely different.
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| 63 | 2021-03-23 | anxiety |
Client verbalized feeling anxious before/after receiving the vaccine. Client was evaluated by onsit...
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Client verbalized feeling anxious before/after receiving the vaccine. Client was evaluated by onsite Sheriff Fire Rescue. Client was released to go home at 12:17 pm after symptom was resolved per Fire Rescue.
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| 63 | 2021-03-23 | fear, depressed mood |
Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body starte...
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Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body started to be achy. That was followed by bilateral eye pain so that the only comfortable thing to do was to put on eye shades. I was exhausted by the afternoon. I had absolutely zero energy to do anything but lie down. By Sunday morning every inch of my skin was sensitive, every joint was sore and every muscle group in my body was painful. The symptoms from the previous day remained; head and eye pain. I used both tylenol and advil a few times but without relief. Monday my body/joints were still achy and I was super tired but not like the previous 2 days. I became very depressed and fearful that it would not let up. Today is Wednesday and its the first day I feel like myself again although I did have to take a nap 3 hours after I woke up today. Body still aches but nothing like it was
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| 63 | 2021-03-23 | hallucination |
Severe headaches, tiredness, fatigue, difficulty walking w/o assistance, lightheadedness, hallucinat...
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Severe headaches, tiredness, fatigue, difficulty walking w/o assistance, lightheadedness, hallucinations that disappeared 3 nights after the vaccination.
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| 63 | 2021-03-23 | sleep disorder |
Feverish, sweating, mid- level headache, and at 8 pm muscle pain especially in breasts, jaws and ev...
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Feverish, sweating, mid- level headache, and at 8 pm muscle pain especially in breasts, jaws and every joint that has arthritis was very painful. Couldn?t sleep until 3 a.m... Woke up at 5 a.m. and all symptoms were gone. None since.
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| 63 | 2021-03-24 | confusional state |
Began feeling very tired and slightly confused. Left work one hour, one home I had a slight fever o...
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Began feeling very tired and slightly confused. Left work one hour, one home I had a slight fever of 99 so I took Tylenol and tried to sleep. Woke with a headache and cold not get warm all night.
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| 63 | 2021-03-24 | nervousness, insomnia |
Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating...
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Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating really hard/pounding chest; Weakness; Fast heartbeat/Pounding chest; Lightheadedness; Insomnia; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reported). A 63-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 at unspecified route in left arm on 08Mar2021 11:30 as a single dose (at the age of 63 years) at for COVID-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing severe allergy , drug hypersensitivity from an unknown date and unknown if ongoing severe allergy , dysphagia from an unknown date and unknown if ongoing , ongoing Sjogren's syndrome diagnosed 33 years ago , ongoing systemic lupus erythematosus diagnosed 3 years ago , ongoing headache , ongoing intervertebral disc degeneration diagnosed with this about 15 years ago , ongoing fibromyalgia diagnosed 10 years ago , Meniere's disease from an unknown date and unknown if ongoing , supplementation therapy from an unknown date and unknown if ongoing Vitamin c (Verbatim): recommended by dentist bone health and teeth. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from 2020 and ongoing; vitamin d3 (VITAMIN D3) taken for hypovitaminosis from 2019 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for hypovitaminosis from Apr2020 and ongoing; timolol (TIMOLOL) taken for glaucoma from 2011 and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for dyspepsia from an unspecified start date and ongoing; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) taken for fibromyalgia from an unspecified start date and ongoing; cetirizine hydrochloride (GENERIC ZYRTEC) taken for hypersensitivity from 2011 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; olanzapine (OLANZAPINE) taken for bipolar disorder from an unspecified start date and ongoing; docusate sodium (COLACE) taken for constipation from an unspecified start date and ongoing; lactulose (GENERLAC) taken for constipation from 2018 and ongoing; acetaminophen (TYLENOL GENERIC) taken for headache, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for intervertebral disc degeneration, headache from Dec2020 and ongoing; triamcinolone diacetate (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) taken for rash from 2018 and ongoing; meclizine hydrochloride (MECLIZINE HYDROCHLORIDE) taken for dizziness, start and stop date were not reported. The patient experienced heart was racing, her heart was beating really hard/pounding chest on 08Mar2021 with outcome of recovered , pale and shaky on 09Mar2021 with outcome of recovered weakness on 08Mar2021 with outcome of recovered , fast heartbeat/pounding chest on 08Mar2021 with outcome of recovered , lightheadedness on 08Mar2021 with outcome of recovered , insomnia on 08Mar2021 with outcome of unknown , blood pressure bottomed out on 09Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 'bottomed out' on unspecified date 09Mar2021, heart rate: 95, heart rate: 98-101, heart rate: fast. Therapeutic measures were taken as a result of , insomnia. No vaccines administered on same date with the Pfizer vaccine. No vaccinations within four weeks prior to the first administration date. No ER visit or physician office visit reported.
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| 63 | 2021-03-24 | sleep disorder |
fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barel...
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fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barely move it or sleep on it, tired feels like a mild flu
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| 63 | 2021-03-25 | impaired work ability |
same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was ...
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same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was unable to work the follwoing 2 days due to severity oif her symptoms. She also reports a mild rash at injection site.
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| 63 | 2021-03-25 | loss of personal independence in daily activities |
I began to experience very painful nerve pain in my body, most noticeable in my feet area making it ...
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I began to experience very painful nerve pain in my body, most noticeable in my feet area making it painful to walk. I had been exercising and after the Pfizer covid vaccine shot, it hurt too much to exercise.
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| 63 | 2021-03-25 | sensation of foreign body |
Throat swelling, tongue tingling Narrative: Code 99 called to the second floor auditorium where thi...
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Throat swelling, tongue tingling Narrative: Code 99 called to the second floor auditorium where this simply received her second coronavirus vaccine. Approximate 10 minutes later she developed tightness around her neck and her tongue started to swell. No chest pain or shortness of breath. No rash. Didn't have a problem with her first vaccine. Epinephrine 0.3 mg 1M and Benadryl 50 mg 1M given. The patient started to feel better. Tip of the tongue was slightly swollen and red. Patient spoke in normal sentences. No stridor. Appears well and resting completely in the wheelchair. Brought to the emergency department for further evaluation and observation. ED provider note: 62 yo FEMALE w/ Wo multiple medication allergies p/w possible allergic reaction. Pt recieved her second covid vaccination today @ approxately 1330 and reports nearly inmediate onset of sensation of "like a pill is stuck in your flu-oat" and feeling like her throat was swelling. Then states that she developed an abnormal sensation on the tip of her tongue described as tingling and swelling. Denies any n/v, abdominal pain, sob or difficulty breathing. Pt received 0.3 mg of 1M epi as well as 50 mg of 1M benadryl. Pt observed in ED for 6hrs,She was given steroids and Pepcid in the ER. She has an EpiPen at home due to an allergy to bee stings. I told her that while a recurrence of her reaction is she should pay close attention to any new or worsening symptoms and return to the ER immediately for chest pain, shortness of breath, oral swelling, GI symptoms, or any other new symptoms she develops that she is concerned about. She expressed understanding of this plan. She was given a short course of steroids and instructions for scheduled Benadryl for the next 24 hours. Other Relevant History.
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| 63 | 2021-03-25 | sleep disorder |
Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd...
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Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd vaccine & got worse through the night. Couldn?t sleep, left arm & left side of neck were sore & hurting in the beginning, then spread to my entire body. (1st vaccine 3 weeks before, no problems except my left arm was sore for a day.) Took ibuprofen & alprazolam before getting in bed & it seemed to help for a short time. My nerves felt like they were on top of my skin. Didn?t sleep much at all, maybe couple hours. Now, 3pm the next day, I?m still very sore, tender all over my body.
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| 63 | 2021-03-26 | anxiety, nervousness |
After adminstaration of medication, patient had light headedness, nervousness, anxiety induced sympt...
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After adminstaration of medication, patient had light headedness, nervousness, anxiety induced symptoms. Paramedic came and took vitals signs and ekg vital signs are stable . As her smptoms dessipate she was release by the nurse.
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| 63 | 2021-03-26 | restlessness, sleep disorder, agitation |
Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest...
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Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine. Should I get the 2nd vaccine, scheduled for 4/15?
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| 63 | 2021-03-27 | impaired work ability |
Fatigue: I had Covid last summer and experienced fatigue for several months. I felt better by the F...
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Fatigue: I had Covid last summer and experienced fatigue for several months. I felt better by the Fall but fatigue returned after my 2nd dose of the vaccine. Unable to work for normal 8-9 hours/day. This has been for the past two months. Symptoms seem to be getting better slowly. Tinnitus: I had mild tinnitus prior to the vaccine but it has increased. No change in the past two months.
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| 63 | 2021-03-27 | loss of personal independence in daily activities, impaired work ability |
severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss i...
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severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss intermittent left eye for 5 minutes at a time ( 5 events over one month), continued to this day intermittent diplopia vertical , with blurring vision and eye fatigue , general fatigue with ADL ( missed multiple days of work), bouts of tachycardia and palpitations ( slowly abating over 6 weeks ) , original neck pain and headache severe in first 2-3 weeks especially after second vaccine 1/29/21 lot number EL3246. multiple MRI's done brain ( white matter and demylination dating back to before 2015) and cervical and thoracic spine showing existing disc disease all old , neurology work up was done for MS and it was ruled out. visual disturbances persist and neuro-ophthomologist appointment schedule for mid april .
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| 63 | 2021-03-28 | confusional state |
Patient recieved the vaccine and her husband stated his wife didnt "no where" she was and was confus...
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Patient recieved the vaccine and her husband stated his wife didnt "no where" she was and was confussed & dizzy. Patient appeared diapheretic. Onsite EMS was called at 2:42pm HR 64 BP 76/47 Blood pressure did not recover by 2:58 pm and refused transport to the hospital.
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| 63 | 2021-03-28 | feeling abnormal |
Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (...
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Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)
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| 63 | 2021-03-28 | feeling abnormal |
I am still weak and tired 5 days later. I nap (highly unusual for me) and feel better for a little ...
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I am still weak and tired 5 days later. I nap (highly unusual for me) and feel better for a little while but if I do anything I get weak and tired again. I get feeling fogginess like I'm lost in a fog and can't even function. Then I lay down and I get feeling better. I keep thinking I'll shake it and get well but this has been going on for five days now. Also I have never had a headache in my life, but I am getting recurring small headaches. And I just feel weird, not right.
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| 63 | 2021-03-28 | feeling abnormal |
bad headache, high fever, body ache, no energy, slept all day/night Now brain fog , blurred vis...
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bad headache, high fever, body ache, no energy, slept all day/night Now brain fog , blurred vision low energy
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| 63 | 2021-03-28 | excessive sleepiness, feeling abnormal |
Please know that this point there is no emergency, but I am furious at the enormous side effects I'v...
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Please know that this point there is no emergency, but I am furious at the enormous side effects I've endured on the 1st and 2nd vaccine My 1st vaccine was March 5th at 10:30 am . Next day I had a slight fever and was exhausted all day long. I had to keep laying down after being up for an hour. 5 days passed and I was in the grocery store and my legs were on fire and I had huge Welts -hives all up-and-down my legs . I started to faint and the woman in the bakery sat me down until it passed. I had a headache and a slight fever after that . I also had a enormous sneezing fits, of which there was no apparent trigger. At the time I just chalked it all up to allergies or something un related to the vaccine because so many days had passed. I received my 2nd vaccine on March 26th at 8:00 p.m. at the Farm stadium. The next day my arm was a little sore, nothing unusual. The following day I was a little tired again nothing unusual. The 3rd day ( Mar 29) all hell broke loose. I got the hives all over the place, I could not stop sneezing . I've got a massive headache, and I can barely stay awake over an hour without taking a nap. I am absolutely miserable! I wish I had never taken the 2nd vaccine. This may not be life-or-death, but it sure as hell sucks. I wouldn't recommend the vaccine after this experience . And if it's anything like my 1st vaccine, I've got a week of this to endure
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| 63 | 2021-03-28 | nervousness, anxiety |
runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare...
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runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare; facial neuropathy flare; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6201, expiry date not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 08:30 at a single dose for COVID-19 immunisation. Medical history included facial neuropathy, sleep apnea from 2003, and Guillain-Barre syndrome from 2001. Patient said she had Guillain-Barre syndrome 20 years ago and has residual neuropathy from that. There were no concomitant medications. Patient have not had any other recent vaccinations or started any new medications. Patient called about the Pfizer COVID-19 vaccine shot, as she was supposed to call about possible side effects, to report. She said that she had her first dose of the vaccine on 25Feb2021 and hasn't had her second yet. She said that the first dose was injected in the morning, around 08:30AM. She said that there was a sticker on her vaccine card that says mRNA Pfizer-BioNTech, and (withheld), she didn't know what that means. She said actually that was abbreviation for (withheld), her vaccine provider. Her side effects included fatigue on an unspecified date in 2021, which she thinks a lot of people do have. She didn't know if this was available but she was hoping to advice about getting her second shot. She has had a runny nose since day after getting the shot, so since 26Feb2021, it hasn't stopped. She was not saying this was from the shot, it could be chronic runny nose, but it didn't stop. She said that the worst thing she was calling about was she has facial neuropathy flare in 2021, described as slight facial neuropathy which felt like it has flared since the shot. She was calling because she was nervous about second shot in 2021, since it flared with the first one a bit. She didn't want this to get worse, she can live with it currently, but she has heard people have more problems with the second dose and she didn't want to risk full blown neuropathy. She has done no treatment for the neuropathy, but for the runny nose there were a couple nights she took Benadryl and today she took Claritin, so put that she has taken sporadic over the counter stuff. No further details provided about Claritin or Benadryl. She has been experiencing continuous runny nose, flare of facial neuropathy, and fatigue. She was worried in getting the 2nd dose in 2021 and wanted to have recommendations as her doctor was reluctant in giving an advice whether she may have the 2nd dose or not. The patient reported that facial neuropathy flare as serious medically significant while the other events was non-serious adverse events. Patient was advised by the Pfizer colleague of the overall safety summary that indicated throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19. The outcome of the events facial neuropathy flare, fatigue, nervous and worried was unknown. The event runny nose was not recovered.
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| 63 | 2021-03-29 | confusional state |
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Letharg...
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Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: clamy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
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| 63 | 2021-03-29 | excessive sleepiness |
Woke up at 3am on second morning after vaccine with extreme dizziness and nausea. Continued to have...
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Woke up at 3am on second morning after vaccine with extreme dizziness and nausea. Continued to have dizziness, nausea, and dry heaves until following day. Could do nothing but sleep. Lightheadedness continued through the next day after that but nausea passed.
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| 63 | 2021-03-30 | impaired work ability, loss of personal independence in daily activities |
Sore arm for 1/2 day after shot was expected. However, one week after injection (3/39/21), I became ...
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Sore arm for 1/2 day after shot was expected. However, one week after injection (3/39/21), I became dizzy. The next morning (3/30/21), I was extremely dizzy, very nauseous, and had a severe headache. I was hardly able to get out of bed, and unable to work that day. Symptoms lasted until the morning of 3/31/21.
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| 63 | 2021-03-30 | nervousness |
0650: Pt in observation after receiving 2nd dose of Covid vaccine. Husband present. Pt states felt a...
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0650: Pt in observation after receiving 2nd dose of Covid vaccine. Husband present. Pt states felt a "rush" , urge to swallow over and over, legs shaky, feeling claustrophobic. Hx of feeling similar when having shell fish or receiving contrast. Water given feeling somewhat better. BP 175/93, HR 75, O2 sat 100% 0655: feeling increase salivation and urge to swallow. 0700 Benedryl 25mg po given with water. BP 157/76 HR: 68 02 sat 100% 0715: Pt states feeling much better, salivation and urge to swallow gone. BP 139/63 HR 67, 02 sat 99% 0725 Pt states no further c/o of anything. Ambulated with husband to car.
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| 63 | 2021-03-31 | anxiety |
Client is observed in Observation area x30 min, didn't complain any symptoms. Client went back to he...
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Client is observed in Observation area x30 min, didn't complain any symptoms. Client went back to her vehicle, and c/o lightheadedness and anxiety. Vital signs taken: BP 119/68, HR 85, SpO2 99%, RA, RR 18/min. Client is provided with hydration and snacks. Client is directed to lay down in her car seat, open the car windows and turned on AC, and observed for another 25 min. Client stated "My energy is back". Client refused 911 services, and stated she could drive home. Client left POD at 10:46am without symptoms.
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| 63 | 2021-03-31 | anxiety |
pt. c/o feeling little tightness on her throat. She is able to swallow. seems anxious resolving. ...
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pt. c/o feeling little tightness on her throat. She is able to swallow. seems anxious resolving. Hx - anxiety
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| 63 | 2021-03-31 | feeling abnormal |
Pt arrives to the observation area after receiving her vaccine. she states she has known vertigo fo...
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Pt arrives to the observation area after receiving her vaccine. she states she has known vertigo for some time and "feels loopy in the head after the injection" 1329 BP 140/ 79 HR 60 Oxygen sat 98% room air given water to drink 1335 BP 145/79 HR 58 oxygen 99% room air patient tolerating oral fluids 1350 BP 152/82 HR 57 oxygen 100% room air pt feeling better she states that her head is back to normal, she tolerated two bottles of water 1400 pt was released from observation and escorted to the exit with staff her daughter was in the parking lot to take her home
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| 63 | 2021-04-01 | feeling abnormal, anxiety |
Received the Covid-19 vaccine. She reports symptoms of Other: Shortness of breath and "feeling funny...
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Received the Covid-19 vaccine. She reports symptoms of Other: Shortness of breath and "feeling funny.". I have observed patient feeling anxious and uncomfortable. Treatment/intervention /vitals taken: B/P 124/82, pulse 104, RR 16, Oximetry 98%. Recheck p- 82, oximetry 100%. Lungs were clear bilaterally. Patient stating that she was feeling much better. Offered her water to drink. Staff remained with patient until she was feeling comfortable enough to leave. When leaving, she stated that she was fine and needed no assistance. Ambulatory.Agency report submitted: yes Agency Report number:
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| 63 | 2021-04-01 | insomnia |
Nausea, so far three days Sweats and chills. Temp reading normal Severe headache 2 days Sleeplessnes...
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Nausea, so far three days Sweats and chills. Temp reading normal Severe headache 2 days Sleeplessness four nights Extreme fatigue
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| 63 | 2021-04-01 | loss of personal independence in daily activities |
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso...
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rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-04-02 | feeling drunk |
Patient DOB 9/6/57 received her first Pfizer Covid vaccine, then became dizzy, "I feel like I am dru...
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Patient DOB 9/6/57 received her first Pfizer Covid vaccine, then became dizzy, "I feel like I am drunk" Patient laid down on an exam table, her husband brought her cookies and water, Patient stated that it had been several hours since she last eaten, left the clinic with her husband as an escort without incident
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| 63 | 2021-04-02 | insomnia | Daily headaches, nightly insomnia |
| 63 | 2021-04-03 | feeling abnormal, amnesia |
1st shot was similar, it felt like something popped and my sinuses got crazy, my eyes got watery and...
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1st shot was similar, it felt like something popped and my sinuses got crazy, my eyes got watery and swollen, my throat was like a stiff neck, my head hurt so bad i was taking tylenol every 4 hours, at night i got a fever and my husband said i was crying for a blanket, I think I might have gone back to when i was at the hospital, I don't know, we both couldn't walk or move everything hurt so bad. The second shot was worse than the first.
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| 63 | 2021-04-05 | emotional distress |
Within 15 seconds of second Pfizer CV19 vaccination, given at appropriate interval from 1st dose, pa...
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Within 15 seconds of second Pfizer CV19 vaccination, given at appropriate interval from 1st dose, patient experienced cough. I noted that the patient coughed as she exited the vaccine area to the observation area that was manned by a Registered Nurse. The RN came to the vaccine area to ask me to help with the patient while she waited in the lobby with another RN. The patient was sitting in a chair, flushed, distressed, experiencing shortness of breath and repeatedly coughing. EMS was already called. I pulled up 0.3mg of epinephrine which was administered IM in the right lateral thigh and 25mg of diphenhydramine 25mg which was administered IM into the upper left deltoid, the opposite arm from the vaccination. EMS arrived and took the patient to the emergency room approx. 1 mile from the clinic. She received methylprednisolone 125mg IV, famotidine 20mg IV, and nebulized race-epinephrine upon arrival. She was discharged home with prescriptions for prednisone 20mg daily x 5 days and an Epipen.
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| 63 | 2021-04-06 | feeling abnormal |
63 y/o female with PMH of GI issues, s/p ileostomy c/o pain (4/10) in her left shoulder and left SCM...
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63 y/o female with PMH of GI issues, s/p ileostomy c/o pain (4/10) in her left shoulder and left SCM. Pt was assessed by clinical leads and a heat pack was applied to her left shoulder. Pt was re-assessed 2 minutes later to monitor symptoms. Pt appeared diaphoretic, pale, complaining of dizziness + nausea. Ice packs were applied to her neck and forehead and EMS was called to monitor vitals, lay pt on a stretcher, 2L O2 via nasal canula. Pt reported "feeling awful" and did not respond to any questions, pt maintained consciousness throughout the entire encounter. Pt was attached to a monitor and a 12 lead EKG was obtained that showed evidence of a wide QRS, new right bundle branch, prolonged QT and T wave changes. Pt denied any cardiac history or history of abnormal EKGs or similar prior experiences. She was immediately transported via EMS to the Hospital Emergency Room for further evaluation, pt gave consent for transport. Pt denied notifying / calling a family member or friend to inform them. Denies chest pain, LOC, SOB, respiratory distress, vomiting, itchiness, erythema, swelling, HA, similar prior experiences PMH: weak pelvic floor, IBS, imbalanced gut flora, ileostomy for unknown reason - DENIES history of: cardiac issues, pulmonary issues, diverticulitis, cancer, autoimmune conditions (ulcerative colitis, crohns) Surgical History: ileostomy, C-section Meds: Linzess, Motegrity, Baclofen, Liothyrozine Vaccine was administered at 11:48 am in the left deltoid. Pt began experiencing symptoms at ~ 12:03pm. General: A&Ox3 HEENT: NC/AT, EOMI, PERRL, airway patent, no trismus MSK: tenderness to left SCM, neurologically intact b/l, brisk capillary refill b/l, radial pulse 2+ b/l, full ROM b/l, 5+ strength b/l Skin: diaphoretic, pale Pulmonary: clear to auscultation b/l Vitals: @12:09: BP: 74/52, HR: 53, SpO2: 96% RA, @12:12 2L O2 NC @12:13: BP: 106/73, HR: 72, SpO2: 97% 2L NC @12:15: SpO2: 99% 2L NC @12:16: BGM: 118 @12:20: BP: 112/77, HR: 69, SpO2: 100% 2L NC
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| 63 | 2021-04-06 | sleep disorder |
Horrific pain in left arm, shoulder, neck every day since the first injection. Pain is 24/7, ongoi...
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Horrific pain in left arm, shoulder, neck every day since the first injection. Pain is 24/7, ongoing, causes lack of sleep, severe discomfort, inability to function
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| 63 | 2021-04-07 | anxiety |
Pt reports difficulty swallowing, numbness to lips and mouth area, sensation of eye swelling. Pt ap...
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Pt reports difficulty swallowing, numbness to lips and mouth area, sensation of eye swelling. Pt appears anxious. Medics on site for evaluation; VSS. Pt left AMA.
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| 63 | 2021-04-07 | feeling abnormal |
Fever, chills, very sore arm, brain fog, achy, nauseous, back pain, very tired. Went to bed at 6 pm...
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Fever, chills, very sore arm, brain fog, achy, nauseous, back pain, very tired. Went to bed at 6 pm. Woke up at 6:30 am with all symptoms gone, except a one degree fever, brain fog & tired. Took 500 mg Tylenol at 1 pm on 4-7-21. Took two naproxen 220 mg each at 9 pm on 4-7-21. Took Tylenol 500 mg at 9 am 4-8-21.
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| 63 | 2021-04-07 | impaired work ability |
Only initial side effect following both injections was moderately sore arm and fatigue. Following 2...
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Only initial side effect following both injections was moderately sore arm and fatigue. Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes. Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital. Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV. MD gave me Antivert. Didn't work. Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.
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| 63 | 2021-04-07 | sleep disorder |
First day a little sore arm,(Monday) The second day was BAD.(Tuesday) As the day went on it got wo...
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First day a little sore arm,(Monday) The second day was BAD.(Tuesday) As the day went on it got worse. That evening I did not sleep all night. I was having very intense throbbing pain from my wrist, up my right arm (same arm as the shot was given), up the right side of my neck, pain down my right side of my back and into my lung area. The pain just spread until it was on a scale of 1-10 it was an 11. It also spread to my lower back. The next day,( Wednesday) I still had all of the pain. Thursday I just have soreness in my upper shoulder blade area. This was very scary! I even took some aspirin incase of blood clotting. Tylenol did nothing. If I would have had a very strong pain pill I would have taken it. Now I am afraid to get my second shot which is scheduled for April 26th. I need some guidance from you on this.
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| 63 | 2021-04-08 | excessive sleepiness |
Started with Chills, headache, aches and pains in joints and muscles. Body feeling heavy. Got up...
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Started with Chills, headache, aches and pains in joints and muscles. Body feeling heavy. Got up to use the restroom around 2:45am and got nauseous and very hot and passed out for about 15 seconds. Woke on the floor which cooled me down, drank some water and went back to bed. Next morning I got woozy and had trouble standing. Slept most of april 8. April 9th felt better.
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| 63 | 2021-04-08 | nervousness |
Cold chills, sinuses clogged & running, heart fluttering, head soreness, ringing in my ears, exhaust...
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Cold chills, sinuses clogged & running, heart fluttering, head soreness, ringing in my ears, exhausted feeling shake feeling.
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| 63 | 2021-04-08 | sleep disorder |
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Headache-Sev...
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Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Headache-Severe, Systemic: Unable to Sleep-Severe, Additional Details: Day after immunization, Tuesday, patient reports she had severe pain at injection site, arm,back and neck,including headache. There was no inflammation or redness at sites of pain or injection site. She took aspirin and slept most of the day. On Wednesday morning, still had pain, was not as severe. Today, Thursday, some pain in back still, but much better. She is mostly concerned as to whether or not to receive the second shot in a few weeks. She would like someone a follow up call
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| 63 | 2021-04-09 | feeling abnormal |
Event woke her up; feeling really bad; kind of sick at her stomach; fatigue, tired; really nauseous;...
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Event woke her up; feeling really bad; kind of sick at her stomach; fatigue, tired; really nauseous; Really, really sick; This is a spontaneous report received from a contactable consumer (patient). This contactable 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration in the right upper arm on 06Mar2021 at 13:30, reported as about 13:30 to 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2001 and ongoing, high blood pressure from 2001 and ongoing, and chronic obstructive pulmonary disease from 2001 and ongoing. Concomitant medications were not reported; the patient stated she'd been taking them for years and they were not relevant to these events. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on 06Mar2021 around 13:30-14:00. She reported being really, really sick later that day on 06Mar2021 and called to inquire if this event could be related to the vaccine and asked if she had to get the same type of COVID-19 vaccine for both doses, or if she could get a different manufacturer's COVID-19 vaccine for the second dose. She reported really, really sick initially onset around 19:00-20:00 on 06Mar2021 and continued for 2 days, until around 08Mar2021 then she felt better. Starting 09Mar2021 around 19:00-20:00 she started feeling really, really sick again like she was on 06Mar2021. She was feeling really bad, kind of sick at her stomach, really nauseous, fatigued, and tired. The event woke her up around 06:30 on 11Mar2021. She further reported the ongoing event is about the same as initial onset, persistent. Regarding bloodwork performed about a month or so before being administered BNT162B2, approximately Feb2021, she reported that they had corrected her low iron and low B12. The events did not require hospitalization. The clinical outcomes of really, really sick, feeling really bad, kind of sick at her stomach, fatigue, tired, nauseous and event woke her up were not recovered. Follow-up attempts are completed. No further information is expected.
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| 63 | 2021-04-09 | excessive sleepiness |
Loss 0f appetite. excessive sleeping for 3 days. Light headed upon arising. body aches, coughing up ...
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Loss 0f appetite. excessive sleeping for 3 days. Light headed upon arising. body aches, coughing up thick mucus. condition lasting 9 days after covid19 shoot.
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| 63 | 2021-04-09 | excessive sleepiness |
Received vaccine at 10am CST 04/09/2021. By 6pm, whole-body chills had set in, as well as whole-body...
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Received vaccine at 10am CST 04/09/2021. By 6pm, whole-body chills had set in, as well as whole-body joint pain. Fever was 102. Took 2 Ibuprofen for the aches and 2 aspirin for the fever. Retired 0930pm. On 04/10/2021, awoke at 0730am, feeling fatigued, but chills were reduced from previous evening. Continued with ibuprofen and aspirin. Went back to bed, as still feeling fatigued and chills. Temp 101. By 0200pm, feeling better but not normal, so continued ibuprofen/aspirin regime.
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| 63 | 2021-04-10 | feeling abnormal, confusional state, feeling drunk |
Severe shaking of body, mainly arms and legs on 4/1/2021. Lasted on and off for 2 hours. Feeling ver...
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Severe shaking of body, mainly arms and legs on 4/1/2021. Lasted on and off for 2 hours. Feeling very dizzy, slightly nauseous and my skin was crawling. Felt intoxicated. Tried to stay calm. Had taken Advil pm and went to sleep. Woke up the next morning feeling shaky, difficulty walking. Slight headache on top of head. Blurred vision would come and go. Took 1/2 Prednisone 20 mg (which I take when migraine severe). Felt better early afternoon. Again shaking while sitting down late afternoon 4/2/2021. Feeling weird. Slept through night. Next day only one episode of shaking. During 10 days afterwards still periods of getting dizzy, feeling my heart beat in my ears, at times feeling confused, when typing my left hand sometimes fails to respond.
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| 63 | 2021-04-10 | feeling abnormal |
On Friday, the next day less than 24 hours, I broke out in a rash, hives/whelps, on my arms, torso, ...
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On Friday, the next day less than 24 hours, I broke out in a rash, hives/whelps, on my arms, torso, upper legs, that was itchy and very uncomfortable, I took 2 Benadryl about 5pm, then 2 more about 9pm, went to bed and woke up several times during the night itching, Saturday morning took 2 more Benadryl and it started to fade and was less itchy, I felt achy and my knees hurt, I have arthritis in my knees. Saturday evening the rash/hives came back and today my knees are extra achy. Today, Sunday, still achy and a little of the rash still visible. Wondering if I should get my 2nd shot in a few weeks.
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| 63 | 2021-04-10 | excessive sleepiness |
(This is actually my second ?First? shot because the first one was deemed possibly ineffective due t...
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(This is actually my second ?First? shot because the first one was deemed possibly ineffective due to storage issues.) My right arm was pretty sore starting about mid-afternoon, so sore it hurt to move it. I took tylenol at bedtime and my arm felt better in the morning but I started feeling really achey and tired. I ended up sleeping for another 2 hours, from 11am to 1pm. My body was really sore...shoulders, my right armpit, hips, lower back, knees, thighs. More so than normal. Lasted the full day after the shot. Felt much better on the 3rd day (April 11, 2021)
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| 63 | 2021-04-10 | panic reaction, sleep disorder, depression, anxiety, amnesia, abnormal behaviour |
For the first several days I had loud ringing in my ears and pressure in my chest. Then, I experienc...
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For the first several days I had loud ringing in my ears and pressure in my chest. Then, I experienced a full-blown flare of my encephalitis symptoms: constant nausea, dread/doom/anxiety/panic, memory loss, loss of balance, extreme fatigue, weakness, sleep disturbance, GERD, depersonalization, bizarre ideation.
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| 63 | 2021-04-11 | feeling abnormal |
Pt called to report symptoms post pfizer vaccine #1 which she received on 4/7/21. She began to expe...
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Pt called to report symptoms post pfizer vaccine #1 which she received on 4/7/21. She began to experience symptoms 12 hrs after vaccine administration. She felt faint, "pins and needles" all over her body, and particularly in her lips. She reports feeling "wired" even though she was very tired. She experienced nausea and chest tightness the next moring. Her symptoms were gone by 4pm 4/8/21. She is reporting this as she is worried about vaccine #2, scheduled for 4/29. Allergy consult placed, and pt encouraged to contact her PCP re need for any cardiac work up.
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| 63 | 2021-04-11 | insomnia |
This was my second shot. Just for background, my reaction to the FIRST SHOT was minimal (slight hea...
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This was my second shot. Just for background, my reaction to the FIRST SHOT was minimal (slight headache) until the 2 WEEK mark (after my checkin) when all of a sudden I had **5 canker sores in my mouth (both cheeks/ NOT cold sores) and also a ** buzzing in my ear. I received my second shot on 3/26/21 .. minimal reaction except sore arm - until 2 WEEKS exactly (again.. and after check in). ****Enlarged inguinal lymph node on right side with pain and sleeplessness. Over an inch... maybe the size of a pecan in its shell?? No sign of infection - as far as I can tell - no urinary burning or pain. no extra discharge, etc.. no cuts. also, continued buzzing in ears and sores on tongue and lips - all at the 2 week mark. FYI, the enlarge lymph node, ear buzzing and multiple canker sores are highly unusual for me!!
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| 63 | 2021-04-12 | feeling abnormal |
About 17 minutes after the administration of the vaccine the patient refer that she started to feel ...
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About 17 minutes after the administration of the vaccine the patient refer that she started to feel dizziness, tremors, daze and weakness
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| 63 | 2021-04-12 | insomnia, abnormal dreams, anxiety |
This was my 2nd shot. First was given 3/16/21. No issues with first shot. After 2nd shot - Large ...
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This was my 2nd shot. First was given 3/16/21. No issues with first shot. After 2nd shot - Large canker sore under tongue day after injection. Diarrhea on 4/6 and 4/7. Friday 4/9/21 blood pressure spiked to 180/128. Eventually came down to 150/101. This was determined at a doctors office where I was to have a minor surgical procedure. Had to cancel due to BP so high. 4/7 through today 4/13/21 have felt anxious, difficulty sleeping and weird dreams when I do, hot flashes and itching at night , lethargic, loss of appetite, dizzy, anxiety, general feeling of being unwell. I thought it was important to report these side effects as they are not the usual ones listed for this vaccine. I have heard other people having similar side affects as me.
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| 63 | 2021-04-12 | loss of personal independence in daily activities |
Pt received second dose on 04/02/2021 no adverse effects noted at this time. Pt contacted customer s...
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Pt received second dose on 04/02/2021 no adverse effects noted at this time. Pt contacted customer service on 04/13/2021 in regards to second dose vaccine administration. Pt reported " shortly after, they experienced extreme pain in arm and shoulder making daily activities difficult". Pt contacted PCP and told that they"re "experiencing SIRVA from vaccine being administered too high in arm"
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| 63 | 2021-04-13 | feeling abnormal |
Experienced extreme vertigo with nausea & vomitting, brain fog, headaches, sweats, eye twitching, pr...
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Experienced extreme vertigo with nausea & vomitting, brain fog, headaches, sweats, eye twitching, pressure my head, questionable vision changes
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| 63 | 2021-04-13 | memory impairment |
On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 ...
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On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 strokes. I woke up with a throbbing headache and then had difficultly remembering simple things like using the remote control for TV. My vision was also somewhat blurry. I then went to drive and my focus was off making driving difficult so I then went to the emergency room
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| 63 | 2021-04-14 | confusional state, excessive sleepiness, nightmare |
Trouble Breathing Blood Pressure spiked to 170/110 Lightheaded Confusion Slept from 6pm Friday after...
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Trouble Breathing Blood Pressure spiked to 170/110 Lightheaded Confusion Slept from 6pm Friday after the shot till Monday morning @ 7am. Awake for short period of time 2 or 3 hours intervals Night sweats and bad dreams Left arm never hurt at all Neck pain on left side Pain moved to my back Entire body aches and soreness Trouble seeing clearly Today - Thursday April 15th I am feeling much better this afternoon Blood Pressure back down to 134/78 All other symptoms have subsided
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| 63 | 2021-04-14 | feeling abnormal |
Patient received her second Pfizer vaccine and within 10 minutes of the administration, the patient ...
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Patient received her second Pfizer vaccine and within 10 minutes of the administration, the patient had a rash and was itching. Patient stated she did not feel right. A rapid response was called, Benadryl IM was administered and patient was transported via wheelchair to Urgent Care.
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| 63 | 2021-04-14 | sleep disorder |
Day 1 and 2, extreme fatigue, pain and aches in my hips and buttocks which subsided each day but la...
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Day 1 and 2, extreme fatigue, pain and aches in my hips and buttocks which subsided each day but lasted 4 days until Sunday 4/11/21. Monday at 1 am I was woken up from a deep sleep by a severe twitching on the right side of my face, below my cheek bone pulling the corner of my mouth up. This lasted about 1 minute. Monday I felt a little numb in the area. By Tuesday, the 12th, I felt 90% back to normal regarding each of these side effects.
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| 63 | 2021-04-15 | impaired work ability, impaired work ability |
Headache and discomfort for duration of initial day. Itching and rash on site and on arm/hand where ...
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Headache and discomfort for duration of initial day. Itching and rash on site and on arm/hand where shot was given. Following day(Sunday) experienced more headache and muscle aches and joint pain. fatigue. Some abdominal discomfort and intestinal distress.These symptoms lasted ino Monday. Monday did not work, continued to experience flu-like symptons. felt chills but did not have fever above 99 during any of time. Abdominal discomfort continued through Tuesday
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| 63 | 2021-04-18 | feeling abnormal |
intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up...
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intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.
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| 63 | 2021-04-18 | sleep disorder |
The morning I received vaccine 4/6/21, I had no ill effects. I received the vaccine about 4 and 1/2 ...
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The morning I received vaccine 4/6/21, I had no ill effects. I received the vaccine about 4 and 1/2 weeks after having Covid. The next morning 4/7/21 I had severe aches and pains and a fever of 99-100.5. I stayed in bed all day, the fever ended at 7 pm that evening. That evening I went to bed feeling weak tossed and turned the enter night had very severe aches and pains worse than normal my entire body from my neck to my legs, the aches and pains were unbearable. I took cipro at 5 am that morning 4/8/21 due to a UTI infection with a lot of water no food. I got up with the aches and pains I had and felt very nauseous. I decided to shower and felt faint. I passed out for 30-40 seconds on my bed according to my husband when I came to I had no recollection of fainting, This all happened at around 7am. I ate a few bites of a half of a ham sandwich and had juice which helped to get me to feeling a bit better. My husband took my pressure that was very low my doctor who I spoke to said this may have caused me to faint but that the vaccine may have led to this as well. I was weak from it all but started to feel better and I?m fine now. My next vaccine is April 27, I?m afraid to take it but the doctor advised to take it.
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| 63 | 2021-04-19 | anxiety |
Acute vertigo with vomiting started on April 2 at 12:30 in the afternoon. The vertigo and vomiting c...
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Acute vertigo with vomiting started on April 2 at 12:30 in the afternoon. The vertigo and vomiting continued until zofran was prescribed at which point the nausea stopped when I did not move in the bed. Vertigo was constant for April 12th. On April 8th I saw my PCP. She prescribed continued my zofran prescription and added Xanax and meclazine. On April 13th I had a tachycardia event with 114 bpm for 10 minutes. The vagus maneuver worked on my 3rd attempt and my bpm resumed at 70 bpm. I am still experiencing slight vertigo. My gait is not yet steady and I cannot drive because to turn my head brings on dizziness. I am scheduled for my second vaccine Thursday April 22 at 1:00. Needless to say-I am very anxious about taking it. But my cardiologist, ENT and PCP all recommend that I finish getting vaccinated.
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| 63 | 2021-04-19 | feeling abnormal |
Persistent rash after pfizer vaccine says rash started 1 am Thursday after vaccine Tuesday last week...
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Persistent rash after pfizer vaccine says rash started 1 am Thursday after vaccine Tuesday last week. Rash has been on arms, legs, breasts. No difficulty swallowing, breathing at baseline. Went to urgent care after speaking to physician 4/17 and was given topical steroid and referred to allergist. Called back yesterday b/c sx persisted- Prednisone 50mg started yesterday, by HCP and sx are improving. Pt reports long standing hx of GI issues- chronic constipation which causes N/V. She is having a complete workup with GI for this. Vomited once Thursday night when she was constipated, took laxative as recommended by GI and no sx since then, but does get loose stools from laxative. Rash persists on the right arm inner elbow, left elbow rash improving, improving on the legs. She reports previous brain fog is improving. She has chronic fatigue, unchanged for over a year. She reports loss of tastes x 3 days. Denies other URI sx. chronic back pain, no change. She reports hx of recurrent sx like this following new medications, never with vaccines. She will be f/u w/ allergist for further evaluation.
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| 63 | 2021-04-20 | amnesia |
The day after my first dose I started experiencing memory loss. I went to local urgent care and was ...
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The day after my first dose I started experiencing memory loss. I went to local urgent care and was then transported via ambulance to local hospital. I was admitted to hospital and kept overnight. Diagnosis was Transient Global Amnesia. I remember nothing of my visit to urgent care, the ambulance ride, initial testing at hospital....TGA lasted approximately 4 hours.
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| 63 | 2021-04-20 | feeling abnormal, amnesia |
I experienced memory loss the day after the first dose...was brought to urgent care and then transpo...
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I experienced memory loss the day after the first dose...was brought to urgent care and then transported via ambulance to local hospital I was admitted and released the following day. Diagnosis was Transient Global Amnesia. I have no memory of most of the tests and procedures that were administered at urgent care or the hospital and I am still experiencing headaches and brain fog. I believe the TGA lasted approximately 4 hours.
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| 63 | 2021-04-20 | excessive sleepiness |
Injection site pain, tiredness, headache, muscle pain, chills, fever, injection site swelling, nause...
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Injection site pain, tiredness, headache, muscle pain, chills, fever, injection site swelling, nausea, feeling unwell. Took Tylenol for pain in arm. Drank a lot of fluids and slept most of Thursday 4/15 to Friday 4/16. Saturday 4/17 fever broke still had a dull headache , no nausea wasn't as weak. Felt better as the day went on. Saturday evening 4/ 17 was back to feeling well.
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| 63 | 2021-04-20 | loss of personal independence in daily activities |
Suffered 2 major/large strokes in her occipital lobes and small temporal stroke She is now blind,...
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Suffered 2 major/large strokes in her occipital lobes and small temporal stroke She is now blind, unable to walk, sit, stand, eat by herself, and has speech issues. She is needing full care at this time and unknown what future holds She has been in ICU since 4/17 as we found her unconscious 4/17-she was down by herself tor over 24 hours
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| 63 | 2021-04-22 | insomnia, disturbance in attention |
Day of injection, started feeling like I was light headed and high, could not concentrate. The next ...
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Day of injection, started feeling like I was light headed and high, could not concentrate. The next three days, muscles in back of neck and shoulders tightened, hard to lift arms, tired and headache on left side, coughing and hot flashes started on Friday to Sunday with insomnia and diarrhea, saw doctor on Monday . As of today, headache on left side of temple and muscle soreness
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| 63 | 2021-04-23 | insomnia, disorientation, feeling abnormal |
Immediate pain upon injection. Burning sensation down left arm. Within a few minutes dizziness/disor...
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Immediate pain upon injection. Burning sensation down left arm. Within a few minutes dizziness/disorientation. 3/19/21 at 1 AM wake to joint pain. Any injury, i.e. broken bone, sprain, etc. ever had was now inflamed & painful. Awake for 2 days due to pain. Overall muscle weakness. Attempted to "carry on" except the worst symptom appeared, BRAIN FOG. Could not remember words that started with s, sc, sh, etc. Would lose my car in parking lots. Couldn't finish sentences. Saw primary care physician on 3/26/21. Ordered MRI w/o contrast on 4/14with no acute process or findings to report. Saw masseuse on 3/26/21 & she wanted to know, "Why are you joints hot?" Symptoms began to subside around 4/19/21.
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| 63 | 2021-04-23 | insomnia, panic attack |
Symptoms: Empty Stomach, Heartbeat runs fast, Dizzy and Vertigo, headache, fatigue, sweating, sleepl...
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Symptoms: Empty Stomach, Heartbeat runs fast, Dizzy and Vertigo, headache, fatigue, sweating, sleepless and low blood sugar symptoms. Time Course: It happens when I feel empty stomach, it is around 4 times a day. Signs: Heart palpitations, follows dizzy and vertigo and sweating, I have to drink apple juice or some kind of sweet to relief the symptoms. Doctor Comment: Panic attack or Vasovagal reaction, she prescribed Hydroxyzine HCL 10mg every six hours as needed. I take 1 pill a day before bedtime. As of today, I am still feeling that symptoms around, and that was my first dose of shot. I went to urgent care twice and went thru all testing, and lab test results are Ok. But the symptoms are really bother me. April 29, I will see the allergy doctor if I have any allergy related to the drug
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| 63 | 2021-04-23 | sleep disorder |
face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face w...
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face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; Continued to worsen all day and night. Eyes and lips swelled shut; entire face and neck brilliant red; max amt of itching; neck still red and bumpy; Have been unable to sleep well; This is spontaneous report from a contactable healthcare professional (patient herself). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 04Feb2021 at 15:15 PM (at the age of 63-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included diabetes Type 2, hypothyroid, shingles 10 years ago. Patient had known allergies. Concomitant medications included Synthroid, Rosuvastatin, Metformin, Tresiba and Ozempic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 04Feb2021 at 20:00 by midnight, the patient's face was swelling, bright red, and very itchy. She took one Benadryl. Her face and neck worsened, got into MD in morning. She prescribed Claritin and make appointment with allergist. Patient did both. Events continued to worsen all day and night. Her eyes and lips swelled shut, entire face and neck brilliant red with maximum amount of itching. Patient kept ice on face and neck all night but continued to worsen. She went into hospital Emergency Room at 9:00 AM, received IV Prednisone, Benadryl and one more. Also, prescribed with Famotidine, Prednisone, Benadryl and Tylenol if needed for home. Itching started subsiding, brilliant red remained everywhere, swelling was still significant around eyes and cheeks, neck was still red and bumpy. Patient have been unable to sleep well. She took appointment with allergist 08Feb2021 morning. She wondered if she should take second vaccine and reported that this has been an expensive and emotional nightmare. The outcome of the events was not recovered.
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| 63 | 2021-04-24 | delirium |
some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headach...
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some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-24 | feeling abnormal, mental status changes, thinking abnormal |
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ...
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Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
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| 63 | 2021-04-24 | excessive sleepiness, feeling abnormal, confusional state |
Tested positive for Covid 19; Low grade fever; Head cold; Little cough/lingering cough/cough; Sneezi...
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Tested positive for Covid 19; Low grade fever; Head cold; Little cough/lingering cough/cough; Sneezing; Slight headache; Very lethargic; I had a dull ache; Confusion, kind of foggy; Confusion, kind of foggy; Tiredness; sick; She slept for 15 hours; Could feel it in her teeth; Sinus infection; This is a spontaneous report from a contactable consumer (patient, self-reported). This 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6208 and expiry date was not provided), via an unspecified route of administration, in arm left, on 19Mar2021 at 13:10, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient reported that she got her first dose of the Covid 19 Vaccine on 19Mar2021, and she had side effects starting the night of 20Mar2021. That weekend she had all the side effects. She probably had Covid when she got the shot. She had all of the side effects, and they are the same side effects listed on the pamphlet. Her immune system is heightened, that's how her body reacts to it. Someone at work got Covid, and the patient tested positive for COVID on 31Mar2021 but it could be viral shedding. She was supposed to go for her second dose of the vaccine on Friday (09Apr2021) at 1 PM. She was better at this point, she still has a little cough from 25Mar2021. Her question is can she get the second dose on 09Apr2021. The Board of Health said she should go. She mentioned that she thinks she lost a half an inch as she was 5'5", she was shrinking. Patient had tiredness on 19Mar2021. Reported that her symptoms pretty much were tiredness. Her arms felt like they were 20 pounds, she was very lethargic on 20Mar2021. She had a slight headache and confusion, she was kind of foggy from 20Mar2021. A couple days after that, midweek she started getting a head cold and cough on 25Mar2021. She doesn't know if it was from the flu, a side effect, or Covid. She went to Urgent Care for her head cold on 27Mar2021 and they gave her a Z Pack and a medicine for cough. She still has a lingering cough. The Z Pack helped with the sinus infection. She tested positive after that. She is quarantining from (Name) and waiting to get her second shot. Stated that there was also a head cold going around her office, some people with Covid and some not. She doesn't know if this is a combo effect for her. She got the shot at 13:10 and went back to work, then she came home and went to sleep. She was tired the whole weekend. She didn't feel herself. Her head felt like a dull ache from 20Mar2021, maybe just foggy, she was not thinking clearly and was not herself. Really on Monday she went to work and still had side effects thinking it was from the shot because she was fine until she got it, but some people said she had Covid when she got the shot. It was reported that she had a negative Covid test that Sunday before. She gets a test every weekend so she can see her granddaughter. She has probably had 50 tests. She was very prone to negative tests, then all of a sudden after the vaccine everything was different. She doesn't know if it is Covid or a reaction to the vaccine. She had a positive rapid test on 31Mar2021, and the PCR on 01Apr2021 came back positive. They said it was viral shedding. She was starting to feel better. She was more tired than she usually is. Usually she only needs 3 or 4 hours of sleep. She works from home. She slept for 15 hours when she got off at 17:00, and she slept in. Now she sleeps a little more, probably what normal people sleep, so she is not as tired as she was. She is not back to 100 percent herself since she usually only needs 3 or 4 hours of sleep. She is tired at the end of the day. She can function and do her routine. She worked yesterday from 09:00 to 20:00. She came home and fell asleep. It is harder working from home with phone calls and emails, everything takes longer. She got it done and she can think straight. Most of her symptoms have subsided except for the cough, and even that is just here and there. It is not like she can't breathe or it hurts. Her headache is not bad, just a dullness that's gone. It was maybe 3 or 4 days through until Tuesday. Tuesday and Wednesday she was better and Thursday she got a head cold. She read that she can't get Covid from the vaccine, but it said all of these side effects could have come from the vaccine so she has no idea. The headache was like a fuzziness, a dull ache. She had sneezing on Thursday (25Mar2021) when she got the cold, then Friday 27Mar2021, she had a low grade fever. She went to Urgent Care on Saturday. At Urgent Care they didn't test her for Covid, but she had a 99.1 fever there and he gave her a Z Pack. They gave her some pills for the cough. They said the cough was from post nasal drip. She didn't know if it was or wasn't. Her lungs were clear, so they said the cough was from that. The Z Pack was from Saturday to Wednesday, it was a 5 day pill thing. She took her last pill Wednesday when she was taking the Covid test. She just has the cough now, she doesn't know if it was that or something else. The head cold went away Thursday or Friday. She doesn't know what the cough is from. She thought it was part of the cold and it started on Thursday. She didn't have a cough as a side effect, it started with the cold. She is nasally still, she can hear it. She had the fever maybe for a couple days, she could have had it and didn't know. She has recovered completely from it. She hadn't had Covid until she got the shot. It's been 3 weeks since she's been sick. She hasn't had any test other than the Covid test. She could feel it in her teeth. Outcome of the event Head cold was recovered on an unknown date in Mar2021, Low grade fever and Sleep excessive recovered in 2021, event Tiredness was recovering; the events Confusion, kind of foggy and slight headache were recovered on 23Mar2021: Event cough was not recovered; for remaining events outcome was unknown.
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| 63 | 2021-04-24 | excessive sleepiness |
Immediately after the vaccines, I experienced severe flu-like symptoms. After the second vaccine, I ...
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Immediately after the vaccines, I experienced severe flu-like symptoms. After the second vaccine, I also experienced a visual issue. Everything in my visual for appeared to be dusted in light gold on the second day after the second vaccine. Two months after the vaccine, I started to experience an extreme exhaustion. It has currently been 5 weeks now. Is this a side effect of the vaccine?
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| 63 | 2021-04-24 | insomnia, loss of personal independence in daily activities |
could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right fo...
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could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right foot and traveled up to knee/It came on and off/the pain was unbearable/The muscle pain at first was on the right leg only and last night it was both legs.; Right arm soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 63 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534) via intramuscular, administered in arm right on 25Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included high cholesterol. She is pretty healthy. No vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medications included pravastatin (40 mg tablet) for high cholesterol taking for 2 years and stopped since Friday (unspecified date); Vitamin D. After having the first injection at a hospital, patient did not feel anything, just a little right arm soreness (25Mar2021 14:30). But exactly a week after, on Thursday (30Mar2021), she started to feel muscle pain in her right leg, from right foot and traveled up to knee. It came on and off. She did not take any medication. But Friday (02Apr2021) it got worse, she took only one paracetamol (TYLENOL Arthritis PAIN 650 mg, Count size 24 caplet, Lot: SLA055, Expiration: Jul2023) and felt okay. On Saturday (03Apr2021) happened again, she also took one in the morning and at night. On Sunday (04Apr2021), she felt again in morning took 1 paracetamol and at night she took another one, the pain was unbearable. Next Monday (05Apr2021), she almost called 911 at 7pm but she didn't do it, her neighbor is a nurse for 46 years and she told her to take two paracetamol. Last night (05Apr2021), she took two. She could not sit down and sleep before (Apr2021). She was able to sleep. This morning she felt it again (06Apr2021), her neighbor told her to take 2 for 3 times or every 6 hours. She took 2 this morning. She is scared. She called her doctor. She was going to call 911 last night because the pain was bad and she was scared. The muscle pain at first was on the right leg only and last night (05Apr2021), it was both legs. She needs the right medicine. The doctor said she should call Pfizer and discuss. She wondered if it is okay to take second dose and what the right medication is to take to help with the pain. Patient did not visit emergency room. The patient assessed the report as serious. Outcome of muscle pain in legs was not recovered, outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-04-24 | insomnia |
Mild flu-like symptoms; beginning with sleeplessness; headache; fatigue; waves of mild nausea; muscl...
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Mild flu-like symptoms; beginning with sleeplessness; headache; fatigue; waves of mild nausea; muscle/joint aches; muscle/joint aches; waves of muscle spasm in right groin area; This is a spontaneous report from a contactable Other Health Professional reported for herself that a 63-year-old Female (no pregnant) patient received 2nd dose of Pfizer COVID-19 vaccine BNT162B2 (lot/batch number: EN6201) at Left arm on 02Mar2021 at single dose for covid-19 immunization. Medical history was Fibromyalgia, Arthritis, Lumbar disc bulge. Allergies to medications, food, or other products: PCN, codeine, ephedra, gluten. Concomitant drug included Progesterone, estradiol (ESTROGEN), minerals nos/quercetin/thioctic acid/vitamins nos (EMERGEN-C), ergocalciferol (VIT D), zinc. No other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine was 1st dose of BNT162B2 on 09Feb2021 (lot/batch number: EL9269) at Left arm for covid-19 immunization. Patient experienced Mild flu-like symptoms: beginning with sleeplessness, headache, fatigue, waves of mild nausea, muscle/joint aches and waves of muscle spasm in right groin area. All lasted less than 24 hours from 03Mar2021 02:00 am with outcome was Recovered. No treatment. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-04-26 | insomnia |
Side effects that started with pain in arm where injected, then achiness in whole body, chills was ...
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Side effects that started with pain in arm where injected, then achiness in whole body, chills was sleepless that night. The next morning (4/25) felt very tired, no energy, overall felt sick with flu-like symptoms, and stomach ache. Fever up to 101.6F.
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| 63 | 2021-04-26 | loss of personal independence in daily activities |
When I got out of bed the morning of 4/1/2021 at 8 am, I went to turn off my humidifier in my bedroo...
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When I got out of bed the morning of 4/1/2021 at 8 am, I went to turn off my humidifier in my bedroom. In turning off the humidifier, I leaned slightly to the left, felt the vertigo, and fell down on the bedroom floor. I could not do anything to keep myself from falling. Though able to stand up and walk a few minutes later, the vertigo persisted for several days. I did not have another falling event; however, since then I have restricted my head movements to avoid re-triggering the vertigo. To this day, at times I feel at risk of re-triggering the vertigo when I move my head too quickly, though I have resumed my usual daily activities and exercise routine.
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| 63 | 2021-04-30 | confusional state, disorientation |
disoriented; confusion; weak/lack energy; facial and tongue numbness; facial and tongue numbness; di...
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disoriented; confusion; weak/lack energy; facial and tongue numbness; facial and tongue numbness; dizzy and light headed; This is a spontaneous report from a contactable other HCP. A 63-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 02Apr2021 11:00 (Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included hypothyroid (long standing with no new meds), allergies to nkda. Concomitant medication included levothyroxine sodium (SYNTHYROID). On 02Apr2021 11:15 am, the patient felt disoriented, confusion, weak, facial and tongue numbness, dizzy and light headed, lack energy lasted 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of the events was recovered on 12Apr2021. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-04-30 | nightmare, restlessness, delirium |
stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has...
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stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.
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| 63 | 2021-04-30 | thinking abnormal |
Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anyth...
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Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation. On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder". No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-05-04 | loss of personal independence in daily activities, feeling abnormal |
Later that night, on 1/27/21, I felt sick, Nausea, muscle soreness. Next day 1/28/21 went to work wi...
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Later that night, on 1/27/21, I felt sick, Nausea, muscle soreness. Next day 1/28/21 went to work with headache, couldn't lift my arm up very swollen. Felt sick got worse felt very hot. Temperature of 104, got sent home from work. Took Acetaminophen and 2 cold tablets fever went down to 101.9. Took cough syrup. Went to sleep. got up next norming arm still very swollen, went to work got sent home no fever but still felt bad, achy muscles and arm still swollen. Stayed home in bed whole weekend. Got headache every day including Monday morning when got up to go to work. Headach on Tuesday also. Felt better on Wednesday. Woke up with headache on Thursday. Woke up with a headache on Friday.
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| 63 | 2021-05-04 | nervousness |
she actually feels like she has covid; she actually feels like she has covid; felt like her head was...
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she actually feels like she has covid; she actually feels like she has covid; felt like her head was in a tunnel/surround sound in her head; she was scared to death; ringing in her ears; diarrhea; nausea; ear aches that make it feel like her hearing is off; the vaccine may have poked her in the bone; temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit; felt like I wished I were dead; sick; tired; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318; Expiration Date: 2021), via an unspecified route of administration, on 09Apr2021 at 14:30 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EP69556121) on 18Mar2021 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. There were no concomitant medications. The reporter state that exactly seven (7) days after her second dose, she "felt like I wished I were dead." She reports having diarrhea and nausea that she is still struggling with, and also reports ear aches that make it feel like her hearing is off, describing it as an echo "like I'm in a tunnel or buried in the sand." She reports that this "head thing" was so severe in the beginning and reports that it is still ongoing. She states she couldn't even stand to hear the television and reports that it felt like there was a "surround sound" in her head. She also reports that she just wanted to lay in bed one afternoon and when she woke up the next morning, she was still tired. She reports now that she is progressively feeling "some better" and thinks in 3 days that it will be gone, but she also believes that she may have COVID-19 now and feels like the 2nd Pfizer Vaccine actually bred the disease in her for some reason and she wished she was dead for three days. She also stated that she has spoken with her HCP about this who suggested she visit an urgent care; however, the caller states she cannot drive and has no means of transportation to this appointment. She continued to say that the symptoms were horrible and she is still going through it; states last night she was scared to death and she does not drive or she would have taken herself to the emergency room. She stated that she still had the ear ache, it is not so "echoey" but she still hears some of the ringing in her ears. The other thing concerning happened yesterday - she has also been monitoring her temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit and she has been trying to get ahold of someone to report this. States last night was the worst night with diarrhea and she was up and down all night long. The patient also mentioned that her second dose of the Pfizer Vaccine was in her right arm and the woman who gave her the vaccine may have poked her in the bone and caused her to jump. The patient experienced that she actually feels like she has COVID on an unspecified date with outcome of unknown, felt like "I wished I were dead" in Apr2021 with outcome of unknown, the vaccine may have poked her in the bone on 09Apr2021 with outcome of unknown, diarrhea on 16Apr2021 with outcome of not recovered, ear aches that make it feel like her hearing is off on 16Apr2021 with outcome of not recovered, tired in Apr2021 with outcome of recovering, felt like her head was in a tunnel/surround sound in her head on 16Apr2021 with outcome of recovering, nausea on 16Apr2021 with outcome of not recovered, she was scared to death on 16Apr2021 with outcome of not recovered, ringing in her ears on 16Apr2021 with outcome of unknown , temperature and it has been pretty normal for the most part and went up to 99.9 degrees fahrenheit in Apr2021 with outcome of unknown and sick in Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.9 degrees Fahrenheit on Apr2021.
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| 63 | 2021-05-11 | impaired work ability |
Overwhelming fatigue and achiness for 48 hours. Ibuprofen eased achiness but fatigue was so severe,...
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Overwhelming fatigue and achiness for 48 hours. Ibuprofen eased achiness but fatigue was so severe, I missed a day of work.
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| 63 | 2021-05-17 | confusional state, loss of personal independence in daily activities, feeling abnormal, insomnia |
very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficul...
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very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy
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| 63 | 2021-05-18 | feeling abnormal |
meaning fever and chills; meaning fever and chills; felt generally terrible; Diarrhea; cough/dry cou...
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meaning fever and chills; meaning fever and chills; felt generally terrible; Diarrhea; cough/dry cough; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration on 26Jan2021 (at an age of 63-years-old) as single dose for covid-19 immunisation. Medical history included covid-19 from 23Dec2020 (23Dec2020 she tested positive for Covid-19). There were no concomitant medications. The patient previously took bnt162b2 (batch/lot number: EK9231) and experienced chills, fever, arm hurt real bad. On an unspecified date the patient experienced meaning fever and chills, felt generally terrible. On 28Jan2021, the patient experienced cough/dry cough. Caller reported that she is a healthcare worker and just retired. She clarified that she is a Dietician. She called yesterday and reported the fact that she had COVID in Dec2020, after having COVID, she had both doses of the Pfizer Vaccine. Second dose this week. She had Adverse reactions to both doses, meaning fever and chills. Yesterday, she started with a cough. She wants to make sure that this is all reported correctly. When she talked with someone yesterday and talked with someone who's accent she could not understand. Not hearing that any coughs were supposed to be a potential side effect of the vaccine. Patient had the first vaccine on 05Jan2021, Lot EK9231, and the 2nd dose on 26Jan2021, Lot EL3248. She had it at the (State name). Yesterday, she had 1 episode of Diarrhea and this morning another episode of Diarrhea. The cough started yesterday and that is biggest concern. She has not been able to see where it was a noted side effect. She spoke to nurse in Pfizer Drug Safety yesterday and then he put her through to next department and that is where she wanted to find more about if there has been any research or if there is in fact an association with the cough. She is now concerned because she again started to develop a dry cough today and wanted to know if this is something she should be worried about since she previously had Covid last Dec2020. "How long will it last?". The patient did not receive any treatment for the events. The clinical outcome of the meaning fever and chills (fever) was recovered on an unspecified date in 2021. Clinical outcome for cough/dry cough, meaning fever and chills (chills), felt generally terrible, diarrhea were unknown. Follow-up attempts are completed. No further information is expected.
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| 63 | 2021-05-18 | sleep disorder |
Woke up in the middle of the night and couldn't breathe. Couldn't walk and talk at the same time for...
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Woke up in the middle of the night and couldn't breathe. Couldn't walk and talk at the same time for 3 days. Had no energy because it was too hard to breathe. Was put in the hospital for 3 days, checking on lungs and heart. Had chest X-rays etc. Could not come up with definite reason, but my condition did not improve. I was put on 2 liter of oxygen (which I was never on prior to shot), and told to see doctor in 7 days.
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| 63 | 2021-05-19 | loss of personal independence in daily activities |
Dizzy; Headache/ sick headache; I have been in bed ever since/I can't turn my head or anything; it g...
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Dizzy; Headache/ sick headache; I have been in bed ever since/I can't turn my head or anything; it got worse today; Sick; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 27Jan2021 (age at vaccination was 63 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for anxiety. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The consumer stated that she had been sick since yesterday. She was at work and got dizzy and had a headache. She took like for the headache, she had like a sick headache at night and she took Tylenol (Lot no: E2392V, Expiration date: 20/22) but it seemed like it got worse today. She had a second shot of the virus shot and she had been in bed ever since. She felt very dizzy. She couldn't turn her head or anything, so she went to urgent care and they told her to call them right away that they thought that might be it was an allergic reaction. (As consumer was sure, hence allergic reaction not captured as event). The consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the website link as (Website provided). The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
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| 63 | 2021-05-24 | sleep disorder |
5-4-21 about 6 hours after shot, I had an extremely sore left arm and tenderness under the left arm ...
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5-4-21 about 6 hours after shot, I had an extremely sore left arm and tenderness under the left arm pit. Beginning about 7 hours after shot, I had chills, fever of 100.2, migraine headache and lower back pain. Did not sleep at all through the night. By morning on 5-5-21, all symptoms still present plus feeling dizzy, light-headed and nausea. Stayed in bed all day. By 6 pm on 5-5-21 (27 hours after shot) I had a fast heart rate and heart palpitations. By 8 pm, I had a tightness and pain in my chest. Difficulty breathing, although that may have been my trying to alleviate some of the pain.
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| 63 | 2021-05-25 | feeling abnormal, memory impairment |
hypoglycemic shock; positive for covid 19; mobility issues; gets out of breath easily; weak; couldn'...
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hypoglycemic shock; positive for covid 19; mobility issues; gets out of breath easily; weak; couldn't remember anything which wasn't normal; WBC was elevated; headaches; went sky high into the 500s and they couldn't control it in the hospital; viral pneumonia; renal failure; Her blood sugar was 28; Covid fog; was not eating or drinking; throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (patient daughter) via Pfizer. A 63-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported and expiry date unknown) via an unspecified route of administration on 25Mar2021 (at the age of 63-year-old) as 1st DOSE, SINGLE for covid-19 immunization. Patient took vaccine as she wanted to fly on an airplane and not worry as heavily. Medical history included ongoing diabetes mellitus, patient had diabetes for at least 5 years, ongoing high blood pressure from an unknown date, reporter think patient high blood pressure was more with her weight because patient was obese. Patient was immunocompromised with her diabetes. Patient had no relevant family medical history. Concomitant medication included ongoing metformin (METFORMIN) taken for diabetes mellitus. Patient has been on it for years. Reporter believed she was on the max dose that she thinks was 2000mg, but could be wrong. Patient was not eating or drinking from 03Apr2021 and did throw up. On 06Apr2021 patient was tested positive for Covid and experienced hypoglycemic shock at 11:00, renal failure and Covid fog. Reportedly, patient also experienced viral pneumonia, mobility issues, gets out of breath easily, weak, her blood sugar was 28, covid fog, couldn't remember anything which wasn't normal, wbc was elevated and headache. The patient was hospitalized for hypoglycemic shock and COVID-19 from 06Apr2021 to 17Apr2021 (11 days), then discharged and was told by her HCP to wait 8-12 weeks before getting second dose of Pfizer covid vaccine. Patient scheduled to receive second vaccine dose 15May2021. Reporter was told that it was a max of 42 days that patient can get the second dose of the vaccine, but that has obviously since passed. They want patient to come in and get a second first shot. When patient was admitted, the doctor thought patient had viral pneumonia already for at least a week, so it would have started about when she got the shot. Patient was better, she was not on oxygen anymore, but she still gets out of breath easily. Patients mobility issues started when she came down with symptoms. Patient had renal failure and was weak. Patient was not eating or drinking. Patient was diabetic and she had hypoglycemic shock which was what put her in the hospital. Reporter thought it was probably a cold or flu or something and Easter happened where she was not hungry and did throw up. Reporter thought it was something she ate that was bad. When she had the hypoglycemic shock reporter could not wake her and patient was in some kind of unresponsive state from 11:00 to about 15:45. Patient blood sugar was 28 when the paramedics arrived. They were able to get her responsive and transferred her to the hospital. They ended up putting her on a dextrose drip because they could not keep her blood sugar up. They put her on steroids and the number went sky high into the 500s and they could not control it in the hospital. There was a lot of stuff that happened. Reporter did not believe that patient has any lasting effects from the hypoglycemic shock. Patient sugar was back to normal and she was on her normal medications. Patient was off insulin which they gave her in the hospital, so that part was okay. Patient was dealing with Covid fog also. Reporter does not know if it has to do with blood sugar or how the virus attacks the body. Patient had multiple MRIs because they were worried, she had a stroke, and she said she could not remember anything which was not normal. Patient not eating and drinking started right before Easter and was much better. Reporter believed that at about 14Apr2021 or so patient started to eat better and have more of an appetite for food. Patient has recovered completely. The reporter did not notice the Covid fog until her mother was in the hospital on 06Apr2021. She does not remember her first week in the hospital, and then even when she was discharged on 17Apr2021 that whole next week she was still very foggy. The reporter would say she was better now. patient talks normally and was back to swearing which is perfectly her. Patient has recovered completely at this point. Patient mobility was better. Patient was not using the walker in the house today, and her balance was better. It was probably due to some of the side effects of the medicines they added like a beta blocker and other things to make sure she was okay. Regarding kidney failure started, reporter stated on 06Apr2021 patient creatinine was 3.99. Patient also had a high D dimer and were worried about her clotting and throwing a PE or something. That was mostly in the first few days around the 6Apr2021, 7Apr2021, 8Apr2021, 9 Apr2021, 10Apr2021 when they were not sure what was going to happen. The following week patient was still at 5 to 6 liters of oxygen, but by Friday night 16Apr2021 she was down to 1 liter of oxygen. Patient did not come home on oxygen. Reporter believed patient kidneys have recovered, but she did not know. The patient underwent lab tests and procedures which included blood creatinine: 1.47 on an unknown date, 0.97 on Sep2020, reporter does not know if it returned to 0.97, but the last number she knows of was 1.47, 3.99 on 06Apr2021, blood creatinine: 1.47 on 17Apr2021. Patient had normal bloodwork in Sep2020 and her creatinine was 0.97. Reporter did not know if it returned to 0.97, but the last number she knows of was 1.47. That would have been when patient was discharged from the hospital. Blood glucose: 500s on an unknown date in Apr2021, blood glucose: 28 on 06Apr2021. On 06Apr2021 patient was tested positive for Covid. On an unknown date patient got CT, high d dimer, CBC, MRI, metabolic function test, white blood cell count, X-ray and Chem 28. Reportedly, bloodwork were done daily in the hospital, and patient has had bloodwork once since she was discharged. WBC was elevated so they did a blood culture to make sure patient did not have an infection. The culture was negative. There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccination within 4 weeks. There were predisposing factors diabetes and immunosuppression. Patient started Tylenol pill on 06Apr2021 after vaccination at an unknown dose. They gave it to her continuously because she had bad headaches. They started her on antivirals and took her off of Remdesivir because of her kidneys. They put her on a different antiviral that the reporter did not remember the name of and a biologic. Home health just discharged patient, and she was still dealing with viral pneumonia and mobility issues. Patient was still on different medicines and she normally was not. The report is related to study or programme. The outcome of the event hypoglycemic shock was recovered on 06Apr2021 and was not eating or drinking was recovered on 14Apr2021, viral pneumonia, mobility issues, was recovering, renal failure, positive for covid 19, gets out of breath easily, weak, her blood sugar was 28, went sky high into the 500s and they couldn't control it in the hospital, covid fog, couldn't remember anything which wasn't normal, wbc was elevated, throw up and headaches was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained
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| 63 | 2021-05-25 | insomnia |
/the swelling of her knees had diminished greatly; She was quite swollen; She could feel it a little...
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/the swelling of her knees had diminished greatly; She was quite swollen; She could feel it a little bit in her shins and ankles, however that pain was not acute, she just felt discomfort.; Sore/ she woke up in agony.; She was up all night Friday night and didn't get any sleep at all; Acute bilateral knee pain/ She could feel it a little bit in her shins and ankles, however that pain was not acute, she just felt discomfort.; She began to feel discomfort in her knees; This is a spontaneous report received from contactable consumer, the patient. A 63-year-old adult female received the first dose of intramuscular BNT162b2 (solution for injection; Lot EW0175 and expiry information not provided) as a single dose in the right arm on 06May2021 at 11:40 (at 63-years-old) for COVID-19 immunization. Relevant medical history included Stage IV cancer survivor, mastectomy with removal of lymph nodes (Feb2020-Feb2020), radiation treatment Apr2020-May2020, infusions (ended in 2020), Breast reconstruction with first Tram flap breast reconstruction 05Apr2021 and Full-blown TRAM flap with muscle and fat from abdomen added to breast 13Apr2021, and pain. Concomitant medications included trastuzumab (HERCEPTIN) from unspecified date for unspecified indication; pertuzumab (PERJETA) from unspecified date for unspecified indication; and hydrocodone bitartrate, paracetamol (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) from 20Apr2021 and from 21Apr2021 for pain. The patient previously received prophylaxis with the flu shot, and the tetanus vaccine with which she experienced sore. The patient reported that she received her first dose of the COVID-19 vaccine on Thursday, 06May2021. The next day, 07 May 2021, she woke up in agony with her knees, the pain was acute, she could hardly bare weight. She confirmed the pain was in her knees, but at times she could also feel it a little bit in her shins and ankles, She did try and treat the pain on Friday during the day, maybe about noon on Friday, she took some over-the-counter ibuprofen 200mg. The patient reported that she does not have pain usually, though was shocked when she took two ibuprofen 200mg tablets and the ibuprofen did not even touch the pain, it had no effect whatsoever. The patient re-iterated that she was administered the first dose of the COVID-19 vaccine on 06May2021 at approximately 11:40AM. Then, the nurse came by, spoke to her, and released her to leave at 11:50-11:55AM. At around 8PM that evening, she began to feel discomfort in her knees. She did not think much of it just through reading info about side effects including achiness and so forth. She went to bed and she slept through the night, which she does not always do. The next day, on 07May2021, she woke up in agony. The patient mentioned that prior to the vaccine, she had been through so many surgeries, so she has a high pain tolerance. The patient explained that she does not even take the pain medication they send home with her. But, with her knees, the pain was acute, she could hardly bare weight. She confirmed the pain was in her knees, but at times she could feel it a little bit in her shins and ankles too, however that pain was not acute, she just felt discomfort. The patient stated that she was up all-night Friday and experienced the pain all day Friday. She told herself to just deal with it and that the pain would get better since she read side effects would dissipate in a couple of days. However, the pain did not, and she was up all-night Friday night and did not get any sleep at all. Saturday morning, on 08May2021, she went to the emergency room (ER). She was seen by an ER physician who immediately put her on IV morphine and steroids and after that, maybe thirty minutes, the pain started easing. She later clarifies she was put on IV dexamethasone and then morphine and ondansetron, stating "maybe that was to wake me up". Caller confirms she has no NDC, Lot number and expiry date for these medications. She confirms she was not admitted into the hospital, she was only there for a couple of hours and then released home with a five-day pack of prednisone. The ER doctor mentioned his colleagues have seen something similar but usually with the second dose. caller explains when the ER doctor examined her, he could see she was quite swollen. She confirms the ER doctor diagnosed her with "acute bilateral knee pain, adverse effects of the COVID-19 vaccine". She came home from the ER and did get some rest. It was to the point now, yesterday she walked around the house and she was not in acute pain at all. She could tell the swelling of her knees had diminished greatly. However, there is still some movement that was uncomfortable, but it was not acute; She confirmed the pain has improved. The patient reported that she did have blood work done in the ER on 08May2021 including C-reactive protein, complete blood count (CBC) with platelet differential, and a comprehensive metabolic panel though results were unknown. The outcome of the events quite swollen/swelling of her knees, sore/ she woke up in agony was recovered on an unspecified date in May2021. The outcome of the events knee pain, discomfort in her knees, feel it a little bit in her shins and ankles, felt discomfort, was recovering. The outcome of the event did not get any sleep at all was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 63 | 2021-05-26 | feeling abnormal |
Brain fog... It continued for 3 days and I could not drive. However, it continues now to a lesser de...
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Brain fog... It continued for 3 days and I could not drive. However, it continues now to a lesser degree with light headedness and loss of balance
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| 63 | 2021-05-27 | disturbance in attention |
In about three days from the first injection I had loud tinnitus 24/7 in both ears. Could not find a...
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In about three days from the first injection I had loud tinnitus 24/7 in both ears. Could not find anything online about it. Considered not getting second injection but one family member had died from the virus. Saw a dioctor for sinus issues and worse tinnitus. He said he had heard others complain about it after the shot. No known treatment. It was getting more difficult to concentrate and focus. Also I had to ask my daughter to repeat some words when we were in the same room. Went to an audiologist for testing. Qualified for hearing aids. Healthcare provider said patients were complaining of worse tinnitus after shot. Previously I had occasional low noise tinnitus, off and on for more than ten years from Betaseron injections years ago. I reported to Pfizer directly about 24/7loud tinnitus. Saw my primary doctor to report it and see if he had heard of any treatments. About May 25thmy right ear had a sudden sharp, piercing sound for a few seconds. A day later it seems the tinnitus is now only in the left ear, or the right ear is much more mellow in tone compared to the left ear. Filled out Vsafe report to the CDC.
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| 63 | 2021-05-31 | insomnia |
She felt a burning sensation whenever the covid vaccine went in; muscle pain all over, her muscles f...
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She felt a burning sensation whenever the covid vaccine went in; muscle pain all over, her muscles felt achy; Tiredness; could not eat; pressure in her ear is from swelling; pressure in her ear is from swelling; throat tightness; could not sleep that night; muscle tightness started in the shoulder/shoulder muscle got tight/tightness went to the back of her neck, then to the front of her neck; hurting so bad; Under her chin, on both sides, there are swollen lumps; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 13:00 (Batch/Lot Number: ER8734; NDC & Expiry date: unknown) (at the age of 63 years old) as 1st dose, single for COVID-19 immunization. Patient took Pfizer COVID vaccine because of her job. She works with the public at a public library. History of all previous immunization with the Pfizer vaccine and additional vaccines administered on same date of the Pfizer suspect were reported as none. Medical history included acid reflux for years, colitis, bad sinus issues for several years and COVID-19 diagnosed on 04Jan2021. Part of her sinus issues, is that her sinuses block up and stuff drips down the back of her throat. Whenever she had COVID in Jan2021, the main thing that bothered her was a terrible sore throat. Whenever she had COVID, she went to an urgent care and the doctor told her that her throat was swollen bad. She kept spitting phlegm out in the toilet, and the doctor told her if it got any worse, she may need to go to the hospital, if her throat is starting to swell closed. The urgent care doctor prescribed her a steroid, and she took that for a week. She has a bad right shoulder; it aches all of the time. She does not like going to the doctor, so she has not had it checked out. She has frozen shoulder in both of her shoulders. She clarified that she had shoulder issues before receiving the first dose of the COVID vaccine. She constantly has neck pain. It is normal for her to have aches in the back of her neck. The pain from her shoulders goes into her neck. Patient reported that there was this thing that runs in her family. She has never been tested for it. It is a disease. Her mom and dad do not think that she has it. She thinks that is called Marie Toothe disease. Concomitant medications included fluticasone propionate (FLONASE) for bad sinus issues, famotidine for 2 years for acid reflux, and has been taking mesalazine (LIALDA) for years for colitis. She takes Flonase pretty much daily in the summer. She stopped taking during the winter. She started taking it again a couple of months ago. She started back taking it whenever things started blooming. Patient reported that she got hives from a flu shot. Flu shot name, NDC, lot number and expiration date were unknown. Hives after a flu shot happened five years ago, she has not gotten a flu shot since. On an unspecified date, the patient called to report reactions. She was concerned about getting her second dose of the COVID vaccine. Patient's weight was between 110 and 120 pounds. She was diagnosed with COVID on 04Jan2021. Because of COVID, she lost weight, she got down to 110 pounds. Now she is putting weight back on and getting back to her regular size of 120 pounds. She lost a bunch of weight whenever she was sick with COVID. She has been trying to call the CDC but has not been able to get through to speak to anyone. She received the first dose of the COVID vaccine in her left arm, because her left arm is normally better. She received the first dose of the COVID vaccine at 1:00PM. They made her sit around and wait for 30 minutes because she has had flu shot reactions before. She waited the 30 minutes and felt okay. Then she noticed at dinner time, about four or five hours after the first dose of the COVID vaccine that she was feeling muscle pain all over, her muscles felt achy. After she got the first dose of the COVID vaccine, she felt like COVID was coming back into throat. At supper time, she could not eat because of throat tightness. She had to eat soup and could not take one of her big pills: Began probably about four to five hours after receiving the first dose of the COVID vaccine. Her throat has been doing this weird thing where it feels better, and then feels tight again. It is back and forth. Right now, it is better. This Saturday, she was supposed to get her second dose of the COVID vaccine. She is worried that her throat will swell up worse. She is asking if she should get the second dose of the COVID vaccine. About one week before receiving the first dose of the COVID vaccine, her throat was sore and bothering her. She went to urgent care on 22Mar2021. She had COVID in Jan2021, her throat has gone back and forth like this. At urgent care, they did a COVID test on her and it was negative. They also did strep test on her and it was negative. The doctor looked at her throat and said he did not see anything. The doctor did not really want to look in her throat. The doctor was worried she may have COVID, so he only took a quick look. She felt like muscle tightness started in the shoulder when she received the first dose of the COVID vaccine. Her shoulder muscle got tight, then the tightness went to the back of her neck, then to the front of her neck. She also had pressure in her ear on that same side; she clarified that pressure was behind her ear. She thinks the pressure in her ear was from swelling. Shoulder tightness, back of neck tightness, front of neck tightness, and pressure behind her ear all happened at the same time. She was hurting so bad. The tightness and pressure come and goes. She is starting to wonder if wearing a mask is causing this. She wears two cloth masks at work. She does not like wearing medical grade face masks because she feels like she cannot breathe. After work, she will come home, and her throat will be a little sore. She was asking if there are lymph nodes in her throat. Under her chin, on both sides, there are swollen lumps. The left side was worse. She put ice on it, and it felt better. Began on 27Mar2021, she could not sleep that night which was weird because it comes and goes. Whenever it comes and goes, it was probably not as bad as the day that she received the first dose of the COVID vaccine. It still hurts. She was asking if this is an immune inflammatory response. She was supposed to get her second dose of the COVID vaccine this Saturday. She is freaking out about it. Everyone has told her that the second dose of the COVID vaccine is worse than the first dose. She was asking if they can give her the second dose of the COVID vaccine in her thigh instead. She is worried that if she gets the second dose of the COVID vaccine in her thigh, that she will not be able to walk after. The adverse events did not require a visit to the Emergency Room/Physician Office. She is thinking about going to see a doctor. The night that she received the first dose of the COVID vaccine, she thought to herself that if she got any worse, she would go to the emergency room. She was close to going to the emergency room. There were no prior vaccinations (within 4 weeks). The outcome of the event burning sensation was recovered, muscle pain was recovering, tiredness was not recovered, while for the other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-06-01 | crying, anxiety |
a low grade fever; worried; emotional basket case; she experienced emotional side effects stating sh...
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a low grade fever; worried; emotional basket case; she experienced emotional side effects stating she felt paranoid and was crying.; she experienced emotional side effects stating she felt paranoid and was crying.; Body temperature running 2 degrees high; Headache; Arm site injection pain; Broke out into a couple of drenching sweats; This is a spontaneous report from a contactable consumer. A contactable 63-year-old female consumer(patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0186) via an unspecified route of administration on 21May2021 on left arm as a single dose for COVID-19 immunization. The patient's medical history included Asperger's syndrome (From: Unspecified To: Ongoing), she was diagnosed with Asperger's at age 57 and has had this type of reaction with other drugs and foods in the past. She says she has taken antidepressants in the past which caused this type of reaction which included having suicidal thoughts. She had history of high blood pressure (From: Unspecified To: Ongoing) since she was 32 years old. The patient reported that she developed high blood pressure during pregnancy with her first child. She reported that she was never given a chance by her physician to see if her blood pressure would recover on its own after pregnancy, she just put on blood pressure medications, penicillin allergy (From: Unspecified To: Ongoing), she was overweight and had depression and suicidal thoughts with certain medications (From: Unspecified To: Unspecified). The patient reported that almost all antidepressant drugs and certain pain killers for arthritis caused her to have depression and suicidal thoughts. She did not provide details regarding which medications caused her to experience depression or suicidal thoughts. She had sensitivities to medications (From: Unspecified To: Ongoing). She reported that she cannot take any generic form of Imitrex, she can only take the brand name. Also reported that the medication sensitivity runs in her family. Her daughter was allergic to penicillin and had a moderate to severe reaction to the pertussis vaccine at 6 months old. The patient reported that her daughter could not take anything with the ingredients in that vaccine. She reported that her mother also almost died from anaphylactic shock from a penicillin drug. The medication sensitivities run right down the female family line. She did not provide details for medication that resulted in her mother's anaphylactic shock. The historical vaccine of the patient included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0167) via an unspecified route of administration on 30Apr2021 on left arm as 1st dose, single dose for COVID-19 immunization. It was reported that the patient did not receive any prior Vaccinations (within 4 weeks): and did not report any adverse events following prior vaccinations. The concomitants medications included lisinopril and hydrochlorothiazide (Start: Unspecified Stop: Ongoing). The patient reported that she has been taking lisinopril and hydrochlorothiazide since she was 32 years old for blood pressure. The patient reported that she was aware of all the side effects and everything, and kind of knew what to expect. After the second dose on 21May2021 caller reported that much to her surprise at 21:00 hours, her physical side were extremely mild. Body temperature running 2 degrees higher at 98.8 or 99.2 and she still felt ok. She reported that her body temperature normally runs a little low, 97.2 degrees F or 97.6degrees F. The same day she experienced arm site injection pain, she applied Aspercreme and CBD oil. The same day patient also experienced headache. She reported that she does not have a primary care physician. She was drenching sweat she experienced told her that she was running a low-grade fever. She reported that the elevated temperature continued through the night and into the morning of 22May2021. She reported that her body temperature returned to normal after she had the second episode of drenching sweat around 2:00 PM on 22May2021. She reported that she was done with the paranoia and was worried about if the paranoia was coming back, she would not think it was funny. She reported that she got the Covid-19 vaccine because she does not have health insurance and she is also 63, overweight, and has high blood pressure. She stated why would you not get the Covid- 19 vaccine if there was no charge for it and it could save your life and keep you out of the hospital. She stated that the pros of the Covid-19 vaccine outweigh the cons. She does not want other people that have the same issues with the Covid-19 vaccine affecting their mental health to get caught by surprise and think that it was permanent. She woke up the next morning on 22May2021 and did not even think about the arm pain. All the physical stuff was a walk in the park. She did not expect and what took her by surprise was that she was an emotional basket case on the morning of Saturday, 22May2021. She reported that she has had this side effect with various other drugs in the past. At first she did not put two and two together because thats how far removed it has been since she had this reaction to the other drugs. She inquired if becoming an emotional basket case was a known side effect of the Covid-19 vaccine and inquired if mental impact of the Covid- 19 was part of the study and if mental health questions were part of the surveys completed by patients. She reported that emotional changes for her can be associated with certain medications that she takes. She reported that antidepressants in particular will send her into a tailspin. She was encouraged to continue taking antidepressants in the past but stopped when she began feeling suicidal. She did not provide product details for the antidepressants that she experienced adverse events with while taking. She reported that she was basically on a 100% raw organic diet. After she had the second episode of drenching sweats, all of her side effects left. She stated that people may want to know that mental side effects of the Covid-19 vaccine are temporary and that it might happen. On 22May2021, she experienced emotional side effects stating she felt paranoid and was crying. She stated that this had been reported or evaluated for in the trials. The outcome of the events was crying, a low-grade fever and worried was unknown and rest of the events recovered on 22May2021. It was reported that the patient did not require emergency room or physician office visit. Information on Lot/Batch number was available. Additional information has been requested.
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| 63 | 2021-06-01 | excessive sleepiness |
severe headache, between the eyes, worsened; very bad cough, she woke up with it, its hard to breath...
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severe headache, between the eyes, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; yesterday she was tired when she got her shot, yesterday morning she slept all day; she was not really hungry; yesterday she was tired when she got her shot, yesterday morning she slept all day; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 11:00 hours, as single dose (at the age of 63-years-old) for covid-19 immunisation. Patient had no medical history. Patient stated that she had no problems, no medications, no heart problems, no diabetes, she was free and clear of medication. Patient had no family medical history relevant to events. Patient stated that a couple family member been vaccinated, and they did not had a problem. The patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 07Apr2021, patient got her shot at 11:00 hours and patient were tired when she got her shot and in morning patient slept all day, she did not eat because she was not really hungry, she had a headache between the eyes and it was odd for her to not be hungry. Patient stated that it happened after the first shot. Patient had severe headache and cough happened in the middle of the night, and can't breathe (on 07Apr2021). Patient had a bad cough, she woke up with it and it was hard to breathe with the cough (on 07Apr2021). Patient asked if she could take ibuprofen for headache and she was wondering if the cough was normal and can she take cough syrup. She stated that she needs something, she was coughing and hacking. Patient stated that every time she coughs her head was pounding. She could not eat and she was an eater. Patient said that she tried to get coffee down this morning and forget it, she was not really feeling hungry (on 07Apr2021) which was unusual for her, normally she would eat whatever you put in front of her. She didn't eat anything right now. As far as tiredness she was ok, not tired right now. Patient stated that she did feel tired (on 07Apr2021) yesterday but feels uncomfortable with headache and cough. Patient had no emergency room and physician office visit. Event severe headache, between the eyes and very bad cough, she woke up with it, it was hard to breathe with the cough was worsened. The outcome was recovered for yesterday she was tired when she got her shot, yesterday morning she slept all day (tired) on 08Apr2021, not recovered for (very bad cough, she woke up with it, it was hard to breathe with the cough, worsened), (severe headache, between the eyes, worsened) and unknown for rest of the events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 63 | 2021-06-02 | impaired work ability |
A cough that is different than anything I have ever heard or had. Had it over a month and it hasn't...
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A cough that is different than anything I have ever heard or had. Had it over a month and it hasn't gotten any better. It chokes me sometimes and one time I stopped breathing because I was choking. Energy level very low and usually I have a lot of energy and never get tired. It is hard to do a little bit of work and I used to go go go all day. Labored breathing often. Fatigue.
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| 63 | 2021-06-06 | mental impairment, fear, disorientation, memory impairment |
Two days after the vaccine I woke up achy and with a slight fever. Not long after I woke up I began ...
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Two days after the vaccine I woke up achy and with a slight fever. Not long after I woke up I began having trouble thinking through sentences and had some trouble speaking. I goto up to get some water and was dizzy. I walked into the wall repeatedly. During the rest of the day I couldn't remember anything from one minute to the next. Cognitively I couldn't put things together. It was terrifying,like being in a box and not. being able to get out. This lasted for about 24 hours.
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| 63 | 2021-06-07 | feeling abnormal |
Fever - 102F starting 12 hours after vaccine and subsiding 48 hours after. Body aches - starting day...
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Fever - 102F starting 12 hours after vaccine and subsiding 48 hours after. Body aches - starting day after and ending after 48 hours. Vertigo (spinning) starting 10 days after shot and continuing off and on to this day. Dizziness - starting 10 days after shot and still a problem daily. Nausea - with episodes of vertigo. Feeling off balance - same time frame as dizziness Tinnitus - same time frame as dizziness - constant. Blurry vision - same time frame, 3-4 days a week. Increased eye floaters - same time frame. Brain fog - comes and goes. Motion sickness triggered by riding in a car or side motion in my field of vision. Sensitivity to sound. Sensitivity to light.
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| 63 | 2021-06-07 | nervousness, insomnia |
A couple of hours or so after the second vaccine my body felt achy and feverish. Also started to g...
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A couple of hours or so after the second vaccine my body felt achy and feverish. Also started to get the chills and then a headache. The symptoms gradually got worse over the course of time, took a couple of Advil and went to bed. It was difficult to sleep as my legs ached so badly I could not get into a comfortable position. As the night progressed and and fell in and out of sleep, the pain and especially the chills and headache were unbearable. I woke up around 10-11 pm with my throat numb, feeling tight, my tongue was numb at the back and the front area of my tongue was numb and tingling. I was nervous and scared to go back to sleep. My family all asleep and did not want to unnecessarily awaken them. I put myself into an upright position for fear of anaphylaxis. Considered calling 911= but we live in a quiet community and waited to see if it got worse. I did not sleep all night, finally got some rest while sitting upright. The following day all the symptoms were there and fever, chills and body aches worsened. My temp was around 101. Drank a lot of water. Today, my throat does not feel the same. Feels like something is there but cannot describe the feeling. Have been tired these past couple of days. Not usual for me but cannot say it is due to the vaccine. I will comment in that I never had the chills so bad as I had experience with actually being sick. Was horrible.
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| 63 | 2021-06-08 | anxiety, depression |
I am doing better now. Received the vaccine on Saturday about 2:30 pm, and felt fine until later th...
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I am doing better now. Received the vaccine on Saturday about 2:30 pm, and felt fine until later that night when I had serious muscular pain. The following morning I felt fairly well, until about noon or 1 pm, when I had chills, low grade fever and fell into a very serious mood swing/ depression which is very unusual for me (almost suicidal depression). Monday, I had more muscular pain and had trouble with my right wrist. I continued to have serious low mood but by Tuesday morning was better (not as seriously depressed). I still have low to mid level anxiety, but I am starting a new job which might be part of that. All other symptoms are now gone, including the serious depression. I simply thought it should be noted.
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| 63 | 2021-06-08 | feeling abnormal, amnesia |
I had a foggy brain. I'm forgetting stuff, I have impaired vision, dizziness, off balance. I got an ...
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I had a foggy brain. I'm forgetting stuff, I have impaired vision, dizziness, off balance. I got an MRI done Extremic disorder, fatigue, headaches. Swollen in my legs, extreme dry eye, blurred vision. I have chest pains on and off. I had to see a Neurologist. And I am still under doctors orders. I am now having allergic reactions that I have taken in the past before the vaccine. I went to an ENT doctor. I have to get a psychological test. I have to take a balance test. I have to see a Cardiologist.
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| 63 | 2021-06-08 | sleep disorder, restlessness |
Headache worsening after about 6 hours and pain at injection site. Headache continued during the ni...
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Headache worsening after about 6 hours and pain at injection site. Headache continued during the night, with restlessness, muscle soreness preventing sleep. Headache continued after getting up around 7 am, with nausea. Started drinking water, vomited around 10 am. Ate 2 pretzels, drank ginger ale. Fever of 99 degrees, chills. Took tylenol. Vomited around 2 pm. Tool Emetrol. Headache worse. Vomited at 4pm. and again at 6 and 8. Went to ER at 9. Vomited 2 more times while waiting. Given meds for vomiting, pain and IV fluids around 11:30 pm.
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| 63 | 2021-06-09 | anxiety |
She got the vaccine about 5:30 PM May 24, 2021, and initially did fine. In the middle of the night ...
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She got the vaccine about 5:30 PM May 24, 2021, and initially did fine. In the middle of the night she awoke short of breath, coughing, felt she could not breathe. She denied any itching or hives. Denied any swelling in throat or mouth. Tried antihistamine. Next day, went to work, still short of breath, and in mid day came to see us in the office. She was wheezing and oxygen saturation was 89%. ( 96% is normal), and hypertensive. RR was 24-30. BP was 160/104. We sent her to ER for possible anaphylaxis to covid vaccine. In ER was treated with albuterol nebs, duonebs, prednisone, and admitted to the hospital on 8 liters oxygen. She was in hospital 5/25/21 to 5/27/21 and sent home off oxygen, on prednisone DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety, COPD exacerbation (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)
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| 63 | 2021-06-09 | impaired work ability, feeling abnormal |
01/08/2021 - The shot did hurt. The next morning, I felt bad, I went to work and they scanned my tem...
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01/08/2021 - The shot did hurt. The next morning, I felt bad, I went to work and they scanned my temp, I felt fatigued and feverish. I took the next few days off work.
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| 63 | 2021-06-10 | sleep disorder |
Numbness; tingling; moderate to severe pain in right hand; It wakes me up at night, it's so bad; Vis...
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Numbness; tingling; moderate to severe pain in right hand; It wakes me up at night, it's so bad; Visual disturbances (floaters in left eye constantly).; This is a spontaneous report from a contactable Nurse (reporting for herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, via an unspecified route of administration administered in Arm Right 23May2021 at 12:00 pm, as single dose for covid-19 immunization (at the age of 63-years-old). The patient medical history was not reported. The patient was not patient diagnosed with COVID-19 prior to vaccination and since vaccination has not been tested positive for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); trazodone (TRAZODONE) and hydrocodone bitartrate, paracetamol (NORCO) all were taken for an unspecified indication and start and stop date were not reported. patient previously experienced allergy while taking codeine, Ativan and augmentin bambini. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on 2May2021 at 12:00 pm, as single dose for covid-19 immunization. Caller stated that after receiving second dose of vaccine on 26May2021 08:00 am the patient experienced numbness, tingling, and moderate to severe pain in right hand. it wakes me up at night, it was so bad. visual disturbances (floaters in left eye constantly). Patient visited to the emergency room/department or urgent care for the events. The outcome of the events was not recovered. Information lot/batch number is requested.
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| 64 | 2021-01-05 | sleep disorder |
I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness o...
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I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.
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| 64 | 2021-01-06 | impaired work ability |
Five minutes after receiving the Pfizer Covid-19 vaccine, the pt. informed the RN that she was feeli...
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Five minutes after receiving the Pfizer Covid-19 vaccine, the pt. informed the RN that she was feeling "itchy" on her right arm, her right scapula and across her abdomen. She was given the vaccine in her left arm. The pt did not have any rash or hives noted. The PA spoke with the pt and 50 mgs Benadryl was given p.o.(@ 1450). The pt stayed to be observed and after an additional 40 minutes (@ 1531) she said she was feeling better and was going to her unit to work (eve shift). The pt. spoke to her Nurse Manager upon arrival back to her unit and was sent home instead of working. Her unit was called at 4pm and we were informed that the pt went home, as she was concerned of being too tired to work.
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| 64 | 2021-01-08 | impaired work ability |
Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should ...
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Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.
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| 64 | 2021-01-08 | poor quality sleep, anxiety |
Dizziness, HYPERtension & Tachycardia Narrative: 5 min after vaccine administered L arm felt dizzy. ...
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Dizziness, HYPERtension & Tachycardia Narrative: 5 min after vaccine administered L arm felt dizzy. 170/100, HR 133, 97% RA at 1220. Reported poor sleep and mild anxiety. 115/76, HR 116, 96% RA at 1234. At 1237 denies any dizziness or other adverse effects.
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| 64 | 2021-01-11 | delirium, feeling abnormal |
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including finger...
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Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
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| 64 | 2021-01-11 | feeling abnormal, anxiety |
Customer rec'd COVID-19 vaccine at 0907 in facility and transferred to post vaccine observation. At ...
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Customer rec'd COVID-19 vaccine at 0907 in facility and transferred to post vaccine observation. At 0917 customer called out to provider. Customer reports "a funny feeling" and states that she has commonly felt this feeling prior to allergic reactions. She appears anxious. Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports "heart racing." BP 205/100, HR 121, 02 98%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 0920. Customer monitored at site. Over the course of the next 5 minutes she reports feeling better and more relaxed. HR decreases to 78, BP 190/78 @ 0930. Customer reports full resolution of symptoms. Reports having this type of reaction before to oral medications and has previously been monitored in the ED. She denies ever having to receive EPI, and is unsure what treatments were given in ED to resolve symptoms. She has never been admitted for one of these types of reactions, and reports this reaction as a mild compared to others. Customer's husband called to bedside. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1005, ambulating independently with steady gait, no obvious s/sx of distress.
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| 64 | 2021-01-12 | crying |
Vaccine was administered on 12/30 at around noon. I felt fine that day but was aware that a previou...
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Vaccine was administered on 12/30 at around noon. I felt fine that day but was aware that a previously diagnosed but inactive area of contact dermatitis on my right knee was flaring up - becoming very pruritic and active. Over about 48 hours it became red, blistered and eventually weepy. The area had been biopsied in September of 2020 ("spongiatic dermatitis"), treated with topical steroids and for the most part resolved. I saw my dermatologist on 1/6 - repeat biopsy was done ("severe allergic reaction") and it was treated again with topical steroids and is resolving. On 1/12 I began experiencing generalized pruritus. I have patchy erythema, dermatographism, and a few scattered solitary urticarial lesions. There are no respiratory symptoms - specifically no shortness of breath, cough, bronchospasm, swelling of mouth, lips or tongue. No joint pain. No fever. I took zyrtec 10 mg with minimal improvement. I contacted my dermatologist today who feels this is an Id reaction and suggested reporting the reaction to VAERS. I have also contacted my primary physician and have a telehealth visit scheduled. The biggest question is whether to have the second dose of the vaccine, as I am a physician actively seeing sick outpatients.
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| 64 | 2021-01-12 | feeling abnormal |
Immediately felt "strange" after receiving the vaccination. Developed hypertension, muscle aches, e...
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Immediately felt "strange" after receiving the vaccination. Developed hypertension, muscle aches, extremity swelling.
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| 64 | 2021-01-12 | impaired work ability |
Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to...
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Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.
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| 64 | 2021-01-12 | sleep disorder |
awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu...
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awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu-like sx lasted for one day; fever resolved by this am 1/13
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| 64 | 2021-01-12 | sleep disorder |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
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| 64 | 2021-01-12 | sleep disorder |
Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle ...
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Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle of night with severe bilateral leg pain, similar to sciatica, painful to get out of bed and walk, similar to Charlie Horse. She took Tylenol and laid around most of the day 1/11/21. Pain in right leg stopped in evening on 1/11/21, however pain continues in left leg. Nerve pain in left leg is still continuing from left gluteal muscle to inner thigh above knee cap. She declined occupational health follow-up and will self-manage at home. Pfizer-BioNTech COVID- 19 Vaccine
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| 64 | 2021-01-12 | sleep disorder |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days
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| 64 | 2021-01-14 | impaired work ability |
Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive saliv...
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Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift
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| 64 | 2021-01-16 | sleep disorder |
I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entir...
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I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entire area was in pain. I could not been over without twinges of spasms. I could walk without problems--including up and downstairs (with extreme caution). On 1/16/21 I started taking Bayer for Body and Back pain and using Icy Hot on the area that hurt. I called my doctor's office for med for spasms and she said I need to see a doctor. I wanted to be compliant with her recommendations. The doctor suggested Extra Strength Tylenol every three hours.
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| 64 | 2021-01-17 | impaired work ability |
After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart...
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After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart was pounding check my BP 150/80 laid back down. I woke up around 5pm my BP had elevated to 160 (don't remember diastolic reading) pulse rate normal limits. I informed my spouse of what was happening called 911. At the hospital checked vitals, EKG, CT Scan, Chest X-ray, Blood work and Potassium was low took 2 Potassium pills. I went back home on 12/31 returned to work did fine that day. On New Years day everything started back again discomfort went back to ER. I felt like force in my chest the doctor collected my information and I was placed on a low dose BP medication until I return to my PCP, cardiologist(stress test). I followed up with PCP via Telehealth about my BP concerns, my dosage was increased to 25 mg and due to my symptoms I was placed on leave from work 2 wks. I also have a appointment scheduled with Neurologist.
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| 64 | 2021-01-19 | mental impairment |
Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji ...
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Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report
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| 64 | 2021-01-24 | confusional state |
bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time)...
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bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
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| 64 | 2021-01-24 | feeling abnormal, impaired work ability, anxiety |
forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most...
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forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-01-27 | loss of personal independence in daily activities |
patient developed a fever right after injection, went up to 103.5 overnight, called off work the fol...
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patient developed a fever right after injection, went up to 103.5 overnight, called off work the following day sick - headache and vomiting
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| 64 | 2021-01-28 | anxiety |
Patient experienced tachycardia/anxious during 15 minute monitoring period after receiving first dos...
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Patient experienced tachycardia/anxious during 15 minute monitoring period after receiving first dose of Pfizer lot# EK9231. Patient was kept for an additional 15 minutes and improved within 10 minutes of the dose. Patient received vaccine on 1/15/2021.
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| 64 | 2021-01-28 | anxiety |
HR 80, 98 SPO2 on RA, 170/98 , 2 160/92, 99 % RA HR 98, 99 % HR 88, 160/90 Pt states she feels dizzy...
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HR 80, 98 SPO2 on RA, 170/98 , 2 160/92, 99 % RA HR 98, 99 % HR 88, 160/90 Pt states she feels dizzy, denies pain at the site. Says she does have DMII and HTN. Ambulated to restroom with RN, given bottle of water, states she has not eaten all day, states she feels anxious and vision is blurry. Pt denies headache, weakness, pain, nausea. Patient verbalized understanding to f/u with 911 or ED with any further problems. Pt also signed hardcopy.
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| 64 | 2021-01-28 | feeling abnormal |
Patient was at end of 30 minute monitoring and stated she "felt off, my throat feels dry." Able to s...
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Patient was at end of 30 minute monitoring and stated she "felt off, my throat feels dry." Able to sip water. Continuously monitored for additional 10 minutes when she stated her throat felt tight. BP 150/85, HR 97, RR 20, p. ox 99%. Sent to critical bed in emergency. Epinephrine, Solu-medrol, and normal saline given. Monitored until 11:18 (3.5 hours from onset) and discharged.
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| 64 | 2021-01-28 | mental status changes |
Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site an...
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Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site and fever of 103.
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| 64 | 2021-01-30 | loss of personal independence in daily activities |
Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like...
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Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like blue blazes, itched intensely, and I had a fever of 102.4. To get my temperature down to 100 degrees I had to alternate Motrin and Advil. I continued to have a fever, headache, body aches, chills, and lethargy for the next 48 hours and stayed in bed because I felt so awful. Unable to do normal activities of daily living.
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| 64 | 2021-02-01 | fear |
Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with ches...
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Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with chest tightness; A little atelectasis in lower left lung; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left deltoid on 14Jan2021 09:00 at single dose for covid-19 immunization. Medical history included ongoing does not have a thyroid; allergies/intolerance to gluten and dairy, allergies to molds, dust and some seasonal allergies; all ongoing. Concomitant medication included levothyroxine from Feb2013 to unspecified date, from unspecified date and ongoing for "does not have a thyroid". The patient previously took codeine and experienced allergic reaction occurred at 13 years of age with unknown cough syrup with codeine, levaquin and experienced allergic reaction occurred probably while she was in her 20s (age in years). She had fallen asleep on the couch about 9:00 pm on 14Jan2021. She woke up about 9:30 pm on 14Jan2021 and had an elevated pulse with chest tightness. She had to go to the emergency room in response to elevated pulse with chest tightness. In the emergency room they were not able to do anything other than hydrate her and all of that but it took about 12-13 more hours for her elevated pulse to come down (15Jan2021). Her biggest question was that she saw where some reactions are fast heart beat but she was kind of surprised at how long after the dose was administered that she had onset of the elevated pulse. She saw Cardiologist 18Jan2021 related to this event and the Cardiologist was a little baffled by the event. She reported event as improved, although she still has a little bit of tightness in her chest which goes in a little bit of phases. The Cardiologist told her to still take the second dose as scheduled of the Pfizer COVID-19 Vaccine. She did not see her family doctor, she saw the Cardiologist only as referred after emergency room visit. She was not admitted to the hospital; she was treated and kept under observation in the emergency room for about 5.5 hours. She has a stress test scheduled for next week. She is planning to still get the second dose as scheduled of Pfizer COVID-19 Vaccine but she is a little scared to get it due to this adverse event. She thought the events were related with the vaccine, she had no problem prior to getting the vaccine. On 14Jan2021, pulse was 146 beats per minute which she checked with a pulse oximeter machine she has at home so she knows it is accurate; Chest x-ray: She reported that result of a little atelectasis in lower left lung was a little weird. On 18Jan2021, the EKG result was Normal sinus rhythm but throwing PVCs. She reported she knows her thyroid lab is normal because it was checked in the emergency room during visit starting 14Jan2021. The outcome of the events elevated pulse with chest tightness was recovering, other events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-02-01 | impaired work ability |
Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; N...
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Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 64 | 2021-02-03 | abnormal dreams |
My arthritis pain is gone; vivid dreams; This is a spontaneous report from a contactable consumer. ...
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My arthritis pain is gone; vivid dreams; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 12Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to IVP DYE, and osteoporosis from an unknown date. Concomitant medication included alendronate sodium (ALENDRONATE). The patient previously took varicella zoster vaccine (shingles vaccine on 03Dec2020), and povidone in generic tablets and experienced allergy. On 15Jan2021, the patient experienced her arthritis pain was gone. The patient also mentioned that she had vivid dreams in Jan2021 and haven't dreamed in years. The outcome of the event swas unknown. The patient did not received treatment for the event. The patient diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
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| 64 | 2021-02-04 | delirium | razor sharp pain at injection site delirious with fever chills whitening of skin lasting 5 hours |
| 64 | 2021-02-04 | feeling abnormal |
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes...
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Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
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| 64 | 2021-02-07 | restlessness |
Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, te...
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Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, temp came down. The next day, she experienced chills, joint pain, body ache. The next day, still had symptoms but not as bad. She is getting back to normal but is still having some mild symptoms.
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| 64 | 2021-02-08 | feeling abnormal |
Immediately following injection the patient developed paresthesia's of the lips. Six days later he d...
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Immediately following injection the patient developed paresthesia's of the lips. Six days later he developed symmetrical paresthesia's of the lower extremities that have progressed up the legs to the knees bilaterally. Additional symptoms include brain fog, fatigue and migraines with increasing frequency. Symptoms have continued to progress now one month later. No treatment. Pending neurology evaluation.
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| 64 | 2021-02-09 | insomnia |
Severe rash began on 1/25 , about 11 days after second dose of vaccine. Rash was erythematous, was ...
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Severe rash began on 1/25 , about 11 days after second dose of vaccine. Rash was erythematous, was not raised. Began on chest then spread all over body. Extreme pruritis, relieved for only 2 hrs after doses of 50 mg Benadryl each time. Took Prednisone 20 mg on 1/27 then 40 mg on 1/28 with no relief. On 1/29 went to ER because of exhaustion due to not sleeping secondary to pruritis. In ER was treated with IV Decadron, IV Pepcid and IV Benadryl. CBC and BMP were normal. Dermatologist was contacted by ER via phone . Felt reaction was due to the vaccine and to report it . I was prescribed Claritin 10 mg QID and Pepcid 40 mg daily. Rash resolved after 48 hrs. No SOB.
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| 64 | 2021-02-10 | anxiety |
Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; ...
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Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-02-12 | nervousness, confusional state |
During the first 10 minutes of shot, while in the store, I got a mild chest pressure. Did not think...
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During the first 10 minutes of shot, while in the store, I got a mild chest pressure. Did not think anything of it at first. Thought might have been heartburn or nerve. However, it persisted along with periods of mild and sometimes a bit more moderate chest pain for about the next 8 hours but never got sever. Around 11:30 p.m., I decided to lay down and if not gone in a couple of hours, I would go to E.R. I feel asleep and when I woke around 2:00 a.m., the discomfort was gone. The next day I looked on internet because flyer given did not say anything about chest pressure and pain, just difficulty breathing, but I found a site that listed "persistent chest pain and pressure" as an adverse reaction. I am now wondering if this was considered an adverse reaction and if I need to be concerned for the next dosage. I have left a message for my physician, and plan to call pharmacy today. I want to get the next dose for protection but now I am nervous. Can you advise? I have listed my cell number, or please contact via email. I am so confused as to what to do. Thank you.
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| 64 | 2021-02-14 | disorientation |
fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, ...
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fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )
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| 64 | 2021-02-15 | sleep disorder | On 2/7 at 01:00, woke up with headache, chills, fever, nausea and increased arm pain. |
| 64 | 2021-02-16 | impaired work ability |
I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomi...
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I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomiting within a couple hours. Around noontime I vomited twice more. I got worse, could not walk around. I felt extremely sick but felt better when I lay down in bed. I was not able to go to work, had to cancel the substitute teaching assignment I had taken. I did sleep some. No doctor called me back except my daughter texted with me. She is an intern, said she wished she could be with me. My neighbor brought some Pedialyte. This morning, the next day, I am still weak and nauseous, but it is less. At the end of the day yesterday, I did eat a little rice with carrots. And I just ate a little plain oatmeal with raisins and salt. I am praying the 2nd dose will not be worse, as my daughter warned, because I can't remember when I was so sick and incapacitated. Maybe a long time ago.
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| 64 | 2021-02-20 | impaired work ability |
When trying to drive to work the next day, I experienced extreme light sensitivity. While I am ligh...
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When trying to drive to work the next day, I experienced extreme light sensitivity. While I am light-sensitive in the morning when the sun is low on the horizon, especially when there is snow on the ground, as was the case that morning, this was far more extreme than usual. I was wearing a very good pair of sunglasses I bought at an eye-doctor's office that protected from both the front and the sides. Still, I felt as though I had a strobe light flashing directly into my eyes. I was driving through town, in very familiar area, I realized when I got out of town into less familiar area, it would be unsafe to drive. I went back home and called work and told them I was not well enough to go to work that day. I later called the nurse who gave the vaccine and explained the situation to her. I received no treatment. I had my eyes examined the next morning and was told to use eye-drops four times daily for at least two months.
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| 64 | 2021-02-22 | feeling abnormal |
I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt d...
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I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.
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| 64 | 2021-02-24 | anxiety | Lightheadedness, Dizziness, HTN, patient with severe anxiety, EKG done via EMS, Sinus Tachycardia. |
| 64 | 2021-02-27 | amnesia |
With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like e...
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With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like experience, muffled hearing, a foul taste in my mouth and altered state of eurphoria. Could not report symptoms but if had been asked directly could have. REalised half way driving home that I should not be driving. Eurphoria lasted for 24 hours. Was on phone constantly the next day for 7 hours straight without eating. Could not remember what some items were like a drone. Had to ask = that thing that flies with a camera. Short term memory loss that continues. Facial numbness began 48 hours after injection. Facial numbness continues changing in areas of right side of my face. Felt extremely vulnerable. Wore my same clothing for 4 days as I did not remember that I had clean clothing. Did not remember that I should notify medical personal until late 2/20.
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| 64 | 2021-02-28 | insomnia |
Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, an...
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Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine. I have had extreme insomnia since vaccine.
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| 64 | 2021-02-28 | memory impairment, depression, feeling abnormal |
Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next ...
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Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
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| 64 | 2021-03-01 | disturbance in attention |
About four hours after the innoculation, I began to get nauseous. Three hours after that, I had vom...
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About four hours after the innoculation, I began to get nauseous. Three hours after that, I had vomiting and diarreah that lasted most of the night. I had chills, aches and headache which tylenol helped relieve. I began to feel better 24 hours later but still experienced extreme fatigue. It is now Tuesday (vaccine on Sunday) and I am still fatigued and have trouble concentrating.
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| 64 | 2021-03-02 | anxiety | felt tingling in mouth, anxiety, fullness in throat |
| 64 | 2021-03-02 | fear |
Severe difficulty breathing; difficulty breathing frightened her; This is a spontaneous report from ...
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Severe difficulty breathing; difficulty breathing frightened her; This is a spontaneous report from a contactable consumer (patient). A 64 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), intramuscular (on the upper left shoulder) on 27Jan2021 09:20 (at the age of 64-year-old), single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism diagnosed about 14 years ago, breast cancer from Dec2017 and ongoing diagnosed in Dec2017, ongoing asthma she was diagnosed with asthma when she was 39 years old, surgery from an unknown date, she had surgery to correct a deviated septum and her asthma got better, she has high blood pressure after all the treatment. Concomitant medication included salbutamol (ALBUTEROL). On 27Jan2021 she had the first injection. It was about 14 to 16 hours after the injection that she had severe difficulty breathing. Reported she has asthma. She was a cancer survivor, and she has high blood pressure after all the treatment. The difficulty breathing woke her out of her sleep. She had to call the doctor since she is concerned about her second dose which is scheduled for 17Feb2021. The difficulty breathing frightened her, and it was not an immediate reaction, she had the shot at 9:30 am (clarifies she received the injection at 09:20 am) and between 1 to 2 am in the night, she woke up not able to breathe. She could not use her inhaler since she could not really breathe in. She was obviously able to get some air in since she did not pass out. She contacted her doctor and he will send her a prescription to get an Epipen, so she has it on hand when she gets her second dose. Her doctor does not want her to not get the second dose. States she is concerned about other asthmatics receiving the vaccine and wanted to call and report this. She expected it to happen onsite where she received the injection but it did not. Her doctor asked her if she thought it was an asthma attack and she told her doctor that she has not felt like this in 24 years. Treatment/Outcome: She stepped out into the cold to shrink her airways and then was able to use her inhaler. Reports it was not a 2 hour episode thank god, and within 15 minutes she was able to force an inhaler dose in. Everything is fine. She is a breast cancer survivor and cannot use her right side so she had the injection on her left side in her upper shoulder, she has to wait 5 years to be considered cancer free. Her doctor suggested to use her albuterol inhaler for 4 days in advance of getting the second dose of the vaccine. She would think that would be abusing her albuterol but she will do that since she was instructed to do so by her doctor. She was terrified. She will have an Epipen on hand when she goes to get her second dose. She understands the symptoms can be worse with the second dose, she is anticipating everything should be fine. The outcome of the event difficulty of breathing was recovered on Jan2021, for the other event was unknown. No additional vaccines administered on same date of the Pfizer Suspect. No AE(s) following prior vaccinations, states she has had everything. No Prior Vaccinations within 4 weeks.
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| 64 | 2021-03-02 | nervousness |
very active stomach, diarrhea due to problem (nervous)/bowel movement really often; very active stom...
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very active stomach, diarrhea due to problem (nervous)/bowel movement really often; very active stomach, diarrhea due to problem (nervous)/bowel movement really often; Stool being dark is concerning; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL8982), intramuscular in right arm on 29Jan2021 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and had insulin resistance. She had her first dose of BNT162B2 on 03Jan2021. Concomitant medication included metformin. She also mentioned 'Candistan Clotrimazole' (not clear nor clarified) something like that, and also took 'Premarin' (not clear nor clarified) it's hormone for menopause. She got the vaccine instead of 21 days it was 26 days. Since when she had the vaccine, her stomach was really active, diarrhea due to problem (nervous). She informed having bowel movements like really often. Today (Jan2021), she already went twice but the thing was she was going and it was like too dark, mentioned that stool being dark was concerning. She took Libertrim S11 Trimebutine Simethicone, for diarrhea. The outcome of events was unknown.
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| 64 | 2021-03-04 | amnesia |
Approximately 7 hours after immunization, I experienced a change in orientation. I did not remember...
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Approximately 7 hours after immunization, I experienced a change in orientation. I did not remember getting a vaccination, day of week, month, color of my car, president. However, I knew my name, birthdate, people who were with me at the time of the event. I experienced no speech or mobility impairment. I was able to walk with no difficulty in my gate. My grasp was strong and equal. No facial muscle weakness was noted. 45 minutes later I had total recall of the day's activities. I am not a smoker, no consumption of alcohol or illegal drugs. Called primary care physician on 3/5/21 at approximately 4:30 pm. Primary physician was not available, spoke to a nurse.
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| 64 | 2021-03-04 | loss of personal independence in daily activities |
As the needle was being inserted and while the vaccine was being injected, I immediately felt intens...
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As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder. About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain. I suspected a severe inflammatory response. This pain level continued for the next 2 days. On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18. It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.) I believe my shoulder was injured by improper administration.
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| 64 | 2021-03-06 | feeling abnormal, sleep disorder |
Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep...
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Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep attacks, yet couldnt sleep, head just nodded up and down. felt very hot suddenly from the sides of the throat down straight and under both breast, felt as if I was being squeezed to death. chest felt very heavy. yet not gasping , or breathing fast. Im a respiratory therapist disabled now. I took bp was 120/80, o2 sat was 97, heart rate was 16, pulse 83. I could not lie down as felt as if being smothered. had to lie down but elevated very high. felt as if throat and chest were hot, but i did not get up to see if red, as i was having severe brain fog and oh so sleepy, yet felt so wired on friday evening March 5,2021 when I had the shot. I was awake, this tiredness and heaviness didnt happen until 1pm the next day. Saturday evening, I took o.1 ativan , thinking it was maybe anxiety as the brain for cleared after 3 hours, the chest heaviness got better, but still persisted over to sunday, march 7, but throat feeling closed in dissipated after 3 hours on saturday. 3/6. Sunday still unable to lie down as chest still felt heavy, bp 140/80 which was elevated. pulse elevated, respirations were 20. however all side effects seemed to be subsiding
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| 64 | 2021-03-07 | anxiety |
Extreme anxiety. I felt like I was coming out of my skin. Extremely anxious. I had to walk outside s...
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Extreme anxiety. I felt like I was coming out of my skin. Extremely anxious. I had to walk outside several times. Felt very fatigued. Not nervous but as if I couldn?t stay in one place.
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| 64 | 2021-03-07 | excessive sleepiness |
I was okay until after arriving home at which time I developed and headache and exhaustion. I went s...
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I was okay until after arriving home at which time I developed and headache and exhaustion. I went straight to bed for 2 days with headache, stomach pain, couldn't eat or drink. I started to feel a little better but still was unable to eat and was fatigued. When I did try to eat I got terrible diarrhea almost immediately. Over the next few days, realizing this was probably not normal, I contacted the advice nurse at my provider and eventually talk to a doctor on Friday (March 5). That doctor thought it sounded like I contracted COVID. I had a test that day that came back the next day negative. I have an appointment to talk to my regular doctor on Wednesday (March 10), particularly to get advise about whether to get the 2nd dose on March 20. My blood pressure has been unusually low (as low as 85/58) but is now about 120/60. I did not have a fever. My breathing has been more labored than usual, but my oxygen level is at 97% and my pulse is around 65.
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| 64 | 2021-03-07 | sleep disorder |
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling u...
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My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
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| 64 | 2021-03-08 | disturbance in attention |
One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. ...
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One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. I was extremely happy that I was NOT driving. I could not think straight and had sweat pouring down my face. My head was very heavy and as the day progressed, my neck also became sore. I took Advil and later Tylenol and they helped the head ache but not the dizziness. I lost appetite. I consulted the reading material about the vaccine and all of my symptoms were normal side effects, so I did not seek medical assistance. My daughter is a doctor and wanted me to report for statistical reasons.
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| 64 | 2021-03-08 | feeling abnormal, nervousness, hallucination, anxiety |
Hallucinations; Anxiety; Paranoia; She was nervous; she wasn't feeling right; This is a spontaneous ...
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Hallucinations; Anxiety; Paranoia; She was nervous; she wasn't feeling right; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, first dose on 25Jan2021, then second dose on 13Feb2021 both at single dose on the left arm, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension, both from an unknown date. Concomitant medication includes taking an unspecified medication for years, pain pills or whatever and the doctor said that it can take up to 7 days to leave the system. On 27Jan2021 at 10:00 am, 2 days after the first dose, it was reported that patient began to have hallucinations, anxiety, and paranoia. On an unspecified date in Jan2021 after the first dose, the patient reported that she was nervous, she is not feeling the same. The events continued after the second dose. She went to the Emergency room on Valentine's day 14Feb2021, she was not admitted and went home the same day. They just told her don't drive and talk to her primary Care Doctor. She then made an appoint for the primary care doctor on 17Feb2021. She has no other vaccines on the same day or in the 4 weeks prior. She has no other family medical history to provide. The outcome of the events hallucinations, anxiety, and paranoia is slowly going down and recovering while for the rest of the events was unknown. Information on lot number/batch number has been requested.
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| 64 | 2021-03-08 | impaired work ability |
The day after vaccine during the night I started coughing and feeling congested. Low grade fever and...
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The day after vaccine during the night I started coughing and feeling congested. Low grade fever and bas cough. Goopy eyes similar to pink eye and congestion and coughing. I did not go to work. I went to a clinic and they tested for Covid-19 the test was negative. Used compresses on the eyes and medication for cold like symptoms. The symptoms lasted an entire week. The cough hung around for three weeks after vaccine.
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| 64 | 2021-03-09 | anxiety |
at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=...
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at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=127/85, P=83, T= 99, O2 sat 98%. Appears anxious. Stating "Oh my god. I can't believe I am having a reaction" multiple times. Fanning herself with her vaccine card frequently. Placed in front of a large fan by this RN. Pt states that the wind feels good. has stopped fanning herself. At 1430 reports mild lightheadedness, no sweating and reports she is ready to go . When this RN turned around pt was gone.
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| 64 | 2021-03-09 | loss of personal independence in daily activities |
Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with s...
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Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with severe neck pain. Possible intermittent fever. Dizziness continued for 2 days. Neck pain improved somewhat but is still bothering me, woke me up at night. Now a week later and my neck still hurts. I called my primary care office on March 3 and they said call 211. That made no sense so I asked again and they finally said I could see a nurse practitioner the next day. However I didn?t go because I couldn?t drive. I am a little worried about the second dose.
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| 64 | 2021-03-10 | impaired work ability, sleep disorder |
Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when tryin...
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Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when trying to sleep at night. Pain when trying to do certain things at my job with my right arm.
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| 64 | 2021-03-11 | feeling abnormal, sleep disorder |
Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, ...
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Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained
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| 64 | 2021-03-11 | sleep disorder |
Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unab...
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Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.
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| 64 | 2021-03-12 | feeling abnormal |
Within 5 minutes of injection my eyes begin burning, my head started swimming and I could not focus ...
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Within 5 minutes of injection my eyes begin burning, my head started swimming and I could not focus my vision ,my heart was racing. I had no breathing issues and was able to get through it as it only lasted 6 to 7 minutes. But I'm very concerned as to taking the second dose? Please advise as to getting second dose
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| 64 | 2021-03-12 | nervousness |
When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rat...
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When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rate increasing. I immediately began to monitor my heart rate with my Watch. My resting heart rate is in the 60?s. At the time I looked at the watch my heart rate was already in the low 100?s but was rapidly escalating until in a matter of a few minutes had reached 140 bpm and my head began to have a full sensation and I was becoming very shaky. I pulled over into the parking lot of a restaurant and asked them to call 911. As they were talking with the dispatch my pulse started to decline so I cancelled the request. I stayed at the restaurant until friends to could come pick me up. By the time they arrived my pulse was in the low 100?s. I took 2 Benadryl. I monitored my BP through the night and it did not return to the 60?s until 1:00 am. I took (2) 25 mg Benadryl at approximately 4:00 pm, took another 2 at around 9:00 pm when my heart rate started to escalate and then a final 2 before going to bed at 1:00 am. My pulse dropped back into the 60?s while I was sleeping and stayed that way through the night. I woke up with no further symptoms nor side effects from the shot. The throat tightness and flushing of the ears resolved after the first dose of Benadryl. I had no adverse reactions or significant side effects from he first dose of Pfizer.
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| 64 | 2021-03-14 | feeling drunk |
3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'. 'ALSO NAUSEA AND FEELS DRUNK'. NO SOB/DYSPNEA. 7:16PM P...
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3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'. 'ALSO NAUSEA AND FEELS DRUNK'. NO SOB/DYSPNEA. 7:16PM PLACED IN W/C TAKEN TO MEDIC TENT & PLAACED ON CARDIAC MONITOR: NSR NOTED. 7:25PM STATES 'DECREASED NAUSE AND NO CHEST APIN NOW - STILL FEELS DRUNK'. PT DECLINES JUICE AND CRACKERS - STATES SHE WANTS TO WAIT AND TAKE HER DIABETIC MEDS BEFORE SHE EATS'. 7:30PM 'FEELING BETTER' TO EXIT PER W/C TO BE DRIVEN HOME PER DAUGHTER. 3-12-21 1PM TC: STATES 'NO CHEST PAIN , STILL HAS A LITTLE NAUSEA'.
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| 64 | 2021-03-15 | feeling abnormal | Symptoms: Loss of sense of taste, foggy brain, lightheadedness |
| 64 | 2021-03-15 | loss of personal independence in daily activities |
Report small lump to the left ankle 3 weeks post vaccination, not sure if it is related to the vacci...
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Report small lump to the left ankle 3 weeks post vaccination, not sure if it is related to the vaccine. States it was not there prior to the vaccine. Treatment: none . Outcome: Does interfere with ADLs. Recommend to follow-up PCP for any concerns.
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| 64 | 2021-03-15 | sleep disorder, feeling abnormal, depressed mood |
Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompa...
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Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompanied by mild mental fog, myalgia, intermittent low grade fever and marked depressed mood. Severe left breast pain and left axilla pain on the third day severe enough to wake from sleep. Lasted about 48 hours.
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| 64 | 2021-03-16 | anxiety |
HEART POUNDING, ANXIETY Narrative: Patient felt heart pounding a few minutes after 1st Pfizer covi...
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HEART POUNDING, ANXIETY Narrative: Patient felt heart pounding a few minutes after 1st Pfizer covid vaccine. VS: BP 148/90,P99, PO2 95& at 10:22. Symptoms subsided after 10 minutes. Repeat VS at 10:33 BP 147/89. P 87, PO2 100%. Probably anxiety. Released with instructions to seek care at Ed or PCP if symptoms recur.
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| 64 | 2021-03-16 | anxiety |
Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilatera...
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Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilateral occipital area. Some neck pain and traveling from neck to scalp. Today is 3/17/21 and the symptoms are still present but somewhat improved over the last week. The sensations are now mostly on the R side. I took Advil 400mg TID for 2 days and also applied a heating pad to the neck and back of head. I saw my PCP today as this is causing me a lot of anxiety, she prescribed Prednisone 40mg daily X 3 days.
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| 64 | 2021-03-17 | nervousness |
patient stated she felt like her blood pressure was going up right after vaccine administration. I t...
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patient stated she felt like her blood pressure was going up right after vaccine administration. I took her BP and it was 190/112. She got hot and then cold and shaky. I got her some water and propped her feet up and took her blood pressure 3 or 4 more times over about 20 minutes then we decided to call 911.
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| 64 | 2021-03-17 | sleep disorder |
Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily ...
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Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily in the right bicep I feel like muscle is getting weak. I have iced it and taken Advil and Tylenol. Nothing takes the pain away. Additionally the pain wakes me up from sleep.
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| 64 | 2021-03-18 | sleep disorder |
Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to wait...
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Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to waiting area for 15 minutes. Left to go home, my face cheeks started to turn red within the next 30 minutes. A couple of hours later my skin was tingling, itching, even inside my ears, around my ankles. Took some Benadryl, knowing that it was an allergic reaction, but it didn't help. Couldn't sleep, felt like my skin was crawling. Around 4 am my skin finally calmed down. Sent a message to my Dr. to let him know what happened. Still some lingering itching the next day. Today is Friday March 19, most everything is back to normal.
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| 64 | 2021-03-20 | feeling abnormal, sleep disorder |
post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 m...
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post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 minutes-slight drop in blood pressure (I've gone as low as 32/18 during a bad reaction so I know this time was a much smaller drop) 13 minutes-stomach pains started, these would continue throughout the night waking me, and lasted approximately 17 hours 30 minutes- sudden feeling of lightness in my body, and that a light had gone on 60 minutes-odd sensations in throat but did not feel swelling, simultaneously at 60 minutes-dizzy the next day, 10 bowel movements until 2 pm
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| 64 | 2021-03-23 | feeling abnormal |
Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am. AT 3 am awoke with c...
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Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am. AT 3 am awoke with chills and 102.5 fever, nausea and followed by sweats. This has continued thru 3/23/21, so far. On 3/23/21 fever maintained between 100 & 100.8. Still felt badly. Awoke this am 3/24/21, sweaty but no fever thus far. Feeling better.
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| 64 | 2021-03-24 | confusional state, disorientation, disturbance in attention |
Dizziness, disorientation, very bad headache on the top of my head, confusion, problems with concen...
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Dizziness, disorientation, very bad headache on the top of my head, confusion, problems with concentrating and comprehending, lightheaded, fatigue, sensitivity to light. I had a concussion 5-years ago from a car accident and recovered after one year. The symptoms of my concussion have returned within 30 minutes of receiving the Covid vaccine.
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| 64 | 2021-03-24 | excessive sleepiness |
101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph ...
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101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph nodes (L) armpit Lasted 24 hrs Slept most of the time treated with Advil
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| 64 | 2021-03-24 | sleep disorder |
On March 17, 2021 I got a really bad sinus headache and my sinuses began hurting. This headache is s...
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On March 17, 2021 I got a really bad sinus headache and my sinuses began hurting. This headache is still and issue. A few days later I got hot flashes at night and had disturbed sleep. The headache has at times caused ear ringing, but not all the time. March 23 I had chills at night. March 24th, I had chills all day. March 25 I still have the headache and my right arm hurts which is where I have lymphedema.
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| 64 | 2021-03-25 | anxiety | Tachycardia body was on fire high bp shaking Nausea feeling of impending doom headache |
| 64 | 2021-03-25 | feeling abnormal |
Nausea, vomiting and diarrhea (2 days) Dizziness and lightheadedness (2 days) Vertigo (has been 10 d...
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Nausea, vomiting and diarrhea (2 days) Dizziness and lightheadedness (2 days) Vertigo (has been 10 days and is currently happening) Ringing in the ears Brain fog (5 days) Symptoms are ongoing and have decreased only slightly as of this report
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| 64 | 2021-03-26 | memory impairment |
6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 ...
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6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 1/2 full days . tingling of hairline and under the eyes, eyes were blurry for two days, starting getting heart palpatations, and blood pressure high and resting heart rate low and other times blood pressure was real low and resting heart rate as high as 125 even at rest not due to exercise... this continued with the heart irregularaties for abour two weeks. . i experienced unusal forgetfulness and couldnt recall things I knew .. i had mild fatigue... 3 weeks later Im about 90 percent but a little sluggish. finally was able to do yoga(bending over ) weights,,walking,etc.
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| 64 | 2021-03-26 | sleep disorder |
Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24...
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Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24 hour later. I woke with a fever (my feet were especially warm) Body aches, especially my joints. Mild cough I have taken ibuprofen and acetaminophen, which help. This was my second Pfizer dose. Other than a mildly sore arm, I had no issues with the first dose
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| 64 | 2021-03-27 | anxiety |
Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she...
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Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. After 15 minute observation period pt informed nurse of slight dizziness and thinks its anxiety. She was evaluated by EMS and per EMS is okay to be discharged home. Vitals were WNL and pt was alert, oriented, and ambulatory at discharge. Assessment : Time of assessment 1503. Alert and oriented. Actions taken: Vitals sign taken Vitals WNL Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
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| 64 | 2021-03-27 | feeling abnormal |
Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingli...
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Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingling and pain in the other arm from the wrist up to my neck. The medics took me into a room to lie down for 30 minutes and it seemed to pass. I have felt off and foggy for the past 3 weeks. And now for the past 3 days, I have been feeling the same feeling of lightheadedness and dizziness that I had after the shot throughout every day. I am sure this is related to the vaccine. I never had anything like this in my life. I did not take the second shot and still feel awful. I have spoken to people who had the same immediate allergic reaction.
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| 64 | 2021-03-28 | anxiety |
Approximately 5 mins after receiving the 2nd dose of Pfizer COVID-19, patient reported she begin to ...
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Approximately 5 mins after receiving the 2nd dose of Pfizer COVID-19, patient reported she begin to feel faint and dizzy. She also reported feeling nausea. Patient was alter and oriented, no difficulty breathing. Vitals were taken, patient's O2 was 98, pulse 56, and BP 90 by palpitation. Second BP taken 5 minutes later, BP raised to 118 by palpitation. Patient sipped on water, was laid back in the car, and windows rolled down. Patient reported she mitral valve prolapse and when she gets anxious, she starts to feel faint. Patient continued to be alert and oriented and within 15 minutes after first feeling faint, she stated she was feeling better. Was able to walk from driver to the passenger side of the car, patient reported she felt better and vitals were normal.
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| 64 | 2021-03-28 | anxiety |
3-25-21 3:36PM PT 'FEELS SOB, ANXIOUS, CHEST TIGHT' . PT IS EXTREMELY ANXIOUS. STATES IT IS THE FIRS...
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3-25-21 3:36PM PT 'FEELS SOB, ANXIOUS, CHEST TIGHT' . PT IS EXTREMELY ANXIOUS. STATES IT IS THE FIRST TIME SHE HAS BEEN OUT OF HER HOME IN OVER A YEAR. WATER, BATTERY OPERATED FAN AND COMFORT GIVEN. A/O, PINK, W/D. 3:48PM PT STATES 'FEELING A LITTLE BETTER'. 4:13PM TO EXIT WITH SON TO BE DRIVEN HOME. NO ACUTE DISTRESS. GAIT BRISK AND STEADY.
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| 64 | 2021-03-29 | impaired work ability, feeling abnormal |
I have tinnitus...so loud I can not get away from it. I noticed it when I went to sleep last night. ...
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I have tinnitus...so loud I can not get away from it. I noticed it when I went to sleep last night. I had the shot at 3Pm Saturday. I woke up at 3:47 and started to feel terrible. Chills, severe congestion, head hurt so bad, nauseous, ached all over. I have never felt so badly EVER. at 3pm Sunday I took two tylenol and everything got better. I was fatigued but functioning. I still had a slight headache but was able to eat a light dinner. Monday I was so fatigued I could not drive or go to work. I had severe brain fog. Monday night I noticed how loud my ears were when I went to bed. I could not get away from the noise. today the brain fog seems to be lifting but I am still drained and not feeling great. no energy. I have heart palpitations and shortness of breath. At one point I had a pain in my chest and was concerned about a blood clot. That seems to have passed the palpiations remain.
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| 64 | 2021-03-30 | disorientation |
Patient was anxious before the shot was given. She was given orange juice and water to hydrate her ...
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Patient was anxious before the shot was given. She was given orange juice and water to hydrate her just in case. After the shot she passed out and was disoriented and nauseated when she came out. Paramedics were called for evaluation and they took her to the hospital due to continued weakness and vomiting.
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| 64 | 2021-03-30 | feeling abnormal |
Starting that afternoon I was sore all over and very tired, foggy and nauseous for 2 days. Those ...
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Starting that afternoon I was sore all over and very tired, foggy and nauseous for 2 days. Those symptoms continued for 2 weeks except the nausea. About 3 days in I lost taste and smell for 1 day. The loss of taste came and went for maybe 1 month. Sometimes now, I still have a loss of taste with certain foods and others do not taste like they used to taste.
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| 64 | 2021-03-30 | feeling abnormal |
1 day after, low grade fever/unsettled stomach/chills/dazed/fatigue 4 days after dizzy enough to hol...
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1 day after, low grade fever/unsettled stomach/chills/dazed/fatigue 4 days after dizzy enough to hold onto walls/headache/red & sore eyes watery/debilitating 5-7 days dizziness has decreased, not debilitating but still there when bending over, looking up, moving fast, unsettled stomach decreased but comes in waves still happening
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| 64 | 2021-03-31 | feeling abnormal |
5 minutes after injection, fogginess and sleepy. Sort of like being drunk. Did not want to talk. Let...
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5 minutes after injection, fogginess and sleepy. Sort of like being drunk. Did not want to talk. Lethargy and weakness. High BP. This was a much shorter time than after 1st one. Next day: left arm/hand/fingers had uncontrollable muscle movements, beginning about 9:30 am.
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| 64 | 2021-03-31 | feeling drunk, impaired work ability |
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt a...
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At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.
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| 64 | 2021-03-31 | sleep disorder |
It?s been a week since my second vaccine and I am still feeling very tired and I?m having trouble sl...
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It?s been a week since my second vaccine and I am still feeling very tired and I?m having trouble sleeping
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| 64 | 2021-04-01 | depression |
No pain and minimal if any soreness in left arm. The morning after I had three fleeting bouts of rec...
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No pain and minimal if any soreness in left arm. The morning after I had three fleeting bouts of recognizeable depression- like a dark cloud that very suddenly came on and departed within minutes. First two about an hour apart the third I was walking an hour or so later and a sudden feeling of depression came again. I laughed at it the third time as it was such an odd and unusual feeling while enjoying outside, this too was fleeting. No more symptoms other than some tiredness over the next week .
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| 64 | 2021-04-02 | feeling abnormal |
headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad press...
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headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad pressure in the back of her head; felt like her heart was skipping beats; heart rate and blood pressure seem to be very erratic; erratic heartrate; arm swelled up and was sore; arm swelled up and was sore; lump in throat; unwell feeling all over like she was going to pass out.; unwell feeling all over like she was going to pass out.; She kept getting an icky feeling; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [26Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot Number: EN6204), intramuscular, administered in right arm on 08Mar2021 14:10 (at the age of 64-year-old) at single dose for Covid-19 immunization. Medical history included high cholesterol, osteoporosis, high blood pressure, arthritis, stenosis of neck and spine, allergies to dust and cleaners (when she cleans, the bottom of her neck swells up huge); all were ongoing. She has very high cholesterol, she believes it was close to 400 the last time it was checked and that's why she was given Repatha which brought it way down, but she doesn't know if she can take the Repatha again. She also has quite a few allergies - allergic to cats, sulfa, grass and Pre-diabetes. She has a fair amount of allergies. Her doctor thinks she has some asthma because she has had a little trouble breathing at different times, but she doesn't have an inhaler or anything. She mentions asthma and allergies run in her family. The patient also stated that a majority of her life, has had low blood pressure until about 9 years ago when her father passed. States that her blood pressure had been out of control for 6 months and was then put on a low dose of Carvedilol, and eventually evened out. Concomitant medications included ongoing carvedilol taken for blood pressure; ongoing loratadine (CLARITIN) taken for allergies from 1996 (has been taking for 25 years); ongoing lansoprazole taken for acid reflux; ongoing rosuvastatin calcium taken for cholesterol since Sep2020; ongoing calcium; carvedilol (COREG) taken for blood pressure. The patient had a previous reaction to a cholesterol medication evolocumab (REPATHA) from 23Oct2020 to 23Oct2020 - her neck swelled up pretty big and she had hives on her chest, which ended up going away. Therefore, she doesn't know if she can take that again or not. The patient also previously took rosuvastatin calcium (CRESTOR) 5-6 months ago and it made her legs ache really bad; esomeprazole sodium (NEXIUM) and had the problem; lansoprazole (PREVACID) for acid reflux. She took Nexium which was a different product with different ingredients and her blood pressure was still high the whole day. States that her doctor had prescribed another brand, which had the same main ingredient as the Nexium, and told her to double up on it one night, so she did that and about an hour later she just about hit the floor because her blood pressure shot up to about 200 over 100 and something, so she talked to the pharmacist who said that this was not a normal reaction to the ingredients in Nexium, but it happened to her every time she took it. She had been taking Prevacid for a long time but then started to get an allergic reaction. Clarified that feeling like she was having an allergic reaction after taking the Prevacid at night, was something that she has just started noticing within the last month. Wondering if the 2nd dose of the Prevacid is too much. States that she still takes this in the morning but not in the evening. States that she has started taking 15mg at night from an over the counter version of the same medicine (Lansoprazole). She explained that she hasn't had any vaccines as an adult, she never has had a flu shot. About 5 years ago, she had a bat in the house for 3 days and the bat ended up hitting her in the head and forehead as they were trying to get the bat out of the house, so she ended up getting a rabies vaccine. She was wondering and hoping there were no interactions with that. With the rabies vaccine, she did have a headache. She had to get 4 or 5 shots and she did not feel well most of the time. It took a long time to pass for her to feel normal again. The caller received the first dose of the vaccine last Monday on 08Mar2021, after the shot and while waiting those 30 minutes, she felt a lump in her throat which lasted all day and the next day, but it went away. She confirms by 10Mar2021, she recovered completely. Her arm swelled up and was sore for a day and half on 08Mar2021, but that went away. She isn't worried about that. She also has a really bad headache and was very dizzy on unspecified dates. She is concerned about the dizziness. She has been driving, but about the second day after getting the vaccine, she was leaning over talking to her mom and she felt like she going to pass out. She didn't, but she felt like she was. She has been using hot packs. It's like she has a headache around her temples and the back of her head seems to be hurting. In fact, she put a hot pack there while waiting to speak to this call handler. She doesn't know if its tension or what. She didn't have hives or none of that from COVID vaccine which she was excited about, but she is so dizzy she can hardly stand. She can't get rid of the headache and dizziness. She wants to know whether or not to go ahead with the next vaccination. This is the 5th day of having this dizziness. She was thinking the dizziness was going to last for a couple of days, but its going on 5 days. Even just sitting, She states it's kind of scaring her. She was thinking it would just go away, but it isn't. Her heart rate and blood pressure seemed to be very erratic on 12Mar2021. She woke up this morning (12Mar2021) and her blood pressure was very high, but she checked it within a few minutes and was dropping low. Her heart goes fast and then slows down, but she has had problems with this in the past. The dizziness has been bothering her a lot, she has been afraid to drive. The patient had a blood pressure of 150/102 on unspecified date. On 17Mar2021, She mentioned she will see her HCP at 2:00 PM. She has already filed a report regarding the side effects she had. She filed a report and asked if she should get the second dose shot. However, she was informed if her HCP called, they may be able to provide her with more information. She was informed her HCP could call the medical line. On 26Mar2021, she stated that the first report was filed the first week and that during the second week, more not good things have been happening. She wrote down the report number from the first report but does not have it now. Since the vaccine, she has been having different symptoms; she is not sure if it is related to the vaccine but wanted to report it. She was a little concerned because she has allergies, stating she had just tried an injectable cholesterol drug and she did break out hives and her neck had swelled. States that she has not had any vaccines as an adult, so she was a little bit cautious anyway. She clarified that she did not have hives and did not have any breathing problems when she left. Stated that later that evening and the next day had a really bad headache and bad pressure in the back of her head, which she knew was typical. States that 3 or four times she felt a rush over her body and felt like she was going to pass out. That night and the next day (unspecified date), she was having breathing problems (was not breathing very well for 3- 4 days) and her chest was tight and she was starting to wheeze, and continued for about 3 or 4 days. She kept getting an icky feeling Monday and Friday when she got up and had unwell feeling all over like she was going to pass out on unspecified date in Mar2021. States she had real bad pressure in her head and high blood pressure and felt like her heart was skipping beats on unspecified date. States her blood pressure was around 152/100 on 09Mar2021. One-day blood pressure was real low, 88 over something but that kind of went away. States all that information was already reported. The next week, she thought she was feeling better and that Monday and Tuesday felt back to normal. Stated that on Thursday night (Mar2021), she was just sitting and around 8 o'clock her blood pressure spiked within a few minutes to around 184/105 and she wasn't doing anything; she couldn't get it to go down. States that she went to the ER to check everything out last Thursday. Every night since then, somewhere around 8 o'clock, her blood pressure spikes really high. Stated she then called her doctor. Stated she was on a really low dose of blood pressure medication, stating that she had occasional problems with her blood pressure in the past but it never went that high. Her blood pressure was usually in the 140's or 150's over 90 something. States that now it is much higher and happening every night. Caller stated that Wednesday night (24Mar2021) her blood pressure started to spike every 5 to 6 hours, stating it first started at 830 at night and again at 230 in the morning. She has been feeling unwell since that shot. Her doctor thinks it may be causing inflammation. States that they doubled her medication last night and her blood pressure is still going up and up, but usually goes down after a couple of hours. It is totally uncontrolled and her doctors are trying to figure it out. States that meds have been added, including Xanax and will be going to see a heart doctor. States that this has all been since the vaccine. Caller would like to know if people are reporting these symptoms. States that it is pretty terrible, and that she feels normal and then it rushes over her. States that it is exhausting and that she almost went to the ER last night. States that she does not want to go back if she does not have to. When she filed the first report she did not have issues with blood pressure yet. Again, she had the vaccine on Monday 08Mar2021 and that the next Thursday she felt like her heart rate was really high. During that first week, she felt out of rhythm, like missing beats. Her blood pressure dropped low the first week and that just one time was around 152/100 but it didn't sustain. It then dropped pretty low one day. The next Thursday, it was uncontrollable. It was around 180 over 104 or 105 and that it kept going up, but then back down to 160/90 something. Took Xanax and went to bed, when she woke up this morning it was low, but went right back up within 5 minutes. In the first couple of days, they increased her blood pressure medicine and it seemed to be bringing her blood pressure down and she was able to go to bed. The caller stated that Monday, it will be three weeks. States that a day and a half after the vaccine, her arm was not hurting but was still puffy, but not bad. States that when she runs her hands over it, it is still sore to the touch and a little swollen but nothing extreme. She was concerned that her blood pressure keeps going up and then down. States that the blood pressure started spiking on the 18Mar2021, in the evening very quickly and was very high. Stated that this was happening every night since then until the 24th, when it started spiking every 5-6 hours; and her blood pressure medicine wasn't controlling it like it was earlier in the week, even though the dose was doubled. For one day it worked good and brought it down low but then, it wasn't controlling it anymore. She stated no relevant tests, related to this event but states that in her last 2 labs her cholesterol was high. States that it was over 300 and her bad cholesterol double or more triple. States this has been going on for many years. States that she changed her calcium to calcium with vitamin D and her vitamin has come back up. When she was in the ER they did a Metabolic panel and everything looked okay. The adverse events require and emergency room visit. The patient recovered from the event lump in throat on 10Mar2021; the events arm swelled up and was sore recovered in Mar2021; the events erratic heart rate, chest was tight, was not breathing very well for 3- 4 days, wheezing resolved on unspecified date. The outcome of dizziness, blood pressure seem to be very erratic was not recovered and the outcome of the remaining events was unknown.
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| 64 | 2021-04-04 | loss of personal independence in daily activities |
pt states she started having left leg pain. She has muscle aches and pains in her leg so bad that s...
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pt states she started having left leg pain. She has muscle aches and pains in her leg so bad that she can hardly lift it and has not been able to climb her stairs in her house. She is sleeping sitting up since she cannot lay down. She says her pain level is still a 6 out of 10. Both feet are swollen and lower part of her legs are cold and stiff and the upper part of legs are warm. She has been taking naproxen 520mg to help with the pain. She says this has not helped with the pain. Pt will contact her PCP.
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| 64 | 2021-04-04 | mental status changes, confusional state | Meningo-encephalitis Pt started having fever, chills, altered mental status, drowsiness, confusion. |
| 64 | 2021-04-05 | feeling abnormal |
The next day following the vaccine my arm hurt slightly at the injection site, my head felt strange ...
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The next day following the vaccine my arm hurt slightly at the injection site, my head felt strange slight pressure maybe inflamed my face was red my blood pressure was higher for the first day. The following days my head felt strange again and my face would get red and it would come and go. but blood pressure was normal. Mid week the entire left side of my body felt like my body worked out but I didn't exercise. Today eight days after the vaccine blood was on the tissue after urinating in the morning upon waking again in the evening there was more blood on tissue.
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| 64 | 2021-04-05 | mental impairment, disturbance in attention |
For three days, fatigue and aching in neck and across shoulders. The aching went away, but I am stil...
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For three days, fatigue and aching in neck and across shoulders. The aching went away, but I am still fatigued and I feel groggy/sedated. I can't focus well, mentally, and my memory is affected.
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| 64 | 2021-04-06 | feeling abnormal |
She got her vaccine and after she received it she was okay, after 10 minutes she had a heated sensat...
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She got her vaccine and after she received it she was okay, after 10 minutes she had a heated sensation to her neck, and chest and radiated down her right arm to her finger. Her legs from the knees down went numb. She had waves of this that would come and go. Then her upper lip got numb decided to leave as feeling it may have been anxiety. On her way home in the car she had these reactions again and called her husband and told him that something was not right and that she felt weird. She talked herself out of going to the ER, and went home. She still was feeling really weird to be ok that came and went. She called her friend who is a nurse who told her to take Ibuprofen and to go to bed. She felt better after about 2 hours, and seemed to be doing okay periodically until the day before yesterday when she started feeling numbness in her legs, arms and then her upper lip which was pretty severe. The heat from the arm is burning and burns to her upper chest and neck. Yesterday morning she could hardly feel her feet saw a report of somebody getting Guillain Barre from it. She took an Aleeve PM to go to sleep. She woke up yesterday morning and the muscle pain was go but the numbness was still there. She called the CDC who told her to contact us and to get in touch with her PCP and she was seen by her yesterday who ruled out Guillain Barre. She examined her and said that her that the glands are swollen and relays the reaction to the injection and that may be causing the neurological numbness in her arms and legs. She put her on a 5 day steroid to see if that helps to alleviate her symptoms. She does feel better today but still having some numbness in the arms and legs, and swelling in her glands.
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| 64 | 2021-04-07 | abnormal dreams |
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and ...
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pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering. Additional information has been requested.
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| 64 | 2021-04-08 | panic attack, anxiety |
IMMEDITELY AFTER SHOT -- I FELT LIGHT HEADED AND MY BLOOD PRESSURE WENT UP TO 200/111. THEY TOOK A ...
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IMMEDITELY AFTER SHOT -- I FELT LIGHT HEADED AND MY BLOOD PRESSURE WENT UP TO 200/111. THEY TOOK A CARDIOGRAM AND THAT THEY STATED AT THE TIME, AS I RECALL, WAS GOOD. BP CONTINUED AND I WAS TAKEN TO ER (NYU HOSPITAL WITHIN 45 MINUTES. BP WENT DOWN TO APPROXIMATELY 160/96 AND THE HOSPITAL RELEASED ME AFTER MONITORING. I BELEIVE I WAS HYDRATEDD -- SINCE I UNDERSTOOD THAT IT WAS IMPORTANT TO DRINK WATER. MY BP HAS NOW FLUCTUATED MORE AFTER THE VACCINE AND GONE UP. THIS IN TURN IS STRESSFULL AND AFTER THE VACCINE I HAD 3 WEEKS OF HIGHER THAN NORMAL BP AND PANIC ATTACKS OR HIGH ANXIETY WHICH I HAD NOT EXPERIENCED BEFORE THE VACCINE. OTHER THAN THIS FRIGHTENING REACTION THE LESSER SYMPTOMS WERE: TIRED, HEADACH, LOW ENERGY, FEELING OF BEING ILL -- NO FEVER. I TOOK SHOWERS TO CALM MYSELF. I DO NOT BELEIVE AT PRESENT THAT ANXIETY CAUSED THE REACTIVITY -- RATHER THAT THE VACCINE CASUED THE ANXIETY. THERE WAS AND IN SMALL ORDER -- STILL IS -- A SENSE OF BEING REVED UP -- AFTER THE VACCINE. AND I AM VERY SCARD OF TAKING THE NEXT DOSE. IN ADDITION, MY DOCTOR OF 25 YEARS WAS TAKEN OUT OF THE NETWORK OF MY INSURANCE PANEL AND HE WAS A GREAT DIAGNOSTITION WHO RESEARCED EVERYTHING THOROUGHLY --- I DO NOT HAVE A PROPER DOCTOR AT THIS TIME. I WOULD REALLY LIKE TO CONSULT WITH A SPECIFIC DOCTOR.
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| 64 | 2021-04-09 | anxiety |
One hour after injection redness severe inflammation pain hot to touch - treated with cold ice pack ...
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One hour after injection redness severe inflammation pain hot to touch - treated with cold ice pack (no towel) - broke out with blisters after applying ice pack - went to ER applied bacitracin ointment - followup with M.D. - burst blisters - treated for 3d degree burn with burn ointment and wound care - took pictures thru process
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| 64 | 2021-04-09 | feeling abnormal, loss of personal independence in daily activities, confusional state |
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain...
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feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.
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| 64 | 2021-04-09 | sleep disorder |
Tinnitus, humming like a fan or motor in Left ear. Ongoing, constant. Seems worse as the day progr...
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Tinnitus, humming like a fan or motor in Left ear. Ongoing, constant. Seems worse as the day progresses. Also waking in the night and wide awake, which isn't normal.
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| 64 | 2021-04-11 | feeling abnormal |
Patient called in to triage stating that the night after she received the second dose of the Pfizer ...
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Patient called in to triage stating that the night after she received the second dose of the Pfizer COVID19 vaccine. She reports feeling nauseated. Friday 4/9/21 and Saturday 4/10/21 She reports brain fog. At times she feels unbalanced and does not feel well enough to drive. She felt very weak "lack of muscle control manifested as muscle weakness. She stated "the weakness is in the middle of the night". "Lose control of my muscles in the legs". Fell asleep on the floor as she is too tired to walk to bed this has happened 6 times in the past 4 months. Last 2 times were after the COVID19 vaccine Alert and aware of her surroundings but feeling weak. She reports this happens the night before she "gets covid19". She reported she is a "COVID19 Long Hauler" She stated she is still "lethargic and weak" since getting the shot. Since getting COVID 19 Vaccine no shivering and no fever.
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| 64 | 2021-04-12 | feeling abnormal |
10 minutes after shot I got very hot and tingly and felt out of sorts for 5 minutes,do have history ...
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10 minutes after shot I got very hot and tingly and felt out of sorts for 5 minutes,do have history with anaphylactic shock during chemo infusions 10 years ago
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| 64 | 2021-04-13 | abnormal dreams |
Temperature: 3 degrees above my normal on 4/11 and it has gone down and up since without ever retur...
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Temperature: 3 degrees above my normal on 4/11 and it has gone down and up since without ever returning to my normal temperature. Achiness starting 4/11 throughout body which still continues to today (4/14). Intermittent headache from 4/11 to present. Stomach distress since 4/12 with cramping and abdominal pressure. Occasional diarrhea with one pound loss daily since 4/10. Decreased appetite. Constant tiredness. I continue to drink ample fluids. I have had nothing except disturbing dreams since the vaccination.
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| 64 | 2021-04-13 | disturbance in attention, sleep disorder, loss of personal independence in daily activities |
Acute headaches, chills, tight chest pain, fever With in a few hours after receiving the vaccine. D...
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Acute headaches, chills, tight chest pain, fever With in a few hours after receiving the vaccine. Dealing with headaches for 6 days, making difficult to rest at night and concentrate.
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| 64 | 2021-04-13 | sleep disorder |
Woke up ion middle of night. Wet with sweat. No fever. Have felt bad since. Feel like I have a press...
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Woke up ion middle of night. Wet with sweat. No fever. Have felt bad since. Feel like I have a pressure in top of my head. No headache . Feel like I have a band around my head
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| 64 | 2021-04-14 | impaired work ability |
Started experiencing fatigue the next day. Had to leave work early, , had nausea, chills, fever, j...
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Started experiencing fatigue the next day. Had to leave work early, , had nausea, chills, fever, joint pain, headache. Slept for 19 hours. Headache continues into following day, but fever gone, still fatigued.
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| 64 | 2021-04-14 | loss of personal independence in daily activities, insomnia, abnormal dreams, disturbance in attention |
7 pm feeling of tiredness so I lay on sofa 11 pm when I got up to go to bed, splitting headache, pr...
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7 pm feeling of tiredness so I lay on sofa 11 pm when I got up to go to bed, splitting headache, pressure behind both eyes, chills, fever 100.3, delirious dreams at night, not much sleep, fatigue 10 am Thur morning feeling of weakness, could not take a shower, could not concentrate, went to lay on sofa 12 noon made 2 eggs and lost energy again, back on sofa 11 pm went to bed, could not sleep, extreme pain in back (from laying down 28 hours?) walked around, drank water, took 2 tylenol
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| 64 | 2021-04-14 | sleep disorder |
At approx 8:30pm on the 13th I started to have stomach/intestinal pain and I thought I was having ...
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At approx 8:30pm on the 13th I started to have stomach/intestinal pain and I thought I was having a bout of Diverticulitis. It was very severe, and included nausea and frequent trips to the bathroom. I was up all night in pain, which finally seemed to be getting better after 8 am. At approximately 10am on the 14th I realized I was coming down with a fever......my temperature was 100.2 I had a temperature of 100.2 until at least midnight. I woke up at 6 am on the 15th with a normal temperature. I am feeling better now, but I put myself on a clear liquid diet. I have no energy and I plan to take it easy for a couple of days.
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| 64 | 2021-04-15 | feeling abnormal |
On set March 6th, 2021: brain fog, fatigue, mild body aches. Took celebrex, 100 mg twice a day. Had ...
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On set March 6th, 2021: brain fog, fatigue, mild body aches. Took celebrex, 100 mg twice a day. Had to stop exercise routine. Side effects decreased after three and a half weeks. Side effects reappeared after odd gastrointestinal issue with chills. Side effects currently present.
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| 64 | 2021-04-15 | sleep disorder |
About 3 hours after receiving injection I noticed swelling around the injection site as well as tend...
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About 3 hours after receiving injection I noticed swelling around the injection site as well as tenderness. Over the next few hours the tenderness became increasingly painful radiating between my shoulders to my elbow as well as numbness to my nose and cheeks. I also experienced fatigue. The pain in my arm interrupted my normal sleeping routine for a couple of nights. As of 04/16/2021 the swelling and pain in my arm has diminished to the point of being normal.
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| 64 | 2021-04-15 | sleep disorder |
First dose on 3/5/21 in left arm - muscle tenderness & some fatigue. Second dose given on 3/26/21...
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First dose on 3/5/21 in left arm - muscle tenderness & some fatigue. Second dose given on 3/26/21 in left arm. Some tenderness in left upper arm. About a week later (April 1) I had left upper back & chest pain (just left of thoracic spine area and forward to left of my sternum bone & left shoulder pain). The area of discomfort increased to under my left armpit. I used Tylenol every 4 hours but still had some pain. The pain was bad enough that I had trouble sleeping at night and reaching for objects in my home. I noticed an "engorged" feeling & tenderness in my left breast. Swollen lymph nodes were present under my left arm - breast was too tender to check for more lymph nodes. No fever. Wasn't sure if I should go to an ER so checked the internet & 4/14/21 Contacted & consulted with my family doctor (Dr - My Chart messages) to let her know. Found information on Web (internet) that some women are having this kind of reaction in lymph nodes so was less worried about something more serious like a heart attack). Afternoon of 4/15 and today 4/16 feel the symptoms are beginning to go away - pain in my axilla area is better, lymph nodes not as hard & tender, left breast and left side of backbone have decreased discomfort.
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| 64 | 2021-04-17 | feeling abnormal |
This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 06Apr2021 13:00 at single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 06APR2021 at around 1PM. She woke up in the middle of night (she usually does so). When she woke up this morning and had a cup of tea, noticed that she was "somewhat sensitive to caffeine" which is unusual because she liked drinking coffee. On 07APR2021, her heart rate (HR) is 96 beats per minute (BPM), which is high because her usual HR is 60 BPM. Her oxygen levels are normal (98%). She asked about this possible side effect to the vaccine, aside from her sore arm. She asked if she could take Ibuprofen. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021389552 Same reporter/drug/AE, different patient
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| 64 | 2021-04-17 | feeling abnormal |
heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe ...
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heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours; body feels like hit with mac truck; tired; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm at age 64 years, on 29Mar2021 14:25 (Batch/Lot Number: ER8732) as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation as a pre-existing condition that normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most and overweight from unspecified date but working on it. Only she has heart history in her family. The patient's concomitant medications was none. Patient historically took first dose of BNT162B2 (Lot: EN6199) with anatomical Location of left arm on 08Mar2021 around 1300 for COVID-19 immunization and flu vaccine received back in 2020 for immunisation. Patient reported that she had the second dose of the Pfizer COVID Vaccine on Monday, 29Mar2021 and three hours later, her heart started fibrillating for 36 hours. She has a pre-existing condition of atrial fibrillation and normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours. Patient contacted the doctor right away via phone. Her doctor, an electrophysiologist, stated not to eat or drink anything after midnight and of patient was still in atrial fibrillation in the morning they would have to perform a cardioversion, with the paddles. Doctor believed this could happen and said its a delicate balance when you put anything else into the system that it could affect persons. On 31Mar2021 at 05:15 that morning, the patient went out of atrial fibrillation and back into normal sinus rhythm. Patient only called the doctor and would have had to go in today if the fibrillation did not stop. Patient also stated that well, it was not a good thing to fibrillate for that long, with due time it can cause congestive heart failure and stated its dangerous. Patient was resting at the time of report and was relieved she is not fibrillating anymore. Patient reported that her body feels like it was hit with a mac truck on Mar2021. Heart fibrillating for 36 hours makes you really tired. The outcome of the event 'heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours' was recovered on 31Mar2021 at 05:15 in the morning, while for the rest of the events it was unknown. Follow-up attempts are completed. No further information is expected.
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| 64 | 2021-04-17 | insomnia |
woke up at 0100; Chills; fever in the night (temperature of 101.2); Headachy feeling like the flu; C...
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woke up at 0100; Chills; fever in the night (temperature of 101.2); Headachy feeling like the flu; Congestion and draining; Very tired; headaches; This is a spontaneous report received from a contactable consumer reported for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 27Mar2021 13:45 as single dose for covid-19 immunisation. Medical history and concomitant medications were none. The patient did not receive additional Vaccines on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was No. AE(s) following prior vaccinations included Whenever caller has gotten the flu vaccine sometimes she feels like she gets the flu. Has had chills, fever and flu like symptoms after receiving flu vaccine. But the last time she received the flu vaccine she did not have any adverse events and was fine. Caller does not have NDC/lot/Exp for the flu vaccine that caused flu like symptoms. The patient reported that today (01Apr2021) she was experiencing some side effects. Reports she thinks she is experiencing side effects but is not sure. She has been having headaches on 27Mar2021 since received the first dose of BNT162B2. The headaches are controlled with Tylenol and it takes them away. Everyday she has had a headache. Caller reported the headaches are just persistent, not turning into a migraine or anything like that. Her headaches are all controlled by taking Tylenol. Caller reports she usually does not get headaches. Taking Tylenol every day is kind of weird, why is she having so many headaches? Taking the Tylenol everyday is helping, but reports constant headache. She has been very tired and very drained on 28Mar2021. Caller was just thinking the other day why is she so tired? Congestion and draining going on also, not quite sure if she has a sinus infection maybe and got the fever because of that. She is trying to figure it all out. Began after receiving the Pfizer Covid Vaccine, wouldn't say it started the same day, it was the following day it started. The site where she received the Pfizer Covid Vaccine was good the next day, not a problem. Reports chills yesterday (31Mar2021), fever in the night. Still having chills today but no fever. Chills began around 1900 at night. Caller didn't feel that great and woke up at 0100, had a temperature of 101.2 (on 01Apr2021) and took Tylenol. The fever broke around 0500 and the fever has not come back. Reports still having chills and headache, headachy feeling like the flu. Almost feels like caller has the flu. Caller would like to know if some of the side effects can show up five days later after receiving Pfizer Covid Vaccine? She has an appointment scheduled Today, 01Apr2021 to go have a Covid Rapid test, wants to make sure she doesn't have Covid. The outcome of fever was recovered. The outcome of headaches, very tired and very drained, chills, and Headachy feeling like the flu was not recovered. The outcome of others was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 64 | 2021-04-18 | disorientation, feeling abnormal |
Arm pain , swelling, hardness Felt cold all night Upon rising, sudden and severe diaphoresis, wave ...
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Arm pain , swelling, hardness Felt cold all night Upon rising, sudden and severe diaphoresis, wave of nausea (without vomiting), passed out cold onto bathroom floor. Woke up disoriented sometime later (Time out?) Felt "off" all day with a headache in the back of my head Went to bed early Friday night due to feeling tired felt relatively normal by saturday afternoon. (Vaccine was Th. morning)
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| 64 | 2021-04-18 | memory impairment |
Passed out on Monday hit head and got a concussion.Went to ER had . Headaches caused by optical and ...
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Passed out on Monday hit head and got a concussion.Went to ER had . Headaches caused by optical and vestibular systems does to hitting head. Bump on right side of head that continues to hurt.Balance is off due to vestibular. Some short term memory issues.OT and PT.
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| 64 | 2021-04-20 | restlessness, sleep disorder, feeling abnormal |
had chills after shot and all night, very very tired, but not sleepy, couldnt sleep, next morning fe...
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had chills after shot and all night, very very tired, but not sleepy, couldnt sleep, next morning felt terrible throughout day felt dizzy, chills, upset stomach, headache, shot arm hurt to move and felt very heavy. very .very very tired again. couldnt sleep, restless again., not very hungry. third day still some symptoms especially very tired, but not sleepy. next day just still very tired
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| 64 | 2021-04-20 | sensation of foreign body |
Patient reports lightheadedness, burning and lump in throat. Benadryl given. symptoms improved by...
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Patient reports lightheadedness, burning and lump in throat. Benadryl given. symptoms improved by 2:51pm.
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| 64 | 2021-04-21 | amnesia, confusional state | Confusion and memory loss. Lasted about a week. Very obvious to me and to those around me. |
| 64 | 2021-04-21 | nervousness |
3/12/2021 first dose Pfizer vaccine 20 min lightheaded [describes as though she wasn?t completely p...
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3/12/2021 first dose Pfizer vaccine 20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx. Subsequent severe fatigue, slept for 4 hours. During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea. Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness. Back to baseline in 4-5 days
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| 64 | 2021-04-21 | sleep disorder, memory impairment, feeling abnormal |
Pain occurred at the time of the injection (this did not happen with first vaccination). A knot at i...
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Pain occurred at the time of the injection (this did not happen with first vaccination). A knot at injection site about the size of a sweet pea. The site is warm to the touch and very itchy. I feel out-of-sorts. Kind of tired and listless. I did not sleep at all last night (4/21pm-4/22am). My stomach is slightly upset. No vomiting at this point. My temp is 99.0 f. I am suddenly forgetting words. The word I heard or thought about a few minutes or seconds ago is just gone. Completely. This is unusual for me and is VERY concerning.
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| 64 | 2021-04-22 | loss of personal independence in daily activities, feeling abnormal |
Throbbing pain within 5 min. Swelling within 1 1/2 hours, Rash on left arm the next morning. Lots o...
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Throbbing pain within 5 min. Swelling within 1 1/2 hours, Rash on left arm the next morning. Lots of discomfort on left arm and left side that first night. Arm was swollen over double. Lymp nodes swelled and no voice. DId not move arm. Rash on upper body that first 2 weeks. The rash on the left arm continued the first 4 weeks. Very swollen...HOT to touch...looked like alligator skin and raised. Now it comes for 2 days and goes down for a few days. Get mentally foggy unless I take an allergy medication 3-4 times a day. Advil every 4 hours for joint pain...it has been miserable! Swelling in joints on upper body. EXHAUSTED. Thryoid was normal prior to the vaccination and has double-now on Thryoid Medication.
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| 64 | 2021-04-23 | impaired work ability |
Pain from injection site to tips of my fingers for over 40 days now. Unable to perform my profession...
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Pain from injection site to tips of my fingers for over 40 days now. Unable to perform my profession of jewelry designer.
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| 64 | 2021-04-23 | insomnia |
Dizziness and weakness immediately upon standing up from the chair. I didn't think much of it at the...
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Dizziness and weakness immediately upon standing up from the chair. I didn't think much of it at the time because I often get light-headed with needles. And the room was stuffy, alcohol scent. After the 15 minutes, I drove home. During the drive home I started to think I wanted to be in bed. I got home, was hungry, ate lunch, and went to bed. I got up around 5, still feeling weak but not tired. I went to bed again at my normal bed time but did not sleep well. In the morning I still felt weak, but was fine by early afternoon. Then the next day in the afternoon I got a pinpoint headache in the back right of my head. Also started feeling weak again. Today the headache is still there but not localized. Still feel weak.
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| 64 | 2021-04-24 | anxiety |
Rapid pulse causing my blood pressure to drop and cause me to be weak and shaky/ rapid heartrate; Ra...
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Rapid pulse causing my blood pressure to drop and cause me to be weak and shaky/ rapid heartrate; Rapid pulse causing my blood pressure to drop and cause me to be weak and shaky; Rapid pulse causing my blood pressure to drop and cause me to be weak and shaky; Rapid pulse causing my blood pressure to drop and cause me to be weak and shaky/a little shaky; anxiety; My blood pressure went higher/ the blood pressure shot up to 135; My pulse went down; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in Left Arm on 22Mar2021 (at the age of 64-year-old) at single dose for so she didn't get hospitalized or die from Covid. Medical history included anxiety. The patient's concomitant medications were not reported. Other Products reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect were none. No prior vaccinations (within 4 weeks). Patient reported that she had her first dose of the vaccine 3 1/2 weeks before. She postposed the second dose because she experienced a rapid pulse causing her blood pressure to drop and cause her to be weak and shaky. Then her pulse went down and her blood pressure went higher in 2021. She reported that she did not need to receive treatment for the symptoms she experienced but rapid heartrate was listed as a severe side effect and she was nervous about getting the second reporting that her understanding was that side effects from the second dose could be more noticeable with the second. She had been her General Practitioner and her Cardiologist and neither of them know what she should do. She had a side effect after the first dose of the vaccine. On an information handout she read under severe reaction that it mentioned rapid heart beat. About 1 and 1/2 to 2 hours after the injection on 22Mar2021, she had a rapid heart beat and her pulse went down. She felt kind of off and a little shaky. She had postponed her 2nd dose until she received clarification on what she read. She was tentatively scheduled for 12Apr2021, but would reschedule if needed. Caller clarified that she had rapid heart beat and drop in blood pressure one and a half to two hours after the injection on 22Mar2021. She took her blood pressure on her home cuff. She was 64 and not super physically fit, but her pulse tended to run around on average from 60-65 on an unspecified date. Her blood pressure went down and pulse went up on 22Mar2021. She thought it could have been her anxiety or something on 22Mar2021. Her numbers all came back after a period of 30 to 60 minutes. She had never had her numbers go in that direction with anxiety. She had never had her blood pressure drop with raised pulse and vice versa. When the pulse came down the blood pressure shot up to 135 in 2021. She had relatively good blood pressure for a person her age. She usually runs around 100 to 120 on the top number on an unspecified date. Vaccine information card was difficult to read by reporter. Patient clarified LOT number as EN6205, but said it was difficult to read what was handwritten. She was on her way to see her Cardiologist today because her Primary Care Provider could not address her issue. Everything she had read about the 2nd dose indicated a more severe reaction and that was why she needed to be checked out and her experience addressed. No treatment was received for all events. The outcome of the events rapid pulse, blood pressure drop, weak and shaky was recovered on 22Mar2021; outcome of the other events was unknown. This report was reported as non-serious. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-24 | feeling abnormal, memory impairment |
passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head seve...
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passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
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| 64 | 2021-04-24 | feeling abnormal |
I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hea...
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I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hear it, could felt it in my chest. Then trembling; heart palpitations and it was skipping and trembling off and on; arm is sore; weird feeling; trembling; trembling, shaking and she thought she was going to have a seizure, she had no control over her muscles; muscles twitching, like if I had no control over the muscles; she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot; didn't feel good last night; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 64 years old. Medical history included cholesterol (abnormal, takes cholesterol medication 3 times a week as she gets side effects from it), cutaneous lupus (She always has to do bloodwork and goes in every 3 months), heart problem that is not major (she takes 1 medication, patient stated once in a while she sees her cardiologist every 6 months and she did get a halter monitor for 24 hours for a week and they take an average and said it wasn't as bad and knows that is a problem), 2 cervical spine surgeries, arthritis, allergic to contrast dye for CAT scans, allergy to medications (sensitive to medications), shrunk a lot because of issues, and had surgery which shrunk her because of her spine from an unknown date. Concomitant medication included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal from 2016 and ongoing; and nadolol (CORGARD) taken for an unspecified indication from 2001 and ongoing. Patient's son got COVID on an unspecified date. Patient previously took generic atorvastatin which made her sick on an unspecified date and LIPITOR and experienced muscle weakness on an unspecified date. No additional vaccines administered on the same date of the Pfizer vaccine. No prior vaccinations. Patient never got a flu shot as she was scared. On 06Apr2021, her arm was sore which is normal. Normal side effects from the arm did not concern her, patient had no fever nothing else. She stated she came home and felt like she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot and she made sure of that. At 19:00 (also reported as 7-8pm), patient experienced her heart was skipping really bad. Patient could hear it and could felt it in her chest. Patient clarified her heart was not fast, it was more skipping, and she could feel it beating in her throat. She commented has a problem but that has not happened in a long time. Patient then experienced trembling described as lots of body trembling concerned like a seizure. She thought she was going to have a seizure. It was not chills; she had no fever or anything. The trembling came on and off. Her muscles were twitching, like if patient had no control over the muscles. Patient did not feel dizzy, it was a weird feeling. She did not feel good. On 07Apr2021 at 02:00, patient felt very tired and weak, her heart was better. About 02:00 she fell asleep. She woke up at 6:30 and she felt tired but that does not bother her. Her concern was the body trembling. She called her doctor but was not available. She was advised that it does not sound like a symptom of the vaccine. She was worried she needs to go to the cardiologist and see what is happening. She stated if it keeps happening, she will go, and she does not know if this is a side effect other people are reporting. Patient was wondering if this is a reaction as she cannot find it, one says a severe reaction is a fast heartbeat, really fast and skipping and she does not know. She expected anything, tired, headache, muscle aches but these did not happen, but she was expecting them to. Patient is wondering why her heart is doing that is it from the shot or what is going on with her which is weird, and stated the shaking, trembling of her whole body is weird. She mentioned she is sensitive to medication and gets reactions to a lot of medications. She stated this is why she was scared to get the vaccine and what the reaction was with the 1st. Patient stated her heart is a lot better than it was last night, that she feels very tired and feels unwell. She stated she took her temperature (Apr2021) and she had no fever, no nothing a little unwell, a weird feeling. Patient stated she is not trembling anymore and has no heart skipping, that went away about 2am when she fell asleep for a few hours (also reported as went away after about an hour, she had it off and on 3-4 times in an hour). Patient clarified she has not had testing done for the reported symptoms. The patient stated she is concerned and does not know what to do about second dose, which is scheduled for 04May2021. She does not if it was a reaction and stated she is very sensitive to medicine. Events did not require emergency room and physician office visit. Outcome of the event heart was skipping, tremor and palpitations was recovered on 07Apr2021 02:00 while unknown for the other events. Follow-up attempts are completed. No further information is expected. Lot number has been obtained.
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| 64 | 2021-04-24 | feeling abnormal |
she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness...
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she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1 via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-24 | feeling abnormal |
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las...
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Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
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| 64 | 2021-04-24 | nervousness, feeling abnormal |
left arm sore/ left neck and arm were sore; left side of her neck was very sore/ left neck and arm w...
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left arm sore/ left neck and arm were sore; left side of her neck was very sore/ left neck and arm were sore; left arm, leg and especially left foot were numb; like when you are shaky and hold out your hand and the shaking felt like shaking inside; it was a strange sensation; This is a spontaneous report from a contactable nurse reported for self. This 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6206) in her left upper arm on 18Mar2021 10:10 at single dose for COVID-19 immunisation. Medical history included ongoing mild asthma (diagnosed a long time ago and it was allergy or exercise triggered, that it was not debilitating). Concomitant medications included amlodipine from Jul2020 and ongoing. The patient previously got the influenza vaccine (FLU) shot for immunisation, and experienced her arm would be numb and sometimes she felt a little tired and achy for a day. Patient stated she was trying desperately to see if she should get the 2nd shot as she had a strange reaction and no one was able to help her. She stated it was a strange reaction that started the same day she got the vaccine on 18Mar2021 about 6 hours after the vaccine. Stated she did take a nap and the reaction may have started in her sleep but she noticed it when she woke up which was 6 hours after the shot. She clarified the strange reaction as being her left arm sore and she expected that and the left side of her neck was very sore, her left arm, leg and especially left foot were numb. Stated it felt like, it's hard to describe, like when you are shaky and hold out your hand and the shaking felt like shaking inside and it was a strange sensation. She stated the next day her left neck and arm were sore. The numbness was just her left hand and left foot and resolved to an intermittent, by 24Mar2021 it was intermittent and by 01Apr2021 that had resolved but she still had some numbness in her left foot if she stand a long time like if she was cooking. She stated these were all new to her and had never happened before and can only thought it was the vaccine by the way it presented. Events did not require a visit to Emergency Room or Physician Office. The outcome of events was unknown. The events seriousness was not reported, causality assessment from the reporter was related. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-24 | nervousness |
Temperature rises and goes down; Shortness of breath; It seems like she's getting hot like she's per...
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Temperature rises and goes down; Shortness of breath; It seems like she's getting hot like she's perspiring; Itchiness; Pain in the joints toes elbow hips not consistent in one place; Chills; Persistent headache; Tiredness/fatigue; nervous; Nausea - very mild; capillaries burst in her left arm; Bruises in left arm; hematoma; This is a spontaneous report received from a contactable other health care professional reported for self. A 64-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine) via an unknown route of administration in upper right arm on 24Mar2021 11:15 (Lot number ER8732) at single dose for COVID-19 immunisation. The patient medical history included emphysema diagnosed between 2003-2005 and unknown if ongoing or stopped, lung disease, previous smoker and ongoing perspiration. The patient stated she felt like she was high risk for COVID-19 due to their age and she had emphysema, for which she received the PFIZER-BIONTECH COVID-19 vaccine. The patient stated she had been in quarantine since Jan2020. The patient concomitant medications included vitamins about a month ago (Mar2021) and stopped. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient experienced headache on 24Mar2021, fatigue and tiredness from 24Mar2021, nausea on 24Mar2021, chills on 25Mar2021, joint pain on 25Mar2021, itchiness on 26Mar2021, seems like she was getting hot like she was perspiring on 27Mar2021, capillaries burst on the left arm in Mar2021, bruise on top and bottom of the left arm, top of the wrist and underneath the wrist in Mar2021. The patient received the vaccine on 24Mar2021 and was still dealing with some symptoms. The patient stated the headache is unusual. It hurts on her forehead or sides of the head. Sometimes the pain is more severe and sometimes it's dull. It last for about 20-30 minutes. It comes and goes. The patient explained that fatigue and tiredness different for her. The patient said that she was very tired that same day as the vaccine. She said that she and her husband had the same symptoms and they were both very tired. She said that they were extremely tired for 2 days, especially him, and they did not get out of bed. The patient stated she and her husband had the appointment at 11 am and by 12:30pm to 1:00 pm they were already in bed and both fell asleep super fast; within 3 hours. She felt fatigued, but not as exhausted as the first two days. On 05Apr2021, she could be only be in the garden for 2 hours, and then went inside to shower and went to bed. She said that she is currently in bed. Her husband is up walking about. Fatigue is when she can't do anything. The patient had been nauseous. Her nausea was mild and lasted 5-10 min after the vaccine, it was very mild and thought she was just nervous and that she needed to eat. The patient felt chills once or twice a day and lasts for seconded. Chills started in the morning on 25Mar2021. It happens like once or twice a day, just for a few seconds. She states it doesn't feel like a usual chill. She said that it did not feel like a chill that you get when you have a cold or something. It's odd because she has no sensation, but all of hair stands up on end and she feels odd. She adds It's not like when you have a fever. She said that it is very strange. She stated she didn't think she had a fever, but feels like her temperature goes up. Temperature rises and goes down. This lasted for ten seconds at most. The patient stated the joint pain is in her elbow, on 05Apr2021 it was in her toes, then in her hip. It is not in the same place, not consistent in one place, and it's milder but not gone. The patient said that she will seem like she is very hot and she will start perspiring and then she will stop. It is on and off. She also experienced perspiration before and after the vaccine. In the past, she never experienced feeling warm like that, and it doesn't last long, it seems like her body temperature is higher. It seems like she's getting hot like she's perspiring, but she does not have a thermometer to check her temperature. She also had itchiness that started 2 days after the vaccine 26Mar2021. It is mild now, but it was more severe. The patient added that her capillaries burst in her left arm 3-4 days after the vaccine, but started to heal on the same day. On the left arm on the top of the vein, she has black and blue bruises. There is one on top of wrist and underneath the wrist. The bruise is on the top and bottom of the arm and it follows the little veins. The bruise turned red and purple and became a hematoma, but it's clearing now. She's not sure if she has lasting effects, it's still visible but very faded. It doesn't hurt, but the top of the wrist is still very dark. Underneath the wrist has faded. It looks like she has bruises. The patient also had shortness of breath on an unspecified date. She used to be a smoker. This was sometime between 2003-2005. She has corrected that behavior and feels like she's in good health. She was not aware of the condition in the past. Her air exchange is good and she exercises. She had no problem with shortness of breath in the past. The patient did not treat her symptoms. None relevant tests. The patient is scheduled for the second dose on the 14Apr2021, but is concerned due to these symptoms. The patient was asking if she can safely have the second dose since she has been experiencing some of the symptoms for 14 days now. The outcome of the events itchiness, nausea was resolving. The outcome of the event hematoma was resolved. The outcome of other events Chills, headache, Tiredness/fatigue, Pain in joint, getting hot was not resolved. The outcome of the other events was not provided. No follow-up attempts are possible. No further information is expected.
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| 64 | 2021-04-25 | memory impairment, nervousness |
Patient states 3 minutes after receiving the vaccine felt head to toe sensation of "blood rushed out...
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Patient states 3 minutes after receiving the vaccine felt head to toe sensation of "blood rushed out of my body." Felt "nervy and tingling". States heart rate was 100 and was told she was pale. 2-3 days post vaccine developed severe left ear preauricular pain. Now continues to feel vertigo, lightheadedness, dizzy, on and off palpitations, fatigue, "nervy tingly" and some changes in short term memory.
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| 64 | 2021-04-26 | crying |
Acute onset of unspeakable back pain 10/10; Unable to move without screaming and crying; Unable to m...
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Acute onset of unspeakable back pain 10/10; Unable to move without screaming and crying; Unable to move without screaming and crying; Unable to move without screaming and crying; Lost 7.8 lbs in 6 days; This is a spontaneous report from a contactable physician. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (received at 64-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included refractory lymphocytic microcolitis. The patient was not pregnant. She had no COVID prior to vaccination. Concomitant medication(s) included budesonide (BUDESONIDE) taken for an unspecified indication from 01Apr2021 to an unspecified stop date; vedolizumab (ENTYVIO) taken for an unspecified indication from 09Mar2021 to an unspecified stop date. The patient previously took diflucan, nitrofurantoin, flagyl [metronidazole] and experienced allergies (known allergies). On 05Apr2021 06:00 AM, the patient had an acute onset of unspeakable back pain 10/10. She was unable to move without screaming and crying. The patient received Flexeril and was hospitalized 5 days. The patient underwent laboratory test and procedures which included: CRP (C-reactive protein) =170, Sedimentation rate=34. She had no cardio or pulmonary issues. She lost 7.8 lbs in 6 days (weight 103). It was reported that all adverse events occurred on 05Apr2021 06:00 AM. The patient was tested for COVID post vaccination via nasal swab on 02Apr2021 and 07Apr2021 with results of negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient received corrective treatment in response to the adverse events, which included Dilaudid and Valium and hold still in bed. Outcome of the events was recovering.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 64 | 2021-04-26 | excessive sleepiness |
After getting the first shot, I was very tired, I slept for 17 hours waking once after 9 hours for b...
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After getting the first shot, I was very tired, I slept for 17 hours waking once after 9 hours for bathroom. The next day under my left arm was sore for several days. After the second shot on 4/17/21, I was tired. Under my left arm I had a large mass (swelling) that was very painful. The swelling lasted for three days. Now (4/25/21) I have pain under my right arm. Presently I do not see any swelling or feel anything , just pain.
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| 64 | 2021-04-26 | excessive sleepiness |
I went to bed a healthy person and did not wake up until Sunday Afternoon. I ached everywhere, could...
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I went to bed a healthy person and did not wake up until Sunday Afternoon. I ached everywhere, couldn?t stay awake had fever and a cough that felt like my head was going to blow off if I didn?t hold it. I had a slight UTI Friday which I was going to treat over counter but when I woke up I had a full blown UTI with blood In my urine. Went back to health dept. Tuesday and was given a COVID test which I did. Wednesday I was getting worse and went to walk-in clinic and was given two shorts antibiotics and cough syrup . Sill not well Monday went back to walk in clinic got two more shots and more medicine and cough syrup.
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| 64 | 2021-04-27 | feeling abnormal, sleep disorder |
Sharp pain in elbow, forearm, and wrist of right arm, usually resulting in trouble sleeping due to t...
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Sharp pain in elbow, forearm, and wrist of right arm, usually resulting in trouble sleeping due to the pain Foggy brain even when getting getting sufficient sleep Fatigue even when getting sufficient sleep
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| 64 | 2021-04-27 | insomnia |
Headache, beginning on 4-21 Sleeplessness, beginning on 4-21 Abdominal pain and generalized weakness...
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Headache, beginning on 4-21 Sleeplessness, beginning on 4-21 Abdominal pain and generalized weakness, beginning on 4-21 Higher than normal blood pressure 189/91 in ER Went to the ER on Wed. 4-21, and Friday, 4-23. Went to see PCP, on Monday, 4-26. Chills-- No fever on 4-28-2021. Shortness of breath Pressure on upper back, with weakness of both legs
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| 64 | 2021-04-27 | panic reaction, abnormal behaviour, confusional state, restlessness, delirium, excessive sleepiness, memory impairment |
? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient ...
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? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .
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| 64 | 2021-04-28 | disturbance in attention, loss of personal independence in daily activities |
Extremely tired Lack of energy Just Walking across the floor seems like it takes forever I notice...
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Extremely tired Lack of energy Just Walking across the floor seems like it takes forever I noticed my gait is even more stiff... I feel like I?m 200 years old I can?t do activities for very long until I have to lay down I feel I can?t clear my mind Not able to process things as I used to do so I get very little done or accomplished In the morning my head hurts I feel like I have a hang over all the time
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| 64 | 2021-04-29 | disturbance in attention |
I GOT RINGING EARS WITH THE FRIST DOES. A FEW DAYS AFTER GETTING IT. IT HAD BEEN 24/7 . IAM HAVING T...
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I GOT RINGING EARS WITH THE FRIST DOES. A FEW DAYS AFTER GETTING IT. IT HAD BEEN 24/7 . IAM HAVING TROUBLE SLEEPING. THE NOISE IS CONTANT. IT HAS GOTTON VERY LOUD AT TIMES<I CANT CONSETRATE BECAUSE THE RINGING NEVER STOPS. I GOT THE SECOND DOES 1 MONTH LATER <THE ONLY SIDE EFFECT WAS A SORE ARM> IT WENT AWAY IN A FEW DAYS>
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| 64 | 2021-04-29 | impaired work ability |
1 1/2 weeks post dose 1, 4/13, I started to have lo grade fever, headache, muscle weakness and body ...
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1 1/2 weeks post dose 1, 4/13, I started to have lo grade fever, headache, muscle weakness and body aches. On 4/15 I broke out in a red splotchy rash all over my arms, then my front torso and back torso. I had blood work on 4/17 and my kidney and liver numbers were very elevated, my platelets were very low, and my red blood cells were described as "immature." on 4/19 I repeated the labs and they were worse. My internist referred me stat to a hematology oncologist. On 4/20 I had a series of discreet tests on my blood, and also a bone marrow biopsy. The concern was acute onset leukemia. My tests came back days later ruling out blood cancer, and the doctor says the best guess is an extreme antibody reaction to the vaccine. My rash began to abate around 4/23. It is now Friday 4/30. I have been unable to work, and my symptoms are continued muscle pain and weakness. I still have some lo grade fever, headaches and dry sinuses. I have never felt sick like this.
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| 64 | 2021-04-30 | fear |
she has been having some sore throat or tightness of the throat issues that she felt should be looke...
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she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she feels like her voice is getting either strange or raspy or something and had worsened; events are getting worse/Feels like she is going downhill/debilitating; Discomfort; She is in pain constantly and is scared and had worsened; Burning skin; She is in pain constantly and is scared and had worsened; electrical sensation/electrical sensations on most of the left side of the body and had worsened; severe neurological burning pain and getting worse; She can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 08Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 64 years) for covid-19 immunisation. Patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Feb2021 for covid-19 Immunization Batch/lot number EN9804, as single dose into right arm. Medical history included hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date, skin burning sensation and paraesthesia from an unknown date following unspecified brand shingles vaccine following first dose, Lot/NDC/Expiry: unknown. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication and flecainide acetate (FLECAINIDE ACETATE) taken for an unspecified indication. The patient experienced severe neurological burning pain and getting worse (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she has been having some tightness of the throat issues that she felt should be looked at (medically significant) on an unspecified date with outcome of unknown , she is in pain constantly and is scared and had worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , electrical sensation/electrical sensations on most of the left side of the body and had worsened on 08Mar2021 23:00 with outcome of not recovered , she has been having some sore throat that she felt should be looked at on an unspecified date with outcome of unknown , burning skin on 08Mar2021 23:00 with outcome of not recovered , she feels like her voice is getting either strange or raspy or something and had worsened on an unspecified date with outcome of not recovered , she is in pain constantly and is scared and had worsened on 08Mar2021 23:00 with outcome of not recovered , and discomfort (discomfort) (non-serious) on an unspecified date with outcome of not recovered. The events are getting worse/feels like she is going downhill/debilitating and she is not recovered. She has been trying to get help for these events for about a month, but events are getting worse and no one seems to know what to do. Therapeutic measures were taken as a result of she is in pain constantly. She has seen several doctors and no one can seem to help her. She is trying to get into a neurologist as referred by caller's primary care physician, but the neurologist can't see her for 5 weeks. She was seen in the hospital emergency room last night, 13Apr2021 but not admitted to the hospital. No one there seems to know what to do. ER did some blood work which turned out fine in the hospital and put her on Gabapentin. They told her to take Gabapentin 300mg 3 times daily for 2 weeks. She mentioned that next Tuesday, 20Apr2021 they are sending her in for a thyroid ultrasound but that was at her own request. Blood work done in the hospital on 13Apr2021 came back fine. The patient is not in a study or programme. No additional vaccine was administered on same date of the Pfizer Suspect. She has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-30 | insomnia |
soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has ...
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soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has worsened.; She believed she was injected improperly.; pain and felt that her arm has been "rendered useless".; she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back; difficulty sleeping due to the pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Lot Number: ER2613) (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing obesity. The patient's concomitant medications were not reported. The patient experienced soreness in her left arm for 2 to 3 days (on 20Mar2021) that she thought was going to get better but stated it has worsened. Caller stated that she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back. She reported difficulty sleeping due to the pain and felt that her arm has been "rendered useless". She stated that this has been ongoing for 3 weeks after her first injection. She stated that because of this, she felt like she may need physical therapy in the future. She believed she was injected improperly. She thought that happens more with people overweight, like her, because it is not quite so easy to see the muscle. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and TYLENOL, the patient stopped taking NORCO (she did not like taking it). Despite treatment, it just didn't get any better/did not work and finally she couldn't take it and she ended up going to her doctor, she was told it hasn't been verified it was an injury. The patient outcome of the events was not recovered.
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| 64 | 2021-04-30 | nervousness, sensation of foreign body |
body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart...
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body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer
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| 64 | 2021-05-03 | feeling abnormal, insomnia |
Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotensio...
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Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-05-03 | insomnia, impaired work ability |
EXACERBATION OF MYASTHENIA GRAVIS:DOUBLE VISION, DIFFICULTY SWALLOWING, THROAT CLOSES UP,CHEWING DIF...
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EXACERBATION OF MYASTHENIA GRAVIS:DOUBLE VISION, DIFFICULTY SWALLOWING, THROAT CLOSES UP,CHEWING DIFFICULTY, EXTREME WEAKNESS,BREATHING PROBLEMS DIAPHRAM GETS EXTREMELY WEAK, LEGS GIVE OUT WHILE WALKING, ARMS ARE WEAK, EYELIDS WONT STAY OPEN, CANTS HOLD MY HEAD UP MOST OF THE TIME, SLEEPLESSNESS, THESE SYMTOMS STARTED SLOWLY AND ADVANCED AS TIME WENT ON. I STILL STRUGGLE TO THIS DAY, CANT TAKE CARE OF MYSELF, CANT DRIVE, CAN'T WORK I WAS SENT TO THE EMERGENCY ROOM BY MY DOCTOR, THEY PUT ME IN THE ICU, WAS GIVEN 2 TRATMENTS OF IVIG IT DID NOT HELP. THIS FORM WILL NOT LET ME FILL IN NAME OF HOSPITAL: I WAS IN THE HOSPITAL FOR 3 DAYS. I HAD THIS CONDITION UNDER CONTROL FOR 12 yr
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| 64 | 2021-05-04 | mental status changes |
4/10/21-Patient presented to an outlying hospital ED w/acute N/V/D and abdominal pain. She was found...
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4/10/21-Patient presented to an outlying hospital ED w/acute N/V/D and abdominal pain. She was found to have pancreatitis and was found to be SARS-CoV-2 with screening for admission. She had a history of symptomatic COVID with a positive NP swab 1/2/21. Because the patient had no respiratory symptoms she was considered "asymptomatic." She rapidly progressed to having severe necrotizing pancreatitis. She was transferred to tertiary care center where she remains hospitalized. Her hospitalization has been complicated by acute hypoxic and hypercapnic respiratory failure requiring intubation x 24 hours. She had mental status changes and an MRI revealed posterior reversible encephalopathy syndrome, acute kidney injury, splenic vein thrombosis -parital occlusion.
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| 64 | 2021-05-06 | amnesia, feeling abnormal |
on 5/01/2021 member was with family and reported having a seizure which she does not remember having...
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on 5/01/2021 member was with family and reported having a seizure which she does not remember having, stated she was drinking a Coke and spilled some and the next thing she remembers is being taken to hospital in ambulance, stated had Pfizer first covid shot on 4-12-2021. Stated started getting sick after this shot ?not felt well, didn?t feel like myself, achy, out in left field, had fever the following day after injection, loss of appetite and sense of taste, in a fog and not feeling well,?
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| 64 | 2021-05-06 | anxiety |
right breast pain; Shoulder pain; can't move shoulder/ can't move her arm/ her shoulder is immobile;...
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right breast pain; Shoulder pain; can't move shoulder/ can't move her arm/ her shoulder is immobile; Shortness of breath; Anxiety; breast is hard; shoulder pain was going down her back to the trapezius/ all the way to the back; This is a spontaneous report from a contactable nurse, the patient. This 64-year-old female patient reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: ER8731) via an unspecified route in the left arm on 18Apr2021 at 12:15 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included tick bite, blood pressure, nerve pain, gastroesophageal reflux disease (GERD), and sciatica. The patient had no family history. The patient had no other prior vaccinations (within 4 weeks) of the COVID vaccine. Ongoing concomitant medications included olmesartan for blood pressure, duloxetine for nerve pain, omeprazole for GERD, famotidine for GERD; all taken for years, meloxicam for sciatica taken for 2 months and ongoing and doxycycline from 16Apr2021 and ongoing for tick bite (reported that she kept forgetting to take it). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) on 28Mar2021 at 12:00 in the left arm as a single dose for COVID-19 immunization. That dose went in the deltoid and she had no issues. Then she received the second dose on 18Apr2021 at 12:15 in the left arm. She believes it was administered in the soft tissue behind the deltoid. She noticed the person who gave the injection went behind the muscle toward the back of the arm. The next day after the second dose, she felt fine. Then the second morning it felt as if her shoulder was dislocated; and her breast is hard and painful; and she can't breath. She called her doctor who said that was not a common side effect but she stated she knows it is a side effect. The doctor recommended she go to the ER but patient didn't want to go. She stated that she doesn't know if missing the muscle is going to let the medication absorb or if it has penetrated the soft tissue. The clinical course of events was further described as follows: On 20Apr2021 at 08:00, the second morning, she woke up and felt severe pain in her right breast and shoulder all the way to back; adds she can't move her arm and her breast is so painful she can't touch it and her shoulder is immobile. She is also having very bad shortness of breath, adds she thought that may be from anxiety; so later in the day she took a alprazolam (XANAX). She added that she put up with the pain all morning and thought maybe she was working herself up so she took one half of a Xanax to calm down, to see if it was just anxiety but the shortness of breath and pain were still there. She reported she was continuing to feel all of these effects at the same level. She doesn't want to go to the ER because of the expense. The shoulder pain was going down her back to the trapezius. She clarified that she can move her shoulder and her arm, but the pain was so breathtaking that she doesn't move it and she has her arm in a sling. There were no relevant tests performed. The clinical outcome of the events right breast pain, breast is hard, shoulder pain, shoulder pain going down her back, shortness of breath, can't move shoulder/arm/ shoulder is immobile, and anxiety was not recovered. The patient mentioned that she doesn't know if not getting the shot in the deltoid caused her symptoms or not.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-05-07 | feeling abnormal |
feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous...
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feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.
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| 64 | 2021-05-08 | loss of personal independence in daily activities |
3 days after 1st vaccine experienced excruciating shoulder/elbow joint pain. Unable to comb hair an...
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3 days after 1st vaccine experienced excruciating shoulder/elbow joint pain. Unable to comb hair and much difficulty getting dressed. 2 days after 2nd vaccine experienced severe wrist/finger joint pain. On a scale of 1-10, pain was a 12.
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| 64 | 2021-05-19 | anxiety, thinking abnormal, feeling abnormal, agitation, amnesia, insomnia |
felt achy; does not have the energy; sore inside my mouth; sound can hurt my ears; base of my left t...
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felt achy; does not have the energy; sore inside my mouth; sound can hurt my ears; base of my left thumb hurts underneath the thumb where the thumb attaches to the hand; left hand cramp and tightness; Couldn't talk; could barely open her eyes / not be able to open her eyes; fell to the floor; food can taste extra, extra intense; ALT 71 (normal 7-52); sodium 131 (normal 136-144); MCH 34.20 (normal 26-34); MCV 100.30 (normal 80-98); i have a hard time seeing my computer screen; Headache; back pain; neck pain; shoulder pain; short term memory loss/memory problems; skin hurts; flustered; my body temperature, I can be freezing one minute and so hot; brain fog; can't find the words; I feel like I have ADD but on steroids; worked really hard to keep focus; not feeling well; itchy scalp that would be due to the Shingles; Muscle cramps; Muscle tightness; hard to walk; intense anxiety; big emotions, big anger, really really intense; big emotions, big anger, really really intense; exhausted/ fatigue; shingles; like the flu; staring into space; myoclonic jerks; hard time sleeping; stomach gas and bloating; stomach gas and bloating; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EJ1686), via an unspecified route of administration in the left arm on 17Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing preglaucoma diagnosed 3-4 years ago, ongoing anxiety and depression her whole life, bronchitis at age 5, sinus infections, ongoing sinus allergy "stuff" and allergies (now the patient managed the allergies and did not get sinus infections), "vagititis" over 10 years ago and just essentially being dry, menopause a long time ago, both big toes have some fungus for probably 3 years (toenails look ugly, discolored and thick), ongoing arthritis and bone spurs to C5 and C6 to the area of the neck for which the patient did physical therapy (PT) for about 2 years, low on b-12 when she had shingles last time in 2016, "because I dont want to get Covid" (prophylaxis therapy), nearsighted and wore bifocals. Concomitant medications included bupropion for anxiety and depression for 5 years or longer, loratadine for allergies, COLECALCIFEROL (VITAMIN D3) for depression for 10 (maybe 20) years or more, vitamin b complex (SUPER B COMPLEX) from 2016 and ongoing for "low on B-12", cyanocobalamin (VITAMIN B-12) from 2016 for low B12, latanoprost for preglaucoma, clonazepam from 2012 and ongoing for anxiety, ESTROGENS CONJUGATED (PREMARIN) vaginal cream for "vagititis" and just essentially being dry, ascorbic acid (VITAMIN C) for "because I dont want to get Covid" and an unspecified complete multivitamin for women 50 and older from 2020 "so I wouldn't get Covid". The patient previously got the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK5730) in the left arm on 30Dec2020 (at the age of 64-years-old) for COVID-19 immunization. Around the middle of Feb2021, the patient had a hard time sleeping. She still napped during the day most days. Also around middle of Feb2021, the patient noticed muscle jerks, which came and went. It had gotten worse. The doctor said these were myoclonic jerks. The worst was on 28Mar2021. In the middle of the night, the patient called her on call doctor and asked if it might be a seizure. The physician said it was not a seizure. The weekend of 06Mar2021, the patient started to not feel well. She did not sleep well that Friday or Saturday night. She could not access her memory (short term memory loss) as of 07Mar2021, was flustered and it was clear that something was off as the day progressed. On 07Mar2021, the patient felt her skin hurt, like when you had a fever and the skin hurts. This came and went. Around 07Mar2021, the patient felt intense anxiety which branched out into other intense emotional reactions (big emotions, big anger). On an unspecified date, the patient had a sore inside the mouth. Around 07Mar2021, the patient felt freezing one minute and so hot the next. On 07Mar2021 at 03:00, the patient experienced a bad headache. It was like her neck and her back and her shoulders had intense pain, cramping pain and she had to soak in Epsom salt. The severe headache happened twice, lasted about 2-3 days, moved from the right side of the head, or top of the head. She stayed home from work on 08Mar2021 and 09Mar2021. The patient was exhausted and felt achy, like the flu. She had an appointment with the doctor on 15Mar2021. She was not feeling well at this point. The patient developed shingles (one spot on the right-hand side on back of head) sometime after 15Mar2021 and was diagnosed on 22Mar2021. The patient had an itchy scalp due to the shingles and claimed shingles caused memory issues and brain fog, since 07Mar2021, (it seemed like she got "COVID brain"). The patient was prescribed Valacyclovir 1 mg oral tablet every 8 hours, 30 tablets, for the shingles on 22Mar2021. The open spot on the scalp crusted over by 01Apr2021 when the patient saw the physician again. The patient stated that shingles has lasting effects: brain fog, can't find the words, short-term memory problems have been coming and going since 07Mar2021, felt liked she has attention deficit disorder (ADD) on steroids, worked really hard to keep focus. This has worsened, maybe manifested more so in the last 3-4 weeks or so. Sometimes when she got anxious, her prefrontal cortex did not function well. After being diagnosed with shingles, the patient began to take propranolol 40 mg in Mar2021 as needed (patient takes 1/8 or part of 1/8 of a tablet, just biting off a tiny piece). Initially when she had shingles, she had "some finger in the light socket, fight or flight internally"; the propranolol helped with this. She took it very regularly in Mar2021 and had taken once a week at most the last 2-3 weeks. The patient also took "Brain Goo" as of 22Mar2021 which caused the stinkiest gas in the universe, and the patient was bloated, (reported as from Feb2021) depending on what she ate, and because of that, the following week, the patient took an anti-gas pill, simethicone. She had muscle cramps (in the left upper thigh on the inside of the leg and outside of the leg) and tightness, in Mar2021, that made it hard to walk. The other area that tended to cramp up and cause problems were the arches, mostly the left arch. She reported it was probably 24Apr2021, she came downstairs in the afternoon or early evening and had such an intense cramp like a Charlie Horse and fell to the floor. Muscle cramps come and go, they shift around, it's in the left arch. It's not intensely sharp like it was that day. Right now, her left arch has a knot. The patient began taking tizanidine around 08Apr2021 at 4mg 1 tablet 3 times a day for muscle cramps and tightness, which can get painful, and tizanidine helps relax that. The patient experienced fatigue due to which the patient cannot go to the grocery store by herself very easily as she gets wiped out. The patient had to hang on to the cart because she does not have the energy. She described fatigue and stamina as she had energy for a while and then she crashed. She reported she had to carry protein with her because she can literally crash. She reported her left leg gave out and she had to grab onto the counter and she almost went to the floor. On 24Apr2021, the patient couldn't talk and could barely open her eyes. It felt like her body was shutting down. She couldn't get herself up off the couch to go to the bedroom. This had not happened again. She told her physician about it who was sending her to a neurologist. On 02May2021, her left hand knotted up- had a cramped muscle and tightness. The base of her thumb hurt (underneath the thumb where the thumb attaches to the hand). The patient felt that sound can hurt her ears, which came and went. The patient had a hard time seeing the computer screen, which started between 01Apr2021- 08Apr2021. The patient mentioned this to the physician. She was nearsighted and wore bifocals and will take her glasses off to see the screen better). Food tasted extra intense as of 15Apr2021. On 06May2021, the patient was exhausted after being on the phone so long yesterday. On 06May2021, the patient reported staring off into space "like she could die and it wouldn't matter" and it felt like her brain was cramped up (like her brain was going to shut down). Caller reported that she has been staring off into space steadily, and it was kind of scary. Caller reported that the staring off into space has not occurred again like the first time where she felt like her brain was cramped. Caller reported that she feels like the staring off into space was connected in the same part of her brain that caused her to not be able to talk or open her eyes on the night of 24Apr2021. The patient reported that the staring off into space had continued on and off but not to that degree of intensity. She reported that the first time she stared off into space, she felt like she couldn't interrupt or stop staring off into space. Caller reported that she doesn't know how she stopped starting off into space the first time, but now when she stared off into space she can move her eyes. Caller reported that it felt like she had a cramp in her brain because she couldn't move her eyes. The staring into space was now better otherwise she would have gone to the emergency room. The patient underwent laboratory tests which included on 01Apr2021 which included: ALT 71 (normal 7-52), sodium 131 (normal 136-144), MCH 34.20 (normal 26-34), MCV 100.30 (normal 80-98), and on 02Apr2021, sodium 144, SARS-CoV-2 lgG Ab Antibody Test: reactive (detected value reactive, range non-reactive). The clinical outcome of staring into space, couldn't talk, "could barely open her eyes / not be able to open her eyes" was resolved on an unspecified date; herpes zoster and itchy scalp that would be due to the Shingles, sore inside my mouth was resolved on Mar2021; hard time sleeping, myoclonic jerks, not feeling well, "short term memory loss/memory problems", skin hurts, intense anxiety, "big emotions, big anger, really really intense", "my body temperature, I can be freezing one minute and so hot ", headache, back pain, neck pain, shoulder pain, exhausted/fatigue, brain fog, " I feel like I have ADD but on steroids", worked really hard to keep focus, muscle tightness, "base of my left thumb hurts underneath the thumb where the thumb attaches to the hand", left hand cramp and tightness, i have a hard time seeing my computer screen, food can taste extra, extra intense, was not resolved; flustered, felt achy, like the flu, can't find the words, hard to walk, fell to the floor, does not have the energy, sound can hurt my ears, ALT 71 (normal 7-52), sodium 131 (normal 136-144), MCH 34.20 (normal 26-34), MCV 100.30 (normal 80-98) was unknown; stomach gas and bloating, muscle cramps was resolving. Follow-up attempts are needed. further information is expected
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| 64 | 2021-05-19 | mental status changes |
Extreme go.lying and nausea, dehydration, couldn't keep down medicines, went into altered state, ki...
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Extreme go.lying and nausea, dehydration, couldn't keep down medicines, went into altered state, kidney failure heart and was in Hospital for March 31 - April 7, was not conscious until.April 5th. Some dr blamed it on the morphine but have had past unconscious hospitalization when sudden withdrawal from gabapentin which resulted from vomiting. Have never had problem with heart kidneys or lungs before this. Was given (medication) three times but it didn't bring me back to normal. As for level of morphine sudden stoppage of gabapetin CA affect the levels in blood. I was told not to get the second vaccine but not one dr in hospital seemed to want to report this and I don't think its right. I am going to have bill from being in intensive care and who knows what this will cost me.
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| 64 | 2021-05-20 | disorientation |
I had to use my walker, from knee surgery 2 yrs ago, to get around. Still difficult- legs and knees ...
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I had to use my walker, from knee surgery 2 yrs ago, to get around. Still difficult- legs and knees hurt pretty bad. Husband said I was ?talking out of my head some?, was very tired. It passed after one day. *Please make note that I did have Covid in January- in my lungs. I did not report to my dr- but I will
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| 64 | 2021-05-21 | anxiety, feeling abnormal |
This is a spontaneous report from a contactable consumer (patient) and a physician. A 64-year-old fe...
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This is a spontaneous report from a contactable consumer (patient) and a physician. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 in the afternoon around 2 or 3 o clock (Batch/Lot Number: EW0153) as 2ND DOSE, SINGLE for covid-19 vaccination. The vaccination was done in her building, a medical team came to them. She lives in subsidized housing. The patient's medical history included tendonitis; juvenile idiopathic arthritis from Dec 1969 and ongoing; lupus nephritis from 1989 (diagnosed ten years after SLE); systemic lupus erythematosus (SLE) from Dec 1979; discoid lupus; proliferative kidney disease stage 3; sjogren's; raynaud's; arthritis (since she was 13); bursitis; oral necrosis (this was from being on a calcium drug that they give menopausal women, it was out of her head right now when reporting. She could not think of the name. The drug was supposed to promote bone growth and keep her from getting osteoporosis); menopausal (because of chemo she started menopause at 42); vulvar lichen sclerosus; filamentary keratosis from 2015 and ongoing (this was since either Feb 2015 or Mar 2015); kidney cysts(one is benign and one is being watched); liver hepatic hemangioma; allergies (Allergies to aspirin, penicillin, dextrose IV, Biaxin, Levaquin, Cipro, band-aid adhesive, zofran, sulfa topical. The sulfa is a topical as opposed to being the sulpha with a ph.); adeno conjunctivitis from Jan2015 and ongoing (she had a really bad case of this in JAN 2015 and had to quarantine for three weeks. She lost her vision, she could not see for three days. She got a fever. It left her with a filament thing. It is just delightful. It is viral and really bad. She got it at her eye doctors office when she was there for an annual visit. She sometimes had to go there 3 times to have filament growing on her eye scrubbed off. It is wicked painful. It is quite an adventure.); she used to be three quarters but she shrunk a little; has been a couch potato for a year, it comes with the territory with lockdown and being depressed; she is immunocompromised and catches many things and is high risk She feels like a sitting duck; had issues on her palm of hands; had issues on her breasts, and chest; and various problems. Family Medical History Relevant to adverse events was none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No other vaccines administered on same date with the Pfizer vaccine considered as suspect. Concomitant medications included vitamin b complex (B-COMPLEX 100) 100 as dose did not clarify units, has been on for years; hydroxyzine embonate (HYDROXYZINE PAM) Dosage 25 mg, she did not remember indication, may be allergies, if she is around a cat, she takes it prophylactically; acetylsalicylic acid (ASPIRIN) low strength, 81 mg twice a week, has been on for decades, nephrologist put her on it in the 90's and She did not remember why, he said it preserves kidney function or it is good for overall health; pentoxifylline ongoing at 400 mg, 3 a day, she has been on for years, her vascular doctor prescribed; prednisone dosage:1 mg, she takes and alternates between 6 and 7 mg, If she takes lower than that, she is a "narcoleptic" (as reported, did not clarify); rosuvastatin Dosage:10 mg, frequency not specified, it is a nightly thing; fish oil (SUPER OMEGA 3) overall supplement that was suggested by former nephrologist at some point some; estradiol (YUVAFEM) Dosage:10 micrograms for menopause, vaginal dryness; there was no variable in her medication routine, she is on a long list of medications (she could not remember, one was blood pressure, with the last administration she was worked up and her blood pressure would not come down, she also takes Tylenol as needed), she provided the details as she knows them, but did not know full details for all of her medications. There was nothing new to her routine except like when Prilosec was taken off the market, she got a different medication for it. She has been on all of these for long term maintenance. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19MAR2021 (at the age of 64-year-old)(Batch/Lot Number: ER2613) for covid-19 vaccination, adverse events following prior vaccinations: none; and flu vaccine for immunization in last fall, 2020. She has a history of obscure side effects to medication, things that people have never heard of and she is the 1 in a million that has ever had these problems. The patient previously took ondansetron (ZOFRAN), ("a chemotherapy treatment", given before chemotherapy), which gave her a homicidal migraine and they had to give her ice packs for her head; 9 rounds of "Cytox" (Cytoxin or Cytoxan) she was not sure how this was spelled, and chemotherapy (9 rounds of chemo); azathioprine (IMURAN), she does not know if it was spelled Immuran or Imuran; prednisone a number of years and she said to her rheumatologist, "it did not make sense on an intellectual basis that the prednisone being effective in her body as it was once" and he said he would give her IMURAN which is given to kidney patients to cause less of a reaction with the organ, and patient mentioned she had barely an immune system after all these years on prednisone, she went through 3 rounds of steroids; Heparin IV, which made her arm feel on fire on the inside, which they would not give her a flush when she had IV treatment; Dextrose IV made her skin feel hot and itchy, her mouth felt like she put something in that had been soaking in rubbing alcohol; ciprofloxacin (reported as "Cipro"), she had a bad reaction to Cipro, she was given after she was bit by a dog on her calves, she knew it was attached to and is "hurting her calves the rest of her life/the podiatrist said if it has not gone away, she is kind of stuck" (as reported, not specified). The patient just wanted to give Pfizer a full picture of what she was dealing with and she is an unusual case. She added that chemo was in the 90s and that is when all of the medication reactions she mentioned were. She absolutely does not have any of the information about the products she mentioned she had previous reactions to. Every time they did "this", it "hurt" and she asked them not to do it anymore. She asked them to not do dextrose anymore with the chemo because it feels like it is on fire, and she asked them to mix it with saline. She did not have any additional information, did not have the NDC, LOT, expiration date, or manufacturer for any of these medications she reported historical adverse events on. The patient reported that she got her 2nd shot of the Pfizer covid vaccine on 09Apr2021. She has soreness at the site, more-so several hours after getting the vaccine (09Apr2021). Just her arm felt sore within moments after the second vaccine, but she did not get this after the first. She rested and took it easy that weekend. There was Sore, Tired, general lethargy, and fatigue (Apr2021): when she looked online, it really only told her what everyone knows about that you might be sore and tired and she had all that, she thought she was through with all of that. She had no chills, just general lethargy and fatigue. She was sluggish and tired and not herself that weekend (Apr 2021). She stayed home so it is difficulty to say. Her arm was definitely sore. For sluggishness and fatigue, she said that she has been a couch potato for a year, it comes with the territory with lockdown and being depressed, so it is difficult to decide if it is health or physically induced or a emotional base. She did not knowingly spike a fever, no chills or sweats. And on Monday (did not clarify dates but states it was Monday after 09APR2021, throughout the weekend she took it easy), she noticed with her foot, she had difficulty getting out of bed could not put weight on her right foot. She was alarmed. She stayed home and rested and did a lot of napping and taking it slow. It is still difficulty and moving certain ways hurts more if she flexes. She has a known history of tendonitis so she wore her brace in the meantime. She thought maybe she had tendonitis in both ankles and this was similar so maybe it was a different set of tendons. She would wear a brace, and eventually it will get better in time. She also was wearing braces like compression socks that toes stick out of. She thought she had tendonitis and that is what she has done in the past. It has been a month and she is not better. This was her left foot, most of the pain was focused on the sole of her foot towards the outer edge. That is where it started. Then it migrated over time. That was weird and had her worried. It was all in her arch in the initial spot. She notes it is not like the tendonitis she had the first time. She does not want to be an alarmist or have her doctor think she is a hypochondriac she waited. She was then rubbing her foot, the right one, and noticed it was tender on the top of her foot just like the left one. There was sore. There was pain in right foot, pain in feet. Pain in feet, her left foot had most of the pain on the top and bottom and a lot of it is along the outer part of her sole of the foot. In her right foot, the pain is mostly at the fleshy part below her toes and on top of her foot. The pain moved around into the other foot for about a month so she went to the podiatrist yesterday (06May2021) and doctor did x-rays. The night before (05May2021), the opposite leg had a line of black and blue dots on her right calf that went up her leg, she did not notice this until Wednesday (05May2021) evening because she never examines it. She soaped up a washcloth and she knew where her parts are in the bath. Her mind wanders and she was not looking. She happened to be wearing something where her legs were not covered and that is how she knew. It did not hurt. It was strange, looking like bruising in a line. The doctor said it was all like one vein and he cold feel it. She can not feel it, but he could. The doctor told her these could be clots. She still has them. Doctor said the other leg where she had the pain was only soft tissue pain. Doctor found that every place that hurt when he touched it and it still hurts where he had touched it. She was told she does not have arthritis and she has had arthritis since she was 13. The doctor did not know what it is. It was her left foot constantly, and the right foot hurt off and on during that period. The left for sure was kind of a dull ache and throbbing. The right was only a little bit. The left was worse. It appeared to be soft tissue that was hurting and he said there are so many side effects of this new vaccine and to maybe try heat or ice. Ever since the patient left doctor's office until now (the time of reporting) she did not known if she need to be concerned, that if she does not know what it is, can ice or heat make it worse? She did not know the next steps. Treatment, she tried to keep it elevated because that can not hurt but that is about it. She has not done heat and ice because if the doctor does not know what it is, how does he know it will not make it worse. He asked if she could take aspirin and she said no she is allergic to aspirin. Tylenol she does not take often, only when she feels like she needs it and she has not been doing it often. When she stays off it, it does not hurt as much as when she is walking. She wanted to know if she should be worried and she wanted to add (report this) to the database if this is a side effect and if Pfizer has ever heard of this before. There was also tired, general lethargy, and fatigue. At this point when reporting, she is single and lives alone, and said that "God forbid something happens, there is nobody to say let's get you to a hospital". She heard about blood clots on the news. When they said blood clot yesterday, it was a red warning light going on and a siren. At the time of reporting it was Friday and she did not know that if she need to rush to the hospital. Her primary care physician (PCP) said she had never heard of this and to call Pfizer. The patient asked if she is one of a small group of people this has happened to. She asked if she should not worry and it will go away or should she get to a hospital. She thought she had a problem with her feet (foot problem) but her podiatrist does not know what was going on. She communicated with her physician office today and she said she has never heard of this. She wanted to know if her symptoms have been heard of and if she should go to the hospital. The events did not require a visit to emergency room. The patient underwent lab tests and procedures which included: height as "5 and three quarters of an inch feet (5'0.75")" on an unspecified date; rapid COVID-19 test on 06May2021: negative; regular COVID-19 test on 06May2021: negative; x-ray on 06May2021 to make sure she did not break anything: unknown results. She also went because she had not done it in a year and she had something from the health department saying to get tested weekly for the virus (clarified that she was talking about the COVID tests as what she went and got done). The outcome of the events was unknown.
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| 64 | 2021-05-26 | anxiety |
1 week after large red welt hard and dark red at injection site, 2 day side of face ached and neck s...
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1 week after large red welt hard and dark red at injection site, 2 day side of face ached and neck started itching and the welt spread on the arm, 3rd day it was itchy scalp and hot flashes then welt spread more, 4th day ears were ringing and anxiety started. It took about 2 weeks for it to go away.
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| 64 | 2021-05-26 | feeling abnormal |
Intermittent fevers (up to 103.1); inflamed asthma symptoms; bronchitis; chills; brain fog; vertigo;...
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Intermittent fevers (up to 103.1); inflamed asthma symptoms; bronchitis; chills; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730) via an unspecified route of administration in the left arm on 02Apr2021 15: 15 as single dose for COVID-19 immunization. Medical history included allergy induced asthma and hypothyroid. Concomitant medications included levothyroxine, simvastatin, omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced 4 weeks of intermittent fevers (up to 103.1), chills and inflamed asthma symptoms including bronchitis and brain fog. Then, week 5 just as the patient was beginning to feel better, vertigo. All stated on 03Apr2021 21:00. Treatment was received for the adverse event with steroids, antibiotics. The events result in: doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test post-vaccination on 27Apr2021 And on 12Apr2021, both via nasal swab and with negative results. Outcome of the events was not recovered. This report is reported as non-serious.
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| 64 | 2021-05-26 | irritability, memory impairment |
mild sepsis; It was normal, except her bladder, because it was so swollen she felt like she couldn't...
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mild sepsis; It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely; swelling in her brain; thyroid felt swollen; gained 10 pounds overnight of fluid.; lymph nodes got huge; headache; Her tongue feels swollen; Pain in all her organs; Her arm was so sore/ sore left arm; so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks; gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too; affected her brain and speech/difficulty pronouncing words; Affected her brain and speech; allergic reaction; experienced a personality change; feeling puffy; felt like she had a tourniquet around her neck/Her organs felt swollen; cognitive issues; Throat swelling; pain in the part of her liver; couldn't remember where she put things; muscles did not work right; bladder infection; She was so cranky; Intense stomach ache; This is a spontaneous report received from a contactable consumer (patient reported for herself) from a Pfizer- sponsored program. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 08Apr2021 at the age of 64 years old (Lot Number: ER8732) as 2nd dose, single for covid-19 immunisation. Medical history included Cancer: Gerson Therapy; Autoimmune disorder; allergies ongoing; Parvovirus B19: exposed to Parvo B virus, it's called the 5th Disease, she had a rare reaction to it and it gave her Rheumatoid Arthritis ongoing, Fibromyalgia ongoing, Multiple Sclerosis ongoing and Behcet's like overnight; allergies to food (she got swelling, intense depression, suicidal tendencies, and a fight or flight response), drugs (Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet), air, dirt, trees, and bugs. It runs in her family; inflammation. Concomitant medications included ongoing fish oil (FISH OIL); ongoing curcuma longa (TURMERIC [CURCUMA LONGA]); several other supplements; ongoing Benadryl for allergies when need. The patient previously received the first dose of BNT162B2 on 19Mar2021 09:00 at the age of 64 years old (lot number: EN6207) in Left arm for Covid-19 immunization and experienced allergic reaction, throat itchy, numbness on her left side/ Legs were like spaghetti and she felt like the scarecrow in Wizard of Oz, lungs itchy and inflamed, coughing, barking asthma cough, Speech slurred, Oxygen level felt like it was in the 80s (80%), muscles not responding, Crooked walk, died 6 times and experienced an out of body experience. Vaccination Facility Type was Hospital. Vaccine was not Administered at any Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Caller wanted to know about the need for booster dose; Was it going to be like the first or second dose of the vaccine. Caller wanted to know the ingredient of the Pfizer covid vaccine. She said she took both of the doses and had a bad reactions from it. Caller stated she had a lot of issues with the first dose but not as bad as second dose. The second dose almost killed her and affected her brain and speech. She had the Pfizer Covid-19 vaccine, and experienced a bad reaction after both doses. Caller asking what was in the vaccine that could cause her bad reaction. She never had a reaction to any vaccine. She had allergies and autoimmune disorder. Her arm was so sore/ sore left arm the first time. It was difficult to get in and out of car for 3 weeks, but she recovered completely. She helps the handicap people, so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks, but she recovered completely. Caller added she needed to decipher what was written on the vaccination card. She wished they would write better. She used her glasses. Caller took no pharmaceuticals, just Benadryl for allergies when need. The Hospital where she received her vaccine was used and created by another facility, but not a an offsite facility. But for them to use also. Caller added she was cured of everything she had from the Therapy. After the second dose: She started same day as vaccine on 08Apr2021. She did her protocol that time, and as far as breathing and that, it was not like the first dose, but towards the evening she had an auto immune response that lasted for 3 weeks. She felt like she experienced mild sepsis and gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too. When this happened it started with feeling puffy that evening and lasted for 3 weeks. Caller added if she was exposed to a virus, or had an allergic reaction this happens. Caller added even her lymph nodes got huge and thyroid felt swollen, felt like she had a tourniquet around her neck. That lasted for 3 weeks. It was bad the 1st week. That caused a severe headache that started on the 3rd day and lasted 4 days. It was really bad on the 1st day and she wanted to go to the Emergency Room. She took Benadryl and Ibuprofen, and a Doctor told her she shouldn't take Ibuprofen because of Covid. She was allergic to Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet, Everything except Ibuprofen. Caller did not have the bottle to provide details. She usually put Ibuprofen in her Benadryl bottle for her inflammation. That was the only thing that she took. She took Turmeric and fish oil and several other supplements. Her headache peaked on the 4th day, and she took the Ibuprofen and was better the next day. Throat swelling started on the 5th day and lasted and was still causing her difficulty pronouncing words. Her tongue felt swollen. Her cognitive issues started the 4th day of her headache and was intense. It continued, but was much, much better. She did her normal protocol, and had gotten by, but it was not normal. Her organs felt swollen and the doctor did a test. It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely. The muscles did not work right and she got an bladder infection and received antibiotics, about 2 weeks after the injection, because her bladder wasn't working right. Urine test: infection. Intense stomach ache: started at the time her headache stated after 3 days along with the headache and ended with her doing the Therapy. They lasted for 4 weeks. Pain in all her organs: started the 3rd day after the second dose. The pain started, she felt swelling and it lasted for 3 weeks, actually, for 4 weeks, the pain in the part of her liver by her stomach. She experienced a personality change and she wouldn't have the vaccine again. She couldn't remember where she put things, started on the 7th day after her second dose and lasted until the Therapy made her feel better. Finally, after 4 weeks, she recovered completely and was pretty much back normal now. Caller added she was a happy person and was with her Cancer. People asked how she did it. But with this experience she literally wanted to hurt someone or kill herself, and no it was not normal. She was so cranky. She was sure it was the swelling in her brain. With her food allergies she got swelling, intense depression, suicidal tendencies, and a fight or flight response. She wanted to leave her life, it was scary. Caller added she did not feel like this now. For the Vaccine Indication: Caller added that people that need it most, didn't want it. Because of her autoimmune disorder, she was a long huller and she had died 6 times, so she was willing to try it and take it and deal with the side effects. She was hoping it would not cause any. Her boyfriend died at Christmas. After 24 hours he was dead. He had a mild sepsis from a virus. He has Autoimmune disease. If she got Covid, she didn't want to end up like him and see her arms and legs amputated. Caller asked if anyone else had reported symptoms she had experienced. Caller asked to clarify details of her symptoms of suicide and killing and hurting others. Caller denied she was experiencing this at time of call. Therapeutic measures were taken as a result of events headache, Personality change, couldn't remember where she put things, bladder infection. The outcome of the events Pain in arm, Pain in hip, Personality change, couldn't remember where she put things, Stomach ache was recovered on an unspecified date, of cognitive issues was recovering, of the other events was unknown.
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| 64 | 2021-05-27 | feeling abnormal, insomnia |
Shingles; itching around the nipple area at that time.; a pain under her arm and on her back; 2 bout...
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Shingles; itching around the nipple area at that time.; a pain under her arm and on her back; 2 bouts of diarrhea; palpating and fluttering; felt like she got hit by a truck/was feeling miserable; sore arm; stuffy nose; sweating really bad; chest was fluttering on and off; hearing was muffled; headache; restless night.; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0165; Expiration Date: 31Aug2021), via an unspecified route of administration on 05May2021 (at the age of 64-years) as 1st, single dose for COVID-19 immunization. Medical history included unspecified allergies. The patient concomitant medications were not reported. On 05May2021 (same day after vaccination), patient developed a headache within the first 15 minutes. She stayed 30 minutes after the COVID vaccine because she has a history of allergies and then she went home and took Tylenol. She was resting that whole day and then she had a restless night. On 06May2021 (one day after vaccination), when woke up, patient felt like she got hit by a truck and had a headache, sore arm, stuffy nose, she was sweating really bad but there was no fever, and her chest was fluttering on and off. Patient ears felt like they were blocked because her hearing was muffled. On 07May2021, patient woke up with a really bad headache, worse than the day before, she had heavy sweating, her hearing was muffled, she had a stuffy nose, and she had the palpating and fluttering that continued. She had no fever. On 08May2021, she woke up with no sweating finally, but she had a real bad headache, her nose still felt congested, her hearing was still muffled, and she was feeling miserable. She had 2 bouts of diarrhea. She was basically nursing with Tylenol at that time. On 09May2021, patient had a slight headache, no sweating and she felt a little bit better in the morning but not 100%. Then she developed a pain under her arm and on her back and she could not lay on her left side. The pain was radiating from the front to the back. She took Tylenol and that did not help, and she could not sleep. On 10May2021, patient had a doctor appointment that was already scheduled so she went to see the doctor. Before she went, when she woke up her ears were still blocked, she had pain on her left side and itching around the nipple area at that time. When she saw the doctor, she was diagnosed with shingles and gave her medicine. Patient received unspecified treatment for the event Shingles and before that patient took Tylenol. The Tylenol she took was only 325 mg because she was sensitive to chemicals in medicines. The lowest dose was usually all she has taken, and it will be enough to relax her to fall asleep, but it did not touch the pain on Sunday night. Patient was worried about the second shot. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 64 | 2021-05-28 | feeling abnormal |
Had to use bathroom in the middle of the night and I became really dizzy, started sweating and then ...
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Had to use bathroom in the middle of the night and I became really dizzy, started sweating and then fell onto the bathroom floor. Crawled back to bed and continued to feel bad until about 9 am. Then I was just really tired the rest of the day.
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| 64 | 2021-05-28 | insomnia |
This is a spontaneous report from a contactable consumer (patient). A 64-year-old non pregnant femal...
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This is a spontaneous report from a contactable consumer (patient). A 64-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number: EN 6205) via an unspecified route of administration, administered in left arm on 02Mar2021 at 16:45 (at the age of 64-year-old) at a single dose for COVID-19 immunization in Public health clinic/veterans administration facility. Medical history included known allergies: sulfa, penicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included (received in two weeks) naproxen sodium (ALEVE), vitamins nos (MULTIVITAMIN) curcuma longa (TURMERIC), ubidecarenone (COQ10), berberis vulgaris root, camellia sinensis leaf extract, coptis chinensis root, curcuma longa rhizome, fallopia japonica root with rhizome, origanum vulgare leaf, rosmarinus officinalis leaf, scutellaria baicalensis root, zingiber officinale rhizome (ZYFLAMEND). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 1:15, the patient had a terrible headache on top of her head- it woke me up the middle of the night and patient could not go back to sleep, body aches, chills, exhausted to the point of missing work, loss of appetite, thirsty, lymph node under left arm (vax site) enlarged. 4 days later (as per report), patient still felt a bit under the weather. Patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 64 | 2021-05-31 | feeling abnormal |
On the morning of May 14/21, I was walking and all of a sudden my left foot went numb and I couldn't...
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On the morning of May 14/21, I was walking and all of a sudden my left foot went numb and I couldn't feel my foot stepping on the ground. The numbness went up my left leg while at the same time, my left hand started to go numb, starting at my baby finger and working over to my thumb. I thought I might be having a stroke so I called my PCP and they recommended I go to the ER. There I was given a head CT and an MRI of my brain along with blood work. Everything came back normal. I went home later that day and found I was extremely fatigued through the weekend. Then Tuesday morning (05/18) I felt light headed and very unstable. I went back to the ER and another CT scan and MRI were done. Again both came back normal . I am currently wearing a ZIO heart monitor and I had an echocardiogram May 27, which also was normal. None of the doctors I spoke with were able to offer an explanation for my symptoms.
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| 64 | 2021-06-02 | sleep disorder, feeling abnormal |
Rash up and down and all over her arms; Couldn't breathe when laying down; Tiredness; Heart rate hig...
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Rash up and down and all over her arms; Couldn't breathe when laying down; Tiredness; Heart rate high; She felt hot and cold all day; Breasts were tender; She couldn't sleep; She doesn't feel like herself. She is scared.; MRSA; Bronchitis; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Fever; This is spontaneous report from contactable consumer. This consumer (patient) reported that the 64-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 like 11:00 12:00 in morning, was before noon (Batch/Lot number was not reported,Is hard to read, could be EN8208 or EN6206, either of the 8's could be 6's; Expiration Date: 30Aug2021) as 1st dose, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing (Diabetes is not very high. Is almost like Pre-diabetic. Recently diagnosed with it, she has been sitting around because of Covid.), anxiety from an unknown date and unknown if ongoing. Family Medical History was none. Concomitant medications included ongoing lorazepam (LORAZEPAM A) at 0.5mg as needed for anxiety for a couple of years, about 3 or 4 years; ongoing metformin hydrochloride (METFORMIN [METFORMIN HYDROCHLORIDE]) at 500 mg, 2x/day (500mg twice a day) for diabetes mellitus for a couple of months (She started this medication 2 months before the covid vaccine); cannabidiol (CBD OIL) takes as needed. The patient experienced mrsa (staphylococcal infection) on an unspecified date with outcome of unknown , bronchitis on 16Mar2021 with outcome of unknown, fever on 14Mar2021 with outcome of recovered , swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, rash up and down and all over her arms on an unspecified date with outcome of unknown, couldn't breathe when laying down on an unspecified date with outcome of unknown , tiredness on an unspecified date with outcome of unknown, heart rate high on an unspecified date with outcome of unknown, she felt hot and cold all day on an unspecified date with outcome of unknown, breasts were tender on an unspecified date with outcome of unknown, she couldn't sleep on an unspecified date with outcome of unknown, she doesn't feel like herself. she is scared on an unspecified date with outcome of unknown, had the vaccine 9 mar 2021/she is 65 and is afraid to get the second shot but is also afraid to not get the second shot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included echocardiogram normal: normal on unknown date. Therapeutic measures were taken as a result of bronchitis , heart rate high. The clinical course was reported as follows: Caller received the first dose of the Pfizer COVID vaccine on 09 MAR 2021. Caller states the past couple of months she has experienced a lot of adverse events. Caller states she has had issues with bronchitis and went to a pulmonologists and cardiologists and she has been put on 27 different medications. Caller states after all of these things going on she is not sure if she should receive the second dose. Caller states one doctor told her she should not receive the second dose and one doctor told her she should. Caller would like to know if she should receive the second dose of the Pfizer COVID vaccine. Caller states her doctor doesn't want to tell her what to do because she thinks he is afraid that she might sue him. Caller thought that by calling Pfizer she would get some advice but she is getting nowhere. Caller would like to know if she can receive the Johnson and Johnson Covid vaccine as her second dose instead of receiving the Pfizer COVID vaccine? Had the vaccine 9Mar2021 and is just recovering now. Last week, she was finally feeling like herself. She had some medical conditions that put her at risk. She is 65 and is afraid to get the second shot but is also afraid to not get the second shot. Her doctor thinks it is too coincidental that this happened right after the vaccine. Has been talking to a lot of doctors. Is afraid to get the second vaccination. So now, she is just trying to figure it out. It really knocked her out, she has had 27 medications, she's been to the ER 3 times, been to the doctor 7 times, it just really knocked her out, they first thought it was a heart condition, then a lung condition. Has been having rashes and all kinds of stuff. Is afraid to not get the second dose. One of her doctors recommended the Johnson & Johnson, but is that safe, no. Weight was about 200 pounds. Started 5 days after the vaccine. Fever: On Sunday, started to get a fever. It was on and off all day. She thought it was a normal reaction and didn't think much of it. It was weird. It would be like 20 minutes and then fine, and would be off an on all day. It was a low grade fever, never more than 100. she felt hot and cold all day. It was most of Sunday and stopped in the evening. Treatment: none. Swelling and pain under breasts, under armpits and in lymph nodes: Started Monday. Breasts were tender as well as if like she was having a period. There was pain underneath her arm and in the lymph nodes. Lasted for 2 days. Treatment was none. Felt like bronchitis: On Tuesday, it started to get what she thought was bronchitis. She has a propensity to get bronchitis. She hasn't gotten sick in 2 years. She immediately went to the doctor. This went on for 2 months. Treatment: They prescribed Prednisone, nebulizers and antibiotics which she finished everything 3 weeks ago. She couldn't sleep and had to sleep sitting up, she couldn't lay down, it started right away when she felt she had the bronchitis. Rash up and down and all over her arms: She then developed a reaction and had a rash up and down her arms, all over her arms. Felt the bronchitis symptoms right away. It was the weirdest thing and she couldn't lay down. Every time she would get up, she couldn't breathe. Went to the emergency room 3 times but was not admitted. At one point, she had a rash all over her body. Her doctor thought it was MRSA. This happened a month into all of this. She got the vaccine 8 or 9 Mar 2021. This rash occurred some time in mid April. When it started, the rash was everywhere in her body. It was so severe, that they thought it was MRSA. Gave her another bout of antibiotics. She had sores that were opening all over her body. She then went to the Emergency room and they treated her there. The other time she went to the emergency room because she couldn't breathe. She had to sit in a Lazy boy chair for 2 months. The pulmonologist and the heart doctor couldn't find anything. When they though it was bronchitis, they treated her for 2 months with Prednisone. She got Candida's from the Prednisone. They put her on 27 medications total. The pulmonologist said it was not the lungs, it was the heart. She was put on medication to slow down the heart rate. It had been running about 119. The medication she was put on was Metoprolol Tartrate 25mg. It slows down the heart rate, it has been so high. She was put on the medication 23 Apr 2021. It went so high. Her oxygen has been good. Her heart rate was never slowing down. She is still taking the Metoprolol, her rate is running like 118 and 108, it never slows down. The pulmonologist said it was not the lungs, its the heart and she is going to see him tomorrow for a follow up echo. She is so sick from so many medicines. Is still experiencing a lot of tiredness. It is the weirdest and is very strange. When she was laying down and couldn't breathe, the doctor said they felt like she was going into heart failure. The Echo didn't find anything wrong. It was a weird thing. She talked to both of the doctors, the pulmonologist and the family doctor who said that it was too coincidental that it was from the Pfizer. The Echo was a week and a half ago. The family doctor read it sand it looked normal. The pulmonologist who ordered the test is going to check it tomorrow. Her family doctor said to not get the second shot. The other doctor said she could probably take it. She doesn't feel like herself. She is scared. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Event bronchitis like symptoms required a visit to Emergency Room for 3 times and Physician Office and has been to the family doctor at least 5 times. No prior Vaccinations (within 4 weeks) but had the flu shot in the fall. AE following prior vaccinations was none. Relevant Tests was none or Unknown. Caller states that she is overweight. Caller states that she is trying to get out of here to go to a doctors appointment. Caller states that she has the bottle, she will ask her spouse to read it since she can see better, the product is Metoprolol Tartrate 25mg. On the bottle it also described the pill as Round white tablet 51:M18. Caller needs to obtain a magnifying glass. Caller states that she wants to give enough information to what happen to her. She states that the Manufacture is Mylan. Information about the lot/batch number has been requested.
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| 64 | 2021-06-03 | confusional state |
mental confusion; difficulty speaking; severe headache; This is a spontaneous report from a contacta...
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mental confusion; difficulty speaking; severe headache; This is a spontaneous report from a contactable other hcp. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 11:00 hr (at the age of 64-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included Rheumatoid arthritis, gastro-oesophageal reflux disease (GERD) and drug hypersensitivity to penicillin (allergies with PCN) from an unknown date and unknown if ongoing. Concomitant medication included methotrexate (METHOTREXATE), hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); omeprazole (OMEPRAZOLE); pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced mental confusion, difficulty speaking, severe headache on 04Mar2021 23:00 hr. Lingering feeling of not being completely back to normal after another additional day. No treatment received. The outcome of the events was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
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| 64 | 2021-06-03 | excessive sleepiness |
I received my second Covid19 vaccine about 9:30AM Friday April 16, 2021. The next day, Saturday, I w...
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I received my second Covid19 vaccine about 9:30AM Friday April 16, 2021. The next day, Saturday, I was on bed all day - exhausted. I didn't eat or get up. On Sunday, I was still fatigued and had some vomiting and diahrea. I was again in bed all day. Monday: fatigued and unable to get up and going. Tuesday: same - for the entire week. After a week's time, I was still fatigued and began having a low grade fever. This situation lasted for TWO WEEKS. At the 14th day after my second vaccine, I went to the clinic and got urine and blood tests because I thought something was wrong with me. All came back negative. The next day ( again, TWO WEEKS after the second shot), I finally felt better.
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| 64 | 2021-06-03 | loss of personal independence in daily activities | Exhaustion; couldn?t function |
| 64 | 2021-06-06 | feeling abnormal |
She got her vaccine, she had a sore arm/shoulder area but that went away within 24 hours. Then abou...
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She got her vaccine, she had a sore arm/shoulder area but that went away within 24 hours. Then about 2 days later her upper lip had tingling, and then burning, and three different places on her upper lip had clusters of blisters. They were painful sores. Right now three places are red, burning, and she bought an Vibrant Health Gigartina Red Marine Algae ointment that bought in store and the pharmacist told her to get it. It was good for cold sores, chapped lips, and kept putting it on her lips, which did not help. The blisters have finally gone away and has a wound like area in three spots on each corner of her mouth and one in the middle, especially the right side the two are closer in the middle. She said she feels like she is dying, bombarded with these symptoms and you don't know how to fix it. She wishes that they had studied the vaccines more and that there was a treatment know to treat Herpes Zoster or that these symptoms were out there and what to expect.
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| 65 | 2021-01-02 | excessive sleepiness |
Temp. 102, chills, body aches, headache, extreme fatigue; slept most of the day on the 1st; still w/...
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Temp. 102, chills, body aches, headache, extreme fatigue; slept most of the day on the 1st; still w/body aches, less fatigue, decreased headache, temp 100 on 01/02; back to normal by 2:00 on 01/02
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| 65 | 2021-01-03 | feeling abnormal | low fever, chills, aches, foggy head and fatigue |
| 65 | 2021-01-05 | anxiety | Racing heart maximum rate 156 Palpitations Anxiety Symptoms lasted approximately 4 hours |
| 65 | 2021-01-05 | anxiety | dizziness, tachycardia, feeling of impending doom, lightheaded feeling |
| 65 | 2021-01-05 | impaired work ability |
Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narr...
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Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narrative: Did not have to seek any medical attention, symptoms began to resolve after 3 days, but was off of work for a day. Mostly recovered, just slight vertigo.
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| 65 | 2021-01-05 | sleep disorder |
Patient reported experiencing extreme bruising and warmth at the injection site. Patient could not s...
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Patient reported experiencing extreme bruising and warmth at the injection site. Patient could not sleep on right side due to pain.
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| 65 | 2021-01-07 | feeling abnormal |
Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; Th...
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Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
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| 65 | 2021-01-07 | sleep disorder | awake most of the night, body aches, muscle pain, joint pain, chills, nausea, HA, ok today |
| 65 | 2021-01-09 | impaired work ability, sleep disorder |
Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of s...
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Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue
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| 65 | 2021-01-10 | feeling abnormal | Swollen neck starting below right ear down jaw line. Tenderness and full feeling |
| 65 | 2021-01-11 | sleep disorder | Palm tingling enough to wake from sleep Sore arm Site injection pain |
| 65 | 2021-01-12 | fear |
lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after t...
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lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after the second vaccine and she is afraid; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular (left arm) on 06Jan2021 at single dose for covid-19 immunisation. Medical history included blood pressure (abnormal) and blood cholesterol (abnormal) from an unknown date. Concomitant medication included lisinopril (LISINOPRIL) for Blood pressure for 3 years and adenosine (TRICOR) for cholesterol for 6 months; from unspecified dates and ongoing. On 06Jan2021, 50 minutes after the dose, her lips and nose were tingling described as tingling like when a dentist puts your mouth to sleep. It lasted about an hour. She took Cetirizine which she is sure helped. Within the hour of taking Cetirizine it was gone/resolved. She is afraid for the second vaccine. She has heard that you feel sicker after the second vaccine and she is afraid because it is her mouth. She also stated she took Ibuprofen an hour before hand to ward off evil (as reported). She took 400 mg. She asked if there is information on tingling and if it would be worse after the second dose. Outcome of the events lips and nose were tingling was recovered while unknown for "She has heard that you feel sicker after the second vaccine and she is afraid". Information about batch/lot number has been requested.
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| 65 | 2021-01-12 | feeling abnormal |
Patient states that a couple of minutes from receiving the vaccine she got a hot flash. About 10 min...
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Patient states that a couple of minutes from receiving the vaccine she got a hot flash. About 10 minutes after the vaccine the patient states that her mouth and face started drooping on left side. She took a drink and it felt weird.
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| 65 | 2021-01-14 | feeling abnormal |
Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 min...
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Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 minute wait post covid 19 vaccine. Patient complied. After initial 30 minute wait, patient complained her mouth was dry and asked for water. Water provided, patient denied other symptoms. Based on history patient advised to wait another 20 minutes, and notify staff prior to leaving. 5-10 minutes later husband alerted nurse that she was feeling worse. Upon assessment, patient complained of swollen tongue, and difficulty swallowing. Adverse reaction protocol initiated. Client laid on cot, vitals taken, EMS called. Tourniquet applied above vaccination site, distal pulse check every 5 minutes. Nasal cannula, 4L applied. Blood pressure high, patient became flushed, complained of worsening in swallowing. Epi pen given in right thigh, Benadryl given IM in right deltoid. EMS arrived and took over care. Patient transported to hospital.
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| 65 | 2021-01-16 | confusional state, poor quality sleep |
Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to...
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Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to get a thermometer -while in bathroom the room started spinning and I fainted or passed out. I came to on the bathroom floor and managed to crawl back to the bed. There was confusion and the inability to understand what was going on. I remained in bed until the next morning when all symptoms abated except for some fatigue.
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| 65 | 2021-01-20 | loss of personal independence in daily activities |
In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea a...
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In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
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| 65 | 2021-01-21 | feeling abnormal |
First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle...
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First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle and joint pain x 7 days with low grade temp and chills. Fatigue Second dose: low grade temp and chills and body aches x 10 days. Fatigue. Brain fog
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| 65 | 2021-01-21 | feeling abnormal |
Monitored for 15 minutes at facility. Left and came home. Within 1hour I was lightheaded and dizzy. ...
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Monitored for 15 minutes at facility. Left and came home. Within 1hour I was lightheaded and dizzy. Mental fog and exhaustion. Symptoms lasted through. 1/21/2021. Today mental fog lifted, lightheaded but not dizzy. Not as sleepy. Seems to be lessening as day goes on (1/22/2021)
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| 65 | 2021-01-21 | feeling abnormal | Severe migraine Brain fog Lymph node under left arm is extremely painful to touch Body aches |
| 65 | 2021-01-21 | feeling abnormal |
First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second:...
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First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second: chills and low grade temps x 10 days. Joint pain x 10 days. Itching on day 13. Intermittent headaches and brain fog x 10 days.
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| 65 | 2021-01-21 | excessive sleepiness |
Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigu...
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Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigue,. Got up on 1/21 still slightly achy but headache all day. Slept a great deal and took advil.
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| 65 | 2021-01-21 | impaired work ability |
Flu like symptoms Major chills could not get warm Fatigue had to leave work No fever Headache Resolv...
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Flu like symptoms Major chills could not get warm Fatigue had to leave work No fever Headache Resolved by 11:00am 01/22/2020 No adverse events with first dose
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| 65 | 2021-01-26 | feeling abnormal |
When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would...
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When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would need to wait 15-30 minutes after the injection. I checked with doctor re: this warning and she felt the vaccine was still beneficial but to do my research and make a decision. I received the vaccine at the Center. I sat down as instructed. 5 minutes later, something felt off and I removed my protective visor. A paramedic came over about a minute later and asked if i was ok. I said that i didn't feel well. He said that he was going to get a chair with wheels for me and at that time i must have passed out. The next thing that i remember was waking up laying on the floor. My husband said that there were 4 paramedics in attendance. The primary paramedic was telling me that my BP was 72/60. An ekg was being run, an iv inserted and run full force. they checked my blood sugar which was fine. The primary paramedic kept talking to me to check my level of consciousness. I was there for quite a while. Not sure who the paramedics checked with, but they decided that i needed to go via ambulance to the hospital. The paramedics were very concerned that the ambulance go to the back door to pick me up so others getting the vaccine would not be frightened. I was transported to Medical Center for further evaluation. I was there for a few hours and my labwork was normal. EKG and chest xray were completed as well as cardiac monitoring. I called doctor's office the next morning to notify her of the event. It was very scary!!!
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| 65 | 2021-01-27 | feeling abnormal |
my lower extremities went cold for an instant when they gave the vaccine but it quickly passed. Wait...
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my lower extremities went cold for an instant when they gave the vaccine but it quickly passed. Wait half an hour of post vaccination observation and it went well. On the return car the feeling of cold returned to me in my arms and legs. When I got home I felt good and I prepared something for lunch, when I started eating, around 3.30 pm (about an hour and a half after getting the vaccine) I started to feel bad, my heart was beating very strong and fast, I was gasping for air, dizzy. I used the oximeter and I saw that my heart rate was at 110 and kept going up and the oxygen was going down. I called 911 when the blood pressure monitor and oximeter reached the limit and started flashing, oxygen at 92 and pulses at 141. I thought I was dying. The 911 operator told me to lie down and wait for the paramedics and she stayed with me on the line. I also put ice on my chest. When they arrived my signs began to normalize. I can't quite remember what happened next that day.
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| 65 | 2021-01-27 | nervousness | Chills; Fever; itchy skin; nervousness |
| 65 | 2021-01-28 | excessive sleepiness |
Starting the next night my feet wer freezing when trying to lie down at night, could not get them wa...
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Starting the next night my feet wer freezing when trying to lie down at night, could not get them warm unless wrapped in a blanket which is not normal for me, still ongoing but less intensity today 1-29 Ongoing fatigue and having to nap daily and if working go home and going to be early and sleeping about 10-11 hours a night, again not normal Improving daily but still ongoing
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| 65 | 2021-01-30 | sleep disorder |
"Pfizer-BioNTech Covid-19 Vaccine EUA Six days after after I received the second dose of the vaccine...
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"Pfizer-BioNTech Covid-19 Vaccine EUA Six days after after I received the second dose of the vaccine I started having a right hip pain. The next day, I started having constant low back pain, bilateral hip pain, left shoulder pain and pain below both thumbs. Aleve relieved the pains only for 6 hours and then start again. My sleep was so disrupted for 7 days. I finally say Dr. on 1/19/2021
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| 65 | 2021-01-31 | sensation of foreign body |
Lump/swelling in throat no problem breathing or eating Started immediately after the vaccine was adm...
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Lump/swelling in throat no problem breathing or eating Started immediately after the vaccine was administered thought it was my nerves but it hasn't gone away it's a day later
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| 65 | 2021-02-01 | fear |
hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in h...
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hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-02-01 | feeling abnormal |
Client c/o flush that washed over her while waiting 15 minutes. Also stated tachycardia and "skippe...
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Client c/o flush that washed over her while waiting 15 minutes. Also stated tachycardia and "skipped heart beats." She stated that the skipped beats started about a week after her first dose of Pfizer. BP 128/82, pulse 88 with 1 skipped beat every 1-2 minutes by palpation. She refused EMS, went home in car after 50 minutes. At 4:15 p.m. called after another episode of flushing and tachycardia, feeling "weird." Went to urgent care and had EKG, normal compared to one 2 years ago. NP and a consulting doctor diagnosed vaccine reaction, advised fluids and rest. BP and pulse continue to fluctuate. Per client, 2/2/21 a.m. her pulse goes from 80-112. She will continue to monitor.
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| 65 | 2021-02-01 | feeling abnormal | pt being to feel uneasy, and mouth tingling. No medications given resolved over 40 minutes |
| 65 | 2021-02-02 | feeling abnormal |
nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all l...
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nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all lasting 3 days
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| 65 | 2021-02-02 | sleep disorder |
16 hours: awakened at 1:30am with joint pain; 19 hours 99.4 temp; 26 hours: 100.5 temp and chills co...
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16 hours: awakened at 1:30am with joint pain; 19 hours 99.4 temp; 26 hours: 100.5 temp and chills continuing through day and night; 34 hours: 102 temp, fatigue; 40.5 hours: awakened with severe headache, fever continues; 46 hours (7am) sweating for about 10 minutes and then all symptoms were completely gone. I took Tylenol or Advil every 4-5 hours. The fever never went down even after taking the Tylenol.
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| 65 | 2021-02-03 | sensation of foreign body, anxiety |
severe ringing in ears; Lump feeling in throat/something was in her throat; throat swelling; Anxiety...
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severe ringing in ears; Lump feeling in throat/something was in her throat; throat swelling; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 16Jan2021 11:30 at a single dose as the patient is a counselor, essential worker, in the health field but she got in because of age (COVID-19 immunization). Medical history included Subclinical hypothyroid (she takes no meds. Was diagnosed 10 years ago), allergies to Sulfa drug, seasonal allergies and sprained wrist. A couple antibiotics bother her stomach but she was not allergic. The patient was not pregnant at the time of vaccination. Concomitant medications included estradiol, B12, calcium and glucosamine. Other medications included estrogen, vitamins, glucosamine supplements, and takes a cream for injury: sprained wrist, she doesn't know the name of it, it is an anti-inflammatory cream, she doesn't think any of that will do anything. No other vaccine in four weeks. The patient had the vaccine on 16Jan2021 Saturday and within 15 minutes (also reported as 20 minutes after shot and at 12:00), the patient experienced severe ringing in ears. She had severe ringing in her ears, it was really loud, and was still there. She can't seem to figure out if it was normal, what's causing it and could it be from the vaccine. It may have been anxiety because of that, but right after she heard ringing, there was a lump feeling in her throat on same day, like something was in her throat, she thought she had throat swelling, it lasted a couple of days, but she had no shortness of breath or anything. Ringing in ears was a lot worse in the morning, and gets better during the day, maybe because she was around noise, but it comes and goes, there are two separate sounds, one was a high pitched and continuous, the other one was lower pitched, a little fragmented, if she drew a picture, there would be little dust particles in the air, but the other is constant, she tried really hard to ignore, but it was driving her nuts. She is hoping it will go away. The lump feeling in her throat was gone, she was wondering if it was anxiety. It was mentioned, "She gets nervous, gets a lump in her throat a lot", but this was really severe, but she saw a man being taken away in an ambulance, and that scared her, she was waiting in the waiting area, and saw that, so it scared her. Recovered completely from the lump feeling in her throat. Throat was normal in 2 days but ears ringing still there after 4 days. There was no treatment for the events severe ringing in ears and Lump feeling in throat. The outcome of the events severe ringing in ears was not recovered; event Lump feeling in throat and throat swelling was recovered in 18Jan2021; and unknown outcome for the other event. Information on lot/batch number has been requested.
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| 65 | 2021-02-04 | feeling abnormal |
On 01/26/2021 I received my second dose of COVID vaccine. 02/04/2021 I awoke at 3am and could see ...
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On 01/26/2021 I received my second dose of COVID vaccine. 02/04/2021 I awoke at 3am and could see fine. At 7am I awoke again and was seeing double from my left eye. Was seen my an ophthalmologist and dx w 4th nerve palsy- Left eye. I have no underlying medical conditions to explain this, ie no diabetes, HTN etc.. At this time 02//05/2021 I continue to have double vision , the image is sloping downward, head movement and keeping my left eye open results in this woozy feeling of imbalance and nausea.
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| 65 | 2021-02-04 | insomnia |
At 11:30 pm, I experienced body aches ( neck, back, legs, and head) and insomnia. 3:00 am I took Ad...
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At 11:30 pm, I experienced body aches ( neck, back, legs, and head) and insomnia. 3:00 am I took Advil. Woke up a bit better. Just headache remained. Totally exhausted though. Took 2 naps. Went to sleep at 9:30 pm-6:00, second night. Today, day 3, so far so good
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| 65 | 2021-02-05 | feeling abnormal |
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv...
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Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
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| 65 | 2021-02-05 | sleep disorder |
Vertigo starting in the middle of the night after vaccination. One incident while walking the next ...
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Vertigo starting in the middle of the night after vaccination. One incident while walking the next day. Vertigo when turning over in bed- none while standing or walking.
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| 65 | 2021-02-06 | sleep disorder |
I previously reported immediate symptoms - I STILL have ringing/buzzing in the ears, to the point th...
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I previously reported immediate symptoms - I STILL have ringing/buzzing in the ears, to the point that I cannot get sleep.
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| 65 | 2021-02-08 | impaired work ability |
I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horr...
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I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horrible body pain. No temp. I missed 6 days of work I was so sick.
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| 65 | 2021-02-08 | mental status changes |
Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hosp...
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Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hospital. Post dose she experienced intermittent sensation of tingling on left posterior neck area with no paresthesia and difficulty lifting bilateral extremities. Three days after administration of the vaccine she began noticing weakness in her legs that eventually progressed to her arms bilaterally. She developed pitting edema and SOB. Per infectious disease MD, the main suspicion is for GBS Guillain-Barre Syndrome given exam findings. Pt's weakness and resulting inability to ambulate may have pushed pt into CHF exacerbation. Patient received 3 days of IVIG which was discontinued due to worsening mental status. Naranjo scale score of 2 indicates possible ADR.
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| 65 | 2021-02-08 | nervousness, feeling abnormal |
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energ...
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She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
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| 65 | 2021-02-09 | depressed mood, feeling abnormal, irritability |
feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed;...
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feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
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| 65 | 2021-02-14 | anxiety |
Hx of anxiety. Became anxious, legs shaking and felt like her throat was closing immediately after g...
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Hx of anxiety. Became anxious, legs shaking and felt like her throat was closing immediately after getting the vaccine. Pulse ox originally 91% on RA but improved to 95% on 2L. Patient fully recovered after 30 minutes with no medications.
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| 65 | 2021-02-14 | sleep disorder |
Injection site soreness; headache (front of forehead across top of head all the way back to ears); s...
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Injection site soreness; headache (front of forehead across top of head all the way back to ears); sinus ache under eyes; muscle ache across shoulders; hint of nausea; early morning awoke to profuse sweating; tired.
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| 65 | 2021-02-15 | loss of personal independence in daily activities |
Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, uppe...
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Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, upper body shoulders to wrists aching. Weakness of upper extremities. 2\16\2021 generalized weakness fatigue,Felt cold, discomfort to skin during shower from water pressure. Difficult getting dressed/ stiffness. Tylenol 500mg q6 hrs and rest all day TX. Feeling better by 4 pm
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| 65 | 2021-02-15 | sleep disorder |
She was eating after the vaccine which started as a stiffness, down both of her shoulders and into h...
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She was eating after the vaccine which started as a stiffness, down both of her shoulders and into her waist, severe nauea and headache. She felt like her feet were in cinderblocks. She took some Tylenol, and woke up at 4:00 AM and had two severe headaches and nausea since Sunday. That night she felt as though she could not stand it any longer. Went to UC and they tested her for the virus which was negative, and still having symptoms. She thought the symptoms would get less, but it has been quite a few days. She takes a short walk and the intense pain in her arms, and legs are terrible. Her PCP told her that there was nothing they could do, and what she had been doing what she needed to do. They also told her to go back to UC if she did not improve.
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| 65 | 2021-02-16 | anxiety |
S/p vaccination at 1110 at 1120 c/o dizziness , hx of acute anaphylaxis, able to walk to stretcher w...
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S/p vaccination at 1110 at 1120 c/o dizziness , hx of acute anaphylaxis, able to walk to stretcher with use of cane. Responses verbally . Vitals signs abnormal to patient: @1135 137/68 HR 83 sp02 99%, @1140 BP 137/68 HR 80 sp02 98%, @1145 pt remains c/o dizziness. pt verbalized she was 'anxious' because her doctor wanted her to get the vaccine. BP increased slightly 160/79 HR 85 sp02 99%. @1149 RRT was called. Vitals taken @ 1150 BP 157/79 HR 81 sp02 99% . RRT arrived at 1155. Pt able to stand but was slightly unbalanced and was safely transferred to wheelchair and was transported to ED by RRT.
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| 65 | 2021-02-16 | sleep disorder |
About 10 hours after vaccination a headache started. Then my joints started hurting almost like a ne...
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About 10 hours after vaccination a headache started. Then my joints started hurting almost like a nerve was firing off but only at the joints, ie knee, shoulder, toes, ankle, fingers, toes, etc. It would happen randomly. Never all joints at once. Very weird. Continued throughout the night making it difficult to sleep. In the morning, at 7 am, got up out of bed. Took 2 Advil. At 10:20 I still have the joint happening but not as frequent and not as strong. I still have the headache. It hasn't changed.
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| 65 | 2021-02-17 | nervousness, sleep disorder |
trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feelin...
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trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feeling very shaky and very weak; feeling unwell; alternating slow heartbeat and fast heartbeat; a weird feeling in her head like pressure but not a headache/pressure feeling in my head; they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction.; This is a spontaneous report from a contactable consumer. A 65 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergic to shrimp, lupus anticoagulant syndrome, chronic kidney disease and antiphospholipid syndrome. Concomitant medications included amlodipine, HCTZ, losartan, acetylsalicylic acid (ASPIRIN (E.C.) and atorvastatin calcium (LIPITOR ORIFARM). The patient informed that immediately after receiving the injection she felt a lump in her throat and could not swallow, still present now. Patient also informed that after vaccination she was having a very high blood pressures, feeling very shaky and very weak, a weird feeling in her head like pressure but not a headache, trouble sleeping because of the pressure feeling in my head, feeling unwell and alternating slow heartbeat and fast heartbeat. Patient also reported she had scheduled an allergist appointment and they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction. At the time of the reporting event outcome was unknown.
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| 65 | 2021-02-18 | feeling abnormal, anxiety |
As RN was rounding patient was c/o ?dizziness and wooziness? and stated she has been feeling this wa...
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As RN was rounding patient was c/o ?dizziness and wooziness? and stated she has been feeling this way since vaccinated. Also says she had a ?buzzing sensation in her head? when she initially sat down in observation area. Patient reported feeling anxious; initial vital signs at 1334- SpO2-96%, pulse-78, BP 150/86, dizziness 5/10. Repeat vital signs at 1405- SpO2 96%, Pulse-68, BP 132/80, dizziness 1/10. Patient offered water and orally hydrated. After 15 minutes of therapeutic conversation, patient states that she ?feels fine? and dizziness has resolved. Patient educated on need to seek medical treatment with emergent symptoms after leaving facility- patient verbalized understanding.
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| 65 | 2021-02-18 | feeling abnormal |
Started feeling bad, throat started hurting, lost voice. Still am unable to talk very well and has ...
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Started feeling bad, throat started hurting, lost voice. Still am unable to talk very well and has been going on for 4 weeks.
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| 65 | 2021-02-18 | sensation of foreign body |
About 3 minutes after receiving the vaccine, the patient reported feeling dizzy and as if she had a ...
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About 3 minutes after receiving the vaccine, the patient reported feeling dizzy and as if she had a lump in her throat. She did not have trouble breathing or swallowing and no itchiness or rash. The patient was given Benadryl and Zyrtec. She continued to be slightly dizzy and was taken to the emergency department for monitoring. Workup in the ED was negative. The patient was discharged home.
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| 65 | 2021-02-18 | sleep disorder, abnormal dreams |
Tasted vaccine within minutes of dose. Within 15 minutes had itching of face and forearms which las...
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Tasted vaccine within minutes of dose. Within 15 minutes had itching of face and forearms which lasted about 8 hours. For 2 nights, but especially the first night, had vivid dreams and woke up every 2 hours. Had some minor fatigue day after shot. All resolved by themselves. Was totally back to normal after 2nd nights sleep.
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| 65 | 2021-02-18 | sleep disorder |
Severe to VERY severe continuous lymph node/breast pain on shot side 1/27 through 2/4. Starting 2/4...
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Severe to VERY severe continuous lymph node/breast pain on shot side 1/27 through 2/4. Starting 2/4 intensity started to vary i.e no pain during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On night of 2/3 spread to back ? shot side line of nodes paralleling spine and shoulder/neck area- back pain not as severe as original breast area and heat helps to reduce back pain Pain interferes with sleep - 2/4 finally able to get 4 hours sleep ( hot shower temporary relief while showering)( normal is 7 hrs) As of 2/5 still in moderate to severe breast area pain almost continuously. Hope I am recovering but its 10 days and still mostly constant incapacitating pain. Very slight intermittent node pain by Feb 17 when got second shot in other arm per Physician Assistant?s recommendation. So far after 51 hours 2nd shot adverse effects minimal and does not interfere with thinking or sleeping
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| 65 | 2021-02-18 | sleep disorder |
1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head whic...
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1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head which then continued to a pain in my neck. also left side, then back pain, then slightly short of breath. I remained in the waiting area for over a half hour and felt no worse, but did report it to the young woman at the exit who said that was odd and seemed the kind of response with the second dose. I presumed it might be due to my already having antibodies. As I continued my day those symptoms quickly dispersed and I felt fine, albeit with a light soreness at the site on my left arm. At approximately 6pm I felt very fatigued and rested until 10pm, when I began to have chills, a headache and nausea. My left arm was also so sore I could not lay comfortably. I took Tylenol and aspirin both at 11:30 pm and attempted to sleep, which was fitful and disturbing. I had strange neurological events, such as odd visions in my half sleep and bizarre semi dreams but could not waken. At 4:00 AM I finally was able to pull out of this state and the last thing in my mind was a conversation with someone trying to explain what was happening to me, in my mind not vocal, that was in Italian. That is my second language. All day I had unwanted words, ideas etc. floating about in my brain. I could no longer sleep and was very weak, had terrible head and body aches and my legs also ached terribly. I was also slightly nauseous.These were all symptoms, minus the disturbing neurological one, that I had with Covid. I was too weak to leave the bed until much later in the day. I am still having effects but much less and I am at the 72 hour mark. I remained at rest all day and ran a low fever, then again a fever
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| 65 | 2021-02-20 | agitation |
Difficulty breathing, compulsive dry cough, felt tight and constricted in upper chest and airway, to...
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Difficulty breathing, compulsive dry cough, felt tight and constricted in upper chest and airway, tongue felt thick and mouth has strange taste, vision blurry, after half an hour also a lot of burping and fingertips felt numb. After an hour and a half, nurses took blood pressure and was very high, plus slightly elevated heart rate. Clinic called EMT who took blood pressure, was 180/110. My normal BP is around 130/75. Heart rate around 95 (normally 65). I declined going to emergency room because I could breath, even though it was agitated and coughing a lot. I did not want to go where there might be a lot of sick people.
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| 65 | 2021-02-21 | anxiety |
Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and...
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Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and got up to go to the bathroom but felt fine. Went out to the hall bathroom so as not to wake husband in Master bath. Urinited and got up slowly as I always do and walked out to the hallway to go back to bed. I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing. I have no recollection of it once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway. I didn't feel any pain. Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet with sweat and I took a couple minutes to come to. After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills. No fever. Slept most of the next day and night. Headache and joint aches and swelled lymph nodes in neck.. Fatigue through 20th. Mostly better by the 21st. Still today on 22 I am being careful when going from prone to standing. I feel more head pressure getting up and maybe I notice a little nausea when rising. I may just be worried about fainting again. It has never happened to me before. I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted. Neck is sore.. Not sure if lymph nodes or something to do with fall.
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| 65 | 2021-02-21 | feeling abnormal |
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a...
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I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
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| 65 | 2021-02-21 | insomnia |
Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even ...
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Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached, difficulty walking.
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| 65 | 2021-02-21 | insomnia |
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness...
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all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
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| 65 | 2021-02-21 | panic attack, feeling abnormal |
Pt states she is not feeling normal after getting her second dose of the vaccine. Pt does not have a...
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Pt states she is not feeling normal after getting her second dose of the vaccine. Pt does not have any rashes, hives, swelling, difficulty breathing. Pt states she has a history of anxiety and believes she is having a panic attack. Pt's vitals are stable. Pt sat and talked with EMS for 10 minutes. Pt states she is feeling better and would like to leave. Pt did not require transport to hospital.
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| 65 | 2021-02-21 | sleep disorder, restlessness |
sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread th...
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sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; she was up all night and couldn't sleep/ restless, had trouble getting sleep, had trouble getting in a comfortable position/ woke up frequently; restless, had trouble getting sleep, had trouble getting in a comfortable position, and woke up frequently.; tightness in her left leg; weird sensations in her legs/ sensations moved to her arms; Ongoing Restasis for Sjogren's syndrome; Ongoing Restasis for Sjogren's syndrome; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: L9261) via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included ongoing Sjogren's syndrome from 2015 (sees her Rheumatologist/ do blood work once a year to make sure her inflammation levels are okay), ongoing rosacea; dry eye syndrome (related to Sjogren's syndrome); spasming, burning and twitching (last 2 medications she was on in November and January she had similar type reactions in her muscles); arthritis flareup from Oct2019 (in her left leg, she saw her neurologist who did tests and they came back normal) and sinus infection in 2020. Ongoing concomitant medication included ciclosporin (RESTASIS) for Sjogren's syndrome, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for blood test: deficient and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) for dry eye syndrome related to Sjogren's syndrome. The patient previously took prednisone from Nov2020 and experienced weirdness in her legs got strong enough to keep her up at night and bad flare up for her leg symptoms; metronidazole for flare up or Rosacea (0.75% as needed, which she has used daily for last few weeks), meloxicam in Nov2020 and pantoprazole in Jan2021 and had bad flare up for her leg symptoms (symptoms subsided as soon as she stopped taking the medication after about 5 days); ibuprofen, acetaminophen and pepcid for her stomach. She had the vaccine, her first dose, on 27Jan2021, about a week ago. The first two days she didn't notice anything and then she had weird sensations in her legs on 28Jan2021. The second night she had a weird sensation in her legs which was similar to what she had experienced with the two medications she took in November and January. On 30Jan2021 the sensations spread through her body, she describes these sensations as twitching, burning, cramping, and tingling. She clarifies the sensations moved to her arms which did not happen with the other medications that she tried in November and January. Monday night, 01Feb2021, she was up all night and couldn't sleep and says she called the family doctor yesterday and he called in a prescription for Gabapentin 100 mg. She said she took the medication last night and she did sleep last night, but she was unsure if it was from exhaustion from the last few nights from not sleeping or the medicine, but she did sleep better and her symptoms were a lot less last night. Patient said she wanted to report this and that her concern is with the second dose; will she have a worse reaction, is there anything she can do or take and should she be concerned about it. She said the events gradually increased, they started mildly and then became significant. She felt the sensations a little bit in the day time but they start big time in the night when laying down. These sensations experienced in her legs started the second night, 28Jan2021, and then spread to her arms in the last couple of days which had not happened with her other incidences (with the medications mentioned above back in November and January). Clarified that the sensations spread to her arms on 29Jan2021, but the worst nights were 31Jan2021 and 01Feb2021. She said they were bad nights. She said in regard to her sleeping, starting on 29Jan2021, she was restless, she had trouble getting sleep and trouble getting in a comfortable position. She woke up frequently. Saturday the sleeping was a little worse, but she did sleep. She said on Sunday, 31Jan2021, and Monday, 01Feb2021, she hardly got any sleep. The sensations spread to her arms and it probably started a little on Saturday night, but Sunday and Monday it was very noticeable. She started Gabapentin; it was one a day before bed. The leg symptoms were still there last night. The sensations in her arms were not much at all. She did get up once with the leg cramp and was feeling tightness in her left leg but it never went into a cramp. The cramp was in her right leg, which was unusual because it was usually in her left leg. She stated she was unsure if her symptoms were starting to subside or if the Gabapentin had an immediate effect. The events did not require a visit to physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
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| 65 | 2021-02-23 | sleep disorder |
Severe frontal sinus headache that started around 5 pm. No relief with Extra Str. Tylenol. Pain so s...
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Severe frontal sinus headache that started around 5 pm. No relief with Extra Str. Tylenol. Pain so severe, I could not sleep all night. Had telehealth visit on 1/12/2021 and APN recommended I take 1000 mg. Tylenol and 600 mg Ibuprofen at the same time and to rest and to repeat these medications in 6 hours. Headache resolved after 2nd dose of medications. Since that episode, I continue to have intermittent frontal sinus headaches, not as severe as the first one.
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| 65 | 2021-02-24 | feeling abnormal |
She did not have any reactions initially, but noticed the morning after the vaccine that her regular...
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She did not have any reactions initially, but noticed the morning after the vaccine that her regular cup of coffee did not taste good. She then had a rash that started on the left side of her neck, went towards the back now. This started a few days after the vaccine, all on the left side. She also got a cold sore on her lip which she had all the time as a child, but not as an adult, which has pretty much resolved. She has been cold, chills and some dizzy spells. She did get a bump on her head concussion in December. One day last week she just stayed on the sofa with a blanket due to feeling poorly. 3 days ago on her back by her shoulder blade an area has been really sore. She did take some Tylenol for the back pain which did not help so she stopped this. She did not call her doctor. The rash is still there but not as intense. It has not itched, but she has felt it.
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| 65 | 2021-02-24 | impaired work ability, sleep disorder |
Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, ...
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Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, worsening, nauseas . Went home from work that evening around 9:30 p.m. I Vomited as soon as I got home. Felt better but still lightheaded, dizzy, not as bad. No fever. Couldn't sleep. Tuesday, February 23 felt pretty weak, tired some lingering lightheadedness. Stayed home from work. Next day, Wednesday, my right arm around the injection site was pretty sore. Hard to sleep last night. Took Tylenol for arm. Still somewhat sore today, Thursday.
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| 65 | 2021-02-24 | insomnia |
Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired...
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Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired. started about an hour later. Did not sleep well. Stayed in bed the next 2 days. Tightness in chest went away the second day. Third day I felt like myself. These were things that I also experienced with Covid.
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| 65 | 2021-02-27 | impaired work ability |
1. Pain on the injection site (left arm) for 36 hours. I was able to move the arm, there was no swel...
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1. Pain on the injection site (left arm) for 36 hours. I was able to move the arm, there was no swelling. 2. Wrist pain on the left hand, with any movement for 36 hours. I do not have carpal tunnel syndrome. I was not able to do any work because of the pain on one side of the wrist. Pain went away after the second night.
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| 65 | 2021-02-28 | anxiety |
Client c/o chest tightness. Client states I am having a hard time breathing. Client seen by EMS. ...
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Client c/o chest tightness. Client states I am having a hard time breathing. Client seen by EMS. Vitals: B/P 133/85, HR 88, Client verbalized that she had been anxious about receiving vaccine and that she is now able to breathe now that it's over and was cleared to go home by EMS.
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| 65 | 2021-03-01 | agitation, anxiety |
Woke up 48 hours after injection with itchy palms(hives) and both lips burning. Very anxious and agi...
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Woke up 48 hours after injection with itchy palms(hives) and both lips burning. Very anxious and agitated, light headed. History of anaphylactic results requiring medical intervention in the past. Drank a lot of water and took a Zyrtec then laid down and slept 2-3 hours. Exhausted for over a week.
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| 65 | 2021-03-01 | anxiety, mental status changes, confusional state |
2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the or...
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2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 °C (98.6 °F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. Electronically signed by RN at 02/09/2021 9:32 AM CST Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. Electronically signed at 02/09/2021 9:17 AM CST 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me "I'm ok" before closing her eyes again. She is satting well on nasal canula oxygen.
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| 65 | 2021-03-02 | anxiety |
Patient reported that her heart is racing. I checked her BP three times: 12:37pm 168/98 pulse 97 12...
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Patient reported that her heart is racing. I checked her BP three times: 12:37pm 168/98 pulse 97 12:46pm 157/96 pulse 89 12:58pm 147/93 pulse 86 Patient said she felt anxious due to her allergy history. I had her sit in the observation area for 30 minutes and gave her water. She displayed no additional symptoms and nothing that would have been indicative of anaphylaxis. She was vaccinated at 12:30pm and left the store with her husband at 1pm.
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| 65 | 2021-03-02 | feeling abnormal |
About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensati...
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About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensation move up into my right side of face. Swelling on right side was noticeable for two days. Mild numbness also occurred that went away as swelling subsided. However on 3/3/21 I am noticing numbness in upper lip and jaw... also mild.
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| 65 | 2021-03-02 | sleep disorder |
Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, sta...
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Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, started going downhill with chills and some sneezing. Managed to get to sleep, but woke up at 1:15 am and could not get back to sleep. Feeling chilled all night. At 5:30 am, got out of bed to take Tylenol and experienced dizziness (briefly blacked-out), sweats, nausea (vomited) and slight diarrhea. After that episode, started to feel a little better, though still a bit woozy and exhausted from lack of sleep.
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| 65 | 2021-03-04 | insomnia |
Since 2nd shot on 2/15/2021 I have been experiencing worsening sleeplessness. First it wasn't every...
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Since 2nd shot on 2/15/2021 I have been experiencing worsening sleeplessness. First it wasn't every night. For the 5 nights I had one night I actually slept well - I took Lunesta. Last night I tried 3mg melatonin- fell asleep but woke up after 2 hrs, read for 3, then "twiliight slept" , maybe actually dosing off a little. This is very unusual for me. What can I do ? Will my normal routine return?
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| 65 | 2021-03-05 | anxiety, nervousness |
Patient complained of "anxiousness" and "nervousness" after receiving vaccine. Patient assessed by E...
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Patient complained of "anxiousness" and "nervousness" after receiving vaccine. Patient assessed by EMS on site. HR-99, SPO2 97% on RA, no rash or hives. Pt anxiety resolved after 25 minutes without treatment.
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| 65 | 2021-03-07 | feeling abnormal | Very foggy headed x3 days |
| 65 | 2021-03-07 | memory impairment, disorientation |
High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these hap...
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High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.
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| 65 | 2021-03-07 | nightmare |
slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, mi...
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slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, minor sweating. on Sunday began nausea, headache, neck and shoulder aches, fluish, minor sore throat. knew I would sleep heavily again and did.
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| 65 | 2021-03-08 | feeling abnormal |
Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. ...
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Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. Started to black out and went down but not unconscious. Then bowel movement and nausea at same time and started dripping sweat profusely. Soaked my clothes. So weak could not get up or felt as though will pass out. Then got the chills and loud ringing in my ears. Whole episode lasted about 20-30 minutes then went to bed at 7:30 p.m. felt so exhausted and fatigued. Woke up about 4a.m. arm hurt but felt okay. Little off balance, fatigued, weak all day. Next day arm sore but improving. Now fine. Saw doctor today, he advised me to report and wait to see advice from Pfizer as to get2d dose or not.
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| 65 | 2021-03-08 | feeling abnormal |
Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and...
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Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and felt very bad. Was taking Tylenol every 4-6 hours but headache continued to get worse throughout the evening and into the night 3/4-3/5/21. Left arm began hurting too on 3/4/21 but no swelling or redness, just sore. Finally began feeling a little better by late evening on 3/5/21 and headache was beginning to ease but did not fully go away until 3/6/21. Was able to manage the side effects at home without going to my Dr.
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| 65 | 2021-03-08 | mental impairment |
Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness,...
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Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness, headache, loss of appetite, dizziness.rash and itchiness of arm.
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| 65 | 2021-03-09 | anxiety |
Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 3/3/2021 Subjective Pt. is a 65 y.o...
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Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 3/3/2021 Subjective Pt. is a 65 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. Past Medical History: Diagnosis Date ? Belching ? Bloating ? Chicken pox ? Cold sensation of skin ? Diarrhea ? Ear pain ? Generalized headaches ? German measles ? Graves disease ? Measles ? Mumps ? PVC (premature ventricular contraction) ? Sinusitis ? Thyrotoxicosis without mention of goiter or other cause, without mention of thyrotoxic crisis or storm Hyperthyroidism; ? Type II or unspecified type diabetes mellitus with unspecified complication, not stated as uncontrolled (HCC) DM Type II with comp; ? Unspecified essential hypertension Hypertension; ? Varicella without mention of complication Chicken Pox; ALLERGY REVIEW OF SYSTEMS: Patient complains of sore throat, frequent throat clearing and headaches (states she was outside yesterday and developed a headache/sinus headache. She has not taken anything for it.) Patient denies chills, fever and malaise/fatigue Previous Reactions: hx of reaction to tetanus. Reaction was arm swelling and throat swelling per pt. She did not take any medications I.e. anti-histamines prior to coming. She has throat clearing, states this is chronic, unchanged. She reports that she isn't sure if this is allergic or anxiety. Objective Vitals Vitals: 03/03/21 0940 03/03/21 0945 BP: (!) 190/71 (!) 167/76 Pulse: 86 SpO2: 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious (slightly anxious). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water pepcid and zyrtec Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash). HTN More likely anxiety related in her reaction today. No progression of her symptoms of throat tightness. She reports it is resolving. Time of observation was 30 minutes. She feels comfortable going home. She is aware of what to monitor for. IN regards to her elevated bp, pt states she was off her medications for a while and working on diet. She is stable w/o cp, sob, jaw pain, neuro deficits, lightheadedness, dizziness. Recommend she monitor her bp at home and if continues to be elevated >140/90 that she follow up with her pcp. She also is aware of hypertensive emergency and to go to ED if needed. She is stable and looks well on discharge. Pt is comfortable going home. She ambulated w/o difficulty and complaints. Pt also was offered tylenol here in the bay for her sinus headache that she developed yesterday after being outside. She declined. She reports she will take at home and resume her nasacort as usual. Electronically Signed 3/3/2021 9:50 AM 3 of 3
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| 65 | 2021-03-09 | anxiety |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 5:11 PM Ex...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 5:11 PM Expand AllCollapse All COVID VACCINE CLINIC 3/4/2021 Patient: Date: 3/4/2021 MRN: 9302775 Subjective Patient is a 65 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis Date ? Anemia, unspecified ? Excessive or frequent menstruation ? Other and unspecified hyperlipidemia ? Pure hypercholesterolemia ANXIETY, claustophobia ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, joint pain, dizziness and headaches + lightheaded: Previous Reactions: none Objective Vitals Vitals: 03/04/21 1200 BP: 122/74 Pulse: 87 Resp: 16 SpO2: 98% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Speech: Speech is rapid and pressured (able to calm down by time she was in the bay and observed.). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Observed for 15 minutes in the bay. Pt appreciated her visit today. She more likely had an anxious moment as she reports she was anxious coming in. VS and exam stable/improved. Pt to follow up with pcp as needed. APRN Electronically Signed 3/4/2021 12:07 PM
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| 65 | 2021-03-09 | feeling abnormal |
jitteriness; Sore arm; brain fog; loss of some exercise ability; This is a spontaneous report from a...
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jitteriness; Sore arm; brain fog; loss of some exercise ability; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 01Feb2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient medical history was not reported. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication/other medications given within two weeks included 'Metropol.' There was no other vaccine given to the patient within four weeks. On 01Feb2021 12:00, the patient experienced sore arm, first day brain fog and loss of some exercise ability. The patient also experienced jitteriness two days after (03Feb2021). No treatment given for the adverse events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Feb2021. Information about lot/batch number has been requested.
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| 65 | 2021-03-09 | sleep disorder |
Starting with my first dose on 2/5/21 my psoriasis and psoriatic arthritis (worsened. After my seco...
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Starting with my first dose on 2/5/21 my psoriasis and psoriatic arthritis (worsened. After my second dose I had chills, lethargy and severe joint and body pain (difficult to sleep) which improved after 36 hours--except worsening of left knee pain--by 3/5/21 I was unable to stand, walk or move my left knee due to pain. I self treated with Naprosyn (400 mg bid) and went to urgent care on 3/6/21. The XRAY was negative with slight effusion. I have had no injuries or trauma to my leg. I am a physician and have had psoriasis and PsA for about 25 years--have on and off medical care (topical steriods, creams and NSAIDS). Due to my +BRCA2 gene I have not taken stronger immuno-suppressive therapies.
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| 65 | 2021-03-10 | nervousness |
Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold insi...
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Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold inside, shaking inside
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| 65 | 2021-03-10 | sleep disorder |
12 hrs. after 1st vaccine, woke up with body aches and headache, feeling like I had the flu. This a...
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12 hrs. after 1st vaccine, woke up with body aches and headache, feeling like I had the flu. This all passed after 3 hrs. 13 hrs. after 2nd vaccine, woke up at 4:00 a.m., with sever body aches all over, slight fever, headache, severe tiredness, and general feeling sick, like I had the flu. Took Tylenol, went back to bed, and slept 24 hrs,, then woke up feeling somewhat like I had a hangover, but as the day progressed, felt back to normal. Small price to pay to get vaccinated!!!!
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| 65 | 2021-03-11 | impaired work ability |
Dizzines/vertigo. Continue to feel unsteady. Increased sensitivity to computer work, ongoing. Incr...
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Dizzines/vertigo. Continue to feel unsteady. Increased sensitivity to computer work, ongoing. Increased sense of overwhelm with normal activities. I am a mental health provider. I have had to cancel clients all week due to symptoms.
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| 65 | 2021-03-11 | sleep disorder |
Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensit...
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Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensitivity. I have migraine disease but since I began Aimovig injections nearly a year ago I have very few migraines, Those I have had have been extremely mild, just headache usually relieved by otc meds. Additionally I have not had nausea and vomiting with any migraine episode for many years. When I woke at yesterday morning, I was in extreme pain across the right side and back of my head and down to my neck and shoulders. 9 out 10. I took my prescription, Eletriptan .5 mg at 5:45 and went back to bed. It gave little relief of symptoms. I was unable to sleep and at about 7 a.m. I was hit with waves of nausea and extreme violent vomiting. This last for several minutes. At approximately 9 a.m. I took a 2nd dose of Eletriptan and slept a little. Again at about 11: a.m. I was hit with another round of extreme nausea and vomiting which lasted about 5-6 minutes. I slept a bit and around 3 p.m. was finally able to drink a little water. Still very weak but pain had subsided significantly, down to about a 4 / 10. By 6 pm. I was almost pain free ? symptom free though very weak still. Ate a little at about 7 p.m. I know this was a migraine which I am diagnosed with but it was extreme even for me, and especially in recent years. It was very unusual in timing and severity and I felt it needed reporting.
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| 65 | 2021-03-13 | anxiety, depressed mood, feeling abnormal |
Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I too...
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Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I took Benadryl. 2nd Day, Next morning: headaches. Tylenol. Foggy and not clear headed. L arm hot and hurts, Hip, knee and ankle on L side painful. Very tired. Rash is gone. Mid day: anxiety and feeling down. Called Dr. and got nurse and then called therapist. headache still continues. I took a nap, I never take naps unless very sick. Eve: Rash came back. Benedryl Headache. Tylenol 3rd day: Diarrhea. headache, still foggy and tired.
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| 65 | 2021-03-13 | confusional state, sleep disorder |
The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got naus...
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The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got nausea. Was sent to Urgent Care office where I got EKG, which showed no problems with my heart. Went home, weak. Woke at 2:00 am with night sweats. When I got up I noticed swelling on face, throat, hands & feet. Faint pink rash ran up both fore arms and I had welts rising on my wrists. Nurse line I called said to to to ER asap, Took me a few hours to find a ride, my throat was closing up more by that point. I could tell over a few hours that my throat was swelling up. Went to nearest ER where I was very mentally confused. They gave me a shot of steroids and Benedryl. Later that night I got chills and was VERY weak. Had night sweats again. After a few days of rest, am still weak.
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| 65 | 2021-03-15 | anxiety |
Client received 2nd dose Pfizer vaccine at Center. 4 hours later at approximately 1:20, client was s...
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Client received 2nd dose Pfizer vaccine at Center. 4 hours later at approximately 1:20, client was shopping at store and started experiencing difficulty breathing, "throat closing." Client went to pharmacy with symptoms. pharmacist administered Benadryl at 1:22 pm and Epi-Pen at 1:23 pm. Ambulance called. Client stated she started feeling better after medication administered. Client declined going to ER via ambulance. Called client 3/16/21 and client reports she thinks she was having anxiety.
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| 65 | 2021-03-15 | feeling abnormal |
Approx. 6 hours after first dose - she developed a funny feeling in her head. This feeling became pr...
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Approx. 6 hours after first dose - she developed a funny feeling in her head. This feeling became profuse sweating, stomach irritability, blacked out and fell to the ground. She had chills and ringing in her ears. symptoms resolved by next morning.
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| 65 | 2021-03-15 | sleep disorder |
Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subs...
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Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving. Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic. Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
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| 65 | 2021-03-17 | mental status changes |
Patient reports shortly after receiving her first Pfizer COVID-19 vaccine on 2/23/21, she developed ...
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Patient reports shortly after receiving her first Pfizer COVID-19 vaccine on 2/23/21, she developed flushing of the face followed by erythema of the body, warmth and tingling. This was accompanied by numbness, a change in her vision and mental alertness. Patient reports similar symptoms occurred in the past when she experienced anaphylactic reactions, such as with bee stings.
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| 65 | 2021-03-18 | feeling abnormal | Weird feeling 30 minutes after vaccine. BPs 147/93 (pulse 76), 122/85 (pulse 73). O2 sats 98%-100%. |
| 65 | 2021-03-18 | feeling abnormal |
Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs...
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Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs, pis and needles sensation toes, slight headache, sore arm
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| 65 | 2021-03-19 | feeling abnormal |
Pfizer-BioNtech COVID-19 Vaccine EUA: 3/16 Left arm was sore at injection site, ached when I moved m...
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Pfizer-BioNtech COVID-19 Vaccine EUA: 3/16 Left arm was sore at injection site, ached when I moved my arm, No Treatment. But, not as sore as it was after 1st injection. 3/17 Day after injection, very tired all day. Went to bed at 7:30pm. Arm soreness waning. No Treatment. 3/18 Noticed slight dizziness, sometimes. Not as tired. Arm pain almost gone, just a bruised feeling at injection site. No Treatment. 3/20 Dizziness more noticeable, today. My head feels like it's full of cotton. No Treatment.
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| 65 | 2021-03-21 | delirium, feeling abnormal |
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec...
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delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
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| 65 | 2021-03-22 | depression |
Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated...
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Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated for a little over a month later. Her BG readings have been improved since then. She also noted to worsening depression, fatigue, arthralgias associated beyond the initial period of the vaccination.
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| 65 | 2021-03-22 | feeling abnormal |
Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain i...
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Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain in neck, chest and shoulder area, headache, chills, fatigue, shortness of breath, heart palpitations, brain fog, malaise. I thought it would pass. Friday I felt no better - by evening I felt swelling in my neck and chest area. Noticeable swelling in clavicle area on both sides. Saturday & Sunday I rode it out until I could see my Dr. on Monday March 22. Dr. gave me a shot of steroids and a script for MethylPREDNISolone - 21 tablets. Today is Tuesday, March 23, 2021 and I feel much, much better. Dr. said to NOT get the 2nd shot and to report this reaction.
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| 65 | 2021-03-22 | sleep disorder |
1. Two hour naps needed for 10 days after shot, now down to an hour. 2. Extremely out of breath -...
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1. Two hour naps needed for 10 days after shot, now down to an hour. 2. Extremely out of breath - from day of shot and continues.
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| 65 | 2021-03-23 | feeling abnormal, impaired work ability |
Felt outside of my body, hazy, not myself, now I am nausous, sweaty, for the last two days (3/21 - ...
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Felt outside of my body, hazy, not myself, now I am nausous, sweaty, for the last two days (3/21 - 3/22) Just feel yucky. Have not gone to work.
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| 65 | 2021-03-25 | anxiety |
Client had an anxiety attack diagnosed and evaluated by MD on site. Client verbalized her BP was inc...
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Client had an anxiety attack diagnosed and evaluated by MD on site. Client verbalized her BP was increased the 1st time she received the COVID19 vaccine in this site was evaluated and was diagnosed with anxiety attack by her primary care physician. She felt very anxious. Vitals were taken 5 times.
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| 65 | 2021-03-25 | disturbance in attention, loss of personal independence in daily activities |
Very deep fatigue. It feels like the life force is drained out of me. I'm not able to function and s...
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Very deep fatigue. It feels like the life force is drained out of me. I'm not able to function and spend most of my time in bed. Sometimes I can sit up on the couch and watch TV. I have trouble concentrating and even talking to someone on the phone is exhausting. My brain is not functioning like it usually does.
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| 65 | 2021-03-28 | feeling abnormal |
then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feelin...
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then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
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| 65 | 2021-03-28 | poor quality sleep |
feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm fe...
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feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm felt mildly painful as injection went in; severe chills; fever; fatigue; restless sleep; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 65-years-old via an unspecified route of administration on 08Mar2021 08:15 (lot number: EN6203) as single dose for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: yes) from 10Jan2021 to an unknown date. There were no known allergies. Concomitant medication included acetaminophen taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 65-years-old, administered on the left arm on 15Feb2021 08:15 (lot number: EL9264) for covid-19 immunisation and experienced very painful injection site, chills, fever and fatigue. The patient reported that when she had her second vaccine on 08Mar2021, her arm felt mildly painful as injection went in, as though never healed from previous shot. This time, within 3 hours of vaccine, she began to feel fatigue, then began to experience chills and fever. She drank plenty of fluids, and took acetaminophen about 6 hrs after injection. In the evening her temp was up to 101.2 (her normal 97.2) and she took Acetaminophen at bedtime. Had very restless sleep, and at 5 AM on 09Mar2021, she got up feeling sick to her stomach ended up fainting onto bathroom floor. Luckily uninjured, and felt better upon "coming to". She was very fatigued rest of day, then normal next day. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Mar2021. No treatment was received for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Linked Report(s) : Same reporter,patient,product/ 2nd dose;US-PFIZER INC-2021269674 Same reporter,patient,product/ 2nd dose
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| 65 | 2021-03-28 | sleep disorder |
severe chills first night- couldn't sleep; lethargy & body aches and sore arm for 24-28 hours; runny...
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severe chills first night- couldn't sleep; lethargy & body aches and sore arm for 24-28 hours; runny nose constantly for about a week; followed by red and very itchy chest, face and scalp about 8 days later.
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| 65 | 2021-03-30 | feeling abnormal |
During the 15 minute wait time , within 10 minutes I got a little dizzy and my tongue began to feel ...
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During the 15 minute wait time , within 10 minutes I got a little dizzy and my tongue began to feel funny. I called over an attendant to ask if I could really be experiencing symptoms and she said yes and asked what I was feeling. She said she would have someone come and check my blood pressure. I told her that I didn't think my blood pressure was the issue it was more that my tongue felt like it was swelling. The swelling did not interfere with my swallowing or talking but i waited another 5 minutes and then I left. I went home and took some Benydryl, ate and signed up for the vSafeTracker app. Within 5 hrs my arm started hurting. The next day I began reporting that my tongue felt swollen and that I realized now that I might have have a bit of a fever. The sensation of swelling I reported daily from 3/12 to 3/16. The swelling sensation went away along with the arm pain, and overall I felt good. The only residual tongue issue I have is a feeling similar to having burned my tongue with a too hot liquid - but it is not the tip of my tongue, but the middle of my tongue even as of today 3/31/21. The
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| 65 | 2021-03-30 | feeling abnormal |
feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous ...
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feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous report from a contactable Consumer (patient herself). A 65-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via left arm on 09Feb2021 11:00, as a single dose for COVID-19 immunization in hospital. Patient's medical history included Multiple myeloma (in remission for the past seven years) and hemochromatosis. Concomitant medication include verapamil and reyvow. On 09Feb2021 12:00, the patient started feeling strange within one hour from receiving the vaccination. As the day progressed, the patient became ill and experienced horrible headache, chills, intestinal issues, tiredness nausea. Patient did not receive any treatment for the adverse event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination was not diagnosed with COVID-19. Since the vaccination patient had not tested for COVID-19. Patient had not allergies to medications, food, other products. The outcome of the events was recovered on 11Feb2021. Information on the lot/batch number has been requested.
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| 65 | 2021-03-30 | hallucination |
hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/n...
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hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
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| 65 | 2021-03-30 | thinking abnormal, confusional state |
Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in ...
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Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in the throat; Headache; Dizzy; couldn't think clearly/her thinking wasn't clear; Confused; sensation in her chest; weak; fatigued; she had a full tongue which effecting her talking; tingling in her lips; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EN6198; Expiration Date: Jun2021), as single dose in left shoulder on 04Mar2021 at noon for COVID-19 immunisation. Medical history included Hashimoto's disease from May2012 and ongoing (autoimmune condition), ongoing undifferentiated connective tissue disease (UCTD) (autoimmune condition, unsure when diagnosed, started with polymyalgia rheumatica, then it went to rheumatoid arthritis (RA), then it went between Lupus and undifferentiated connective tissue disease), hospitalization: she had to go hospital twice in last 4 months, one was for Amlodipine which has polyethylene glycol and another time for Lisinopril as another blood pressure medication, she had 2 mild anaphylactic reactions in the last 4 months from amlodipine and Lisinopril, patient thought they all have PEG in the ingredients; underwent colonoscopy unknown results. There were no concomitant medications. On 04Mar2021 the patient experienced anaphylactic reaction, gasping for air, headache, dizzy, could not think clearly/her thinking was not clear, tongue swelling, swollen lips, throat closing/restriction in her throat, confused , sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips. Course of events was as follows: The patient drove two hours to get the vaccine. The patient was vaccinated on 04Mar2021 at noon. The reaction started immediately, the caller had a severe headache within seconds, a little bit of sensation in her chest. The patient's thoughts were getting mixed up, she was not thinking clearly. This was one of first things that happened. The patient stumbled a little bit and the nurses were there around her and said she better sit down now. Then the sensation in her throat was starting to feel like it was closing up, her lips were swollen; so she would say she was a little bit confused. The patient started getting dizzy and her thinking was not clear, her tongue swelled, she had a full tongue which effecting her talking, she was gasping for air, she needed a moment to regulate her breathing. In regards to swollen lips she added at first she had a tickle in the throat, tingling in her lips, restriction in her throat, then she started slurring her words before the ambulance got there. On site they responded and watched her because she did not know if the symptoms were going to get worse. The paramedics gave the caller oxygen and an IV, since she had a mild experience she wanted to see what she did not take any medications before taking the vaccine so she could see what it would do, she did not take an ibuprofen or Tylenol. Patient commented, she knew it was not recommended, but some people do it. The patient mentioned started speaking very badly and very fast, she started gulping for air, and was informed the histamines are hitting her. She felt like she was going to faint, she thought if she was able to count back from ten she was going to be knocked out. Once she counted back she started to feel better. Like she would not faint. She did not faint often. She mentioned counting backwards from ten when getting a colonoscopy or something like don't get passed five and then knocked out, so she knows the sensation that can occur. After 1.5 hours they decided to call the emergency number and that was when the ambulance came. The ambulance service was the one who did everything for the patient. Because the patient got in the ambulance, they required her to go to the hospital, she was in a bed in the hall, by the time her doctor had looked at her, her throat had opened up and was feeling reasonably well after an hour an half. Confirmed she was not admitted just in the Emergency Room. On 04Mar202 the patient was at the hospital and was gasping for breath. The patient was on an IV and they gave her 125 mg of Solu-Medrol, 50 mg of Benadryl, and 5 mg of nausea medicine, phedrol the caller thought it was called. They did a good job and that helped the patient down from the most severe symptoms and she wanted to report her symptoms. The patient has been looking around and she thought this reaction it was from the polyethylene glycol. She mentioned historically she had a minor reaction. She had to go hospital twice in last four months. One was for Amlodipine which has polyethylene glycol and another time for Lisinopril which is another blood pressure medication. She confirmed she visited the emergency room for all 3 of these cases. The patient was still very confused on 09Mar2021 and over the weekend, she had to rest, she was weak and fatigued. On 09Mar2021 it was first real day she went back to work. She worked and asked her brother to watch out for her. On 10Mar2021 she was starting to feel a little bit better as regarded anaphylactic reaction, she has recovered with residual effects from the anaphylactic reaction. Confusion was improved but stull a concern. The outcome of anaphylactic reaction was recovered with sequelae, of headache, swollen lips, confused was recovering, of gasping for air, dizzy, could not think clearly/her thinking was not clear, tongue swelling, throat closing/restriction in her throat, sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips was unknown. Patient asked if there was a conclusion about the PEG and her anaphylactic reaction. Her second dose was scheduled on 25Mar2021. Patient stated that her PCP and the CDC recommend to not get the second dose. Caller wanted to know if the anaphylaxis could be worse in the second dose. The patient wanted to know if she should she get the next dose. She was very concerned about COVID as well but did not know if it's worth her risking her life. Patient wanted to know if she can get the Johnson and Johnson vaccine after a certain amount of time after receiving the Pfizer COVID 19 vaccine, caller cannot get the second dose of the Pfizer COVID vaccine due to a reaction. As of 12Mar2021 patent stated she does not wish to be contacted any further. A Product Complaint was filed.
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| 65 | 2021-03-31 | feeling abnormal |
Progress Notes Date: 3/26/2021 ...
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Progress Notes Date: 3/26/2021 Subjective Patient is a 65 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching and head fog. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Had mild reaction to her fist COVID vaccine - has some head itching on right side Resolved without medications Initially with complaints of "feeling foggy" to frontal head Also feeling itching - more to right side of body. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin and dizziness (when up to bathroom) Patient denies fever, malaise/fatigue, sinus pressure, runny nose, cough, shortness of breath, wheezing, rash, vomiting, abdominal pain and diarrhea Previous Reactions: See above Objective Vitals Vitals: 03/26/21 1326 03/26/21 1346 03/26/21 1413 BP: (!) 156/83 (!) 161/80 (!) 152/75 Pulse: 59 68 SpO2: 99% 100% Physical Exam HENT: Head: Normocephalic. Cardiovascular: Rate and Rhythm: Normal rate. Pulses: Normal pulses. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No erythema or rash. Neurological: Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Benadryl given for itching - significant improvement in this noted Continues to complain of having "funny feeling" and fog. Denies headache and does not wish to have tylenol Blood pressure in the ED bay are slightly higher than her baseline Hx of migraine headaches, but this is not similar to that With medical history, pt does not feel comfortable with going home and would like to be evaluated in the ED They will go by private vehicle - husband here with her Report called to ED charge nurse. Electronically Signed by APRN 3/26/2021 2:38 PM Progress Notes Cosigned by: MD at 3/30/2021 8:03 AM Date: 3/26/2021 Subjective Pt is a 65 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching and head fog. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Had mild reaction to her fist COVID vaccine - has some head itching on right side Resolved without medications Initially with complaints of "feeling foggy" to frontal head Also feeling itching - more to right side of body. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin and dizziness (when up to bathroom) Patient denies fever, malaise/fatigue, sinus pressure, runny nose, cough, shortness of breath, wheezing, rash, vomiting, abdominal pain and diarrhea Previous Reactions: See above Objective Vitals Vitals: 03/26/21 1326 03/26/21 1346 03/26/21 1413 BP: (!) 156/83 (!) 161/80 (!) 152/75 Pulse: 59 68 SpO2: 99% 100% Physical Exam HENT: Head: Normocephalic. Cardiovascular: Rate and Rhythm: Normal rate. Pulses: Normal pulses. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No erythema or rash. Neurological: Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Benadryl given for itching - significant improvement in this noted Continues to complain of having "funny feeling" and fog. Denies headache and does not wish to have tylenol Blood pressure in the ED bay are slightly higher than her baseline Hx of migraine headaches, but this is not similar to that With medical history, pt does not feel comfortable with going home and would like to be evaluated in the ED They will go by private vehicle - husband here with her Report called to ED charge nurse. APRN Electronically Signed 3/26/2021 2:38 PM
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| 65 | 2021-03-31 | feeling abnormal |
About 8 minutes into the 15 min time, I felt a wave go across my stomach and about 2 min later, I fe...
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About 8 minutes into the 15 min time, I felt a wave go across my stomach and about 2 min later, I felt another wave go across my stomach. When my 15 min was up, I told the RN I didn't feel good. I told her I felt like I was going to pass out and I needed to use the bathroom. She pushed me forward and back. I pulled myself back to try and keep from passing out. The RN was taking my pulse, said it was Bradicardic. Then they got more people, I saw them running in and I remember hearing a CODE going over the speaker. I remember them saying check my blood sugar and keep the pulse ox on my finger if I didn't have oxgen on. When I came to, my vision was blurry and kinda in a fog. I remember saying I took a nap. When they put me on the stretcher, I had riggers and remember thinking, " put a coat on me!" After some tests, I was discharged.
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| 65 | 2021-03-31 | insomnia |
Shoulder, back, neck aches Feeling out of sorts Trouble sleeping slight runny nose (left nostril) Oc...
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Shoulder, back, neck aches Feeling out of sorts Trouble sleeping slight runny nose (left nostril) Occasionally pinch pain (left arm and shoulder) Cold sore (left nostril - same side of injection) Pain in right buttock
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| 65 | 2021-03-31 | loss of personal independence in daily activities, excessive sleepiness |
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni...
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Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
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| 65 | 2021-04-01 | agitation |
3/24/2021 11:20am Was administered my 2nd dose of COVID vaccine. 3/24/2021 10:00pm Lightheaded, diz...
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3/24/2021 11:20am Was administered my 2nd dose of COVID vaccine. 3/24/2021 10:00pm Lightheaded, dizzy, fever, chills, severe stomachache, severe lower backache, severe head and neck pain, severe nausea, vomiting, dry heaves, chest pain, rib pain, heartburn, rash on stomach and sides, sore throat, earache, eyes aching, physical distress and agitation X 72 hours. 3/28/2021 - 3/31/2021 All of the above symptoms continue but symptoms are moderate instead of severe. 4/1/2021 All of the above symptoms are minor.
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| 65 | 2021-04-01 | feeling abnormal, excessive sleepiness |
Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shou...
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Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers; didn't feel good; her fingers were frozen in a half closed position when she woke up in the morning; her body ached like she had arthritis; she couldn't eat and was barely hydrated; Hair loss; she couldn't eat and was barely hydrated; Tiredness/Fatigue extreme; Backache; "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning; sick; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: el9262, Expiration Date: Unknown) via intramuscular route of administration in left deltoid on 29Jan2021 (at the age of 65-year-old) at 13:15 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: Unknown) via an unspecified route of administration on 23Feb2021 as a single dose, both the doses for COVID-19 immunization. The patient medical history included Irritable bowel syndrome diagnosed 15 years ago (ongoing), ongoing Blood pressure high from an unknown date in 2000, high cholesterol for about 4-5 years or longer, depression (diagnosed in her 30s after a car accident), Type 2 diabetes mellitus (she couldn't take the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now), post-traumatic stress, she was bedridden for 2 weeks on an unknown date in feb2021 (only able to get up to go to the bathroom), it was hard for her to cook, wash clothes, and do anything on an unknown date in Feb2021. The patient underwent stress tests, and all was good right now. The patient did not receive any additional vaccines administered on same date of the Pfizer Suspect was none. The concomitant medication was not reported. The patient previously took historical vaccine, flu vaccine on an unknown date for immunisation and felt bad for 3-4 days. It was reported that after first dose patient has been so sick. The patient experienced back pain on 29Jan2021. She reports that starting the next day that was on 30Jan2021, she has experienced severe fatigue extreme and tiredness. She reports that her symptoms while a little better she is still tired all of the time. She reports "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning on an unknown date in Jan2021. Caller also reports, my joints are in severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers on an unknown date in Feb2021. My fingers are closed, and I can't straighten them out when I wake up". The patient put ice on her back and took pain pills and stuff. It was reported that patient had undergone back tests and result was not reported. The patient reported that she took she took Norco, or Hydrocodone/Acetaminophen 10mg/325mg. said her Norco 10mg/325mg prescription was for 1 Norco 10mg/325mg tablet every 6 hours, as needed, for pain. She said she normally would take 1 Norco 10mg/325mg tablet during the day, and another Norco 10mg/325mg tablet at bedtime. She said after her first COVID-19 Vaccine dose, she had been taking a Norco 10mg/325mg tablet every 6 hours. She said she also took a muscle relaxer, Tizanidine 4mg tablet. She said she took 1 Tizanidine 4mg tablet with the Norco 10mg/325mg tablet, three times a day. She said her backache felt like a belt across her lower back. She said when she has a backache, she gets off her feet, and puts her legs up on a pillow to take pressure off of her back. She said she rested, as well, but tried to do stuff around her house. She said she did have some tests on her back, and she had a fractured facet in her lower spine around the L1 vertebrae. She said she had to have some more tests done on her back. She said the backache she experienced after getting her COVID-19 Vaccine was not normal backache pain. It was Reported about 5-6 days after getting her first COVID-19 Vaccine, that was on an unknown date in Feb2021, her hair started falling out and the severity was explained by patient as "If I roll it up in a clump it's the size of a golf ball". She clarified she would brush her hair and would end up having hair everywhere (in her brush, on the counter, and floor). She said the day after she first noticed her hair falling out, she had even more hair fall out than normal. She said she was worried about her hair falling out and took Biotin and vitamins. She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. The patient took 1 vitamin Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support (UPC Number: 2791700026, Lot Number: WA01802798, Expiration Date: Dec2021). She stated she also took 2 Vitamin C 282mg Gummies (UPC Number: 2791702071, Lot Number: WAO1887038, Expiration Date: Jan2022) a day. She said the product label said to take 3 Vitamin C 282mg Gummies. She stated she also takes 2 Calcium (UPC Number: 2791701951, Lot Number: YY01548358, Expiration Date: Jun2022) 500mg per day. Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. Reported she was still tired. She clarified after she got her first COVID-19 Vaccine, she had felt tired for a few days with her back bothering her. She said she would get up and take her pain medicine, go to the bathroom, and get something to drink and go back to bed. She said she had felt a little better but wanted to take a nap every day. She said after she got her second COVID-19 Vaccine shot her tiredness was worse. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She clarified when she got home from her second COVID-19 Vaccine she was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad, she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she was exhausted from just going to a doctor's appointment. Reported every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were frozen in a half-closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to "unstick." Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and was to take 1 Prednisone 50mg tablet a day for 6 days. Reported she had severe nausea and vomiting on 25Feb2021 and clarified that the nausea and vomiting lasted 2 weeks. She said she took Phenergan and Zofran around the clock. She said she couldn't eat and was barely hydrated. Zofran 4mg tablet (NDC Number: 65862-187-30, Lot Number: OND420010-A, Expiration Date: Jun2024), as needed, three times a day. She said the Zofran was dispensed in a white manufacturer's bottle. Reported she needed to have some regular blood work done. The seriousness of the events Backache, Tiredness/Fatigue extreme, Hair loss, Feeling unwell, Joint pain, Nausea and Vomiting were reported as serious (medically significant) by the reporter. The final outcome of the events Backache, Tiredness/Fatigue extreme, Hair loss was not recovered; Feeling unwell, severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers, Nausea, Vomiting was recovering; didn't feel good, her fingers were frozen in a half-closed position when she woke up in the morning, her body ached like she had arthritis, she couldn't eat and was barely hydrated, sick and "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-04-01 | feeling abnormal |
Symptoms appeared Mar 18, 17 hours after administration, in a progression: 1) headache-dizzy-nausea...
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Symptoms appeared Mar 18, 17 hours after administration, in a progression: 1) headache-dizzy-nausea, 2) jittery-high b/p (160, normal for me is ~115)-faster pulse (76, normal for me is ~60), 3)sensation of flushing/rushing in head, neck, chest-brain fog-fainty, 4) wheezy @ base of throat & upper chest. Progression built over ~ 1 hour and subsided over ~1 hour. Symptoms started appearing again Mar 21 ~ 5:30p, but this time, I took an Allegra ~ 6:00p and went to Urgent Care. By the time I was seen ~ 6:30p the reaction was subsiding before reaching phase 3. All vitals were taken as well as an ECG and were normal except b/p was still high (167/80). Diagnosis was allergic reaction and I was advised to take a 2 week
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| 65 | 2021-04-02 | confusional state | Dizziness, Severe Loss of Balance, Headache and confusion. |
| 65 | 2021-04-04 | anxiety |
I had muscle spasms, cramping and aching cause lots of anxiety lasting a week intermittent not consi...
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I had muscle spasms, cramping and aching cause lots of anxiety lasting a week intermittent not consistent. I went to ER for muscle spasm and heart burn prescribed medication and follow up with my doctor.
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| 65 | 2021-04-04 | anxiety |
Extreme high pitched buzzing in my ears. Went to ENT my hearing is fine and my ear drums are normal....
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Extreme high pitched buzzing in my ears. Went to ENT my hearing is fine and my ear drums are normal. This is extremely annoying and causing me great anxiety.
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| 65 | 2021-04-04 | anxiety |
After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in lef...
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After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in left foot was painful and very high anxiety. I started exp cramping in my lower arms I have been to ER, PCP, Ophthalmologist and Neurologist. I'm having terrible headaches as well. The Opthamologist applied eye drops that cause me to go to ER on 4/2 had blood work, checked pressures in eyes, prescribed medications nausea/dizziness, pain in my head and IV for low sodium.
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| 65 | 2021-04-04 | sleep disorder, feeling abnormal | Instense ringing in ears , making sleep impossible and fog brain |
| 65 | 2021-04-05 | insomnia |
About 6:00pm on 4/1/21 (8hrs after 2nd vaccine) the bones in my torso began to hurt - hips, spine, s...
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About 6:00pm on 4/1/21 (8hrs after 2nd vaccine) the bones in my torso began to hurt - hips, spine, shoulders - at level 3 [on 10pt scale]. Pain increased rapidly from onset level 3 to level 6 in next 2 hrs until 8pm, and spread to leg bones, knee joints, neck. Bone pain kept increasing for 2-3hrs to level 7 and my arm bones, elbow joints, hand and foot bones, and skull finally hurt too, all at level 7-8 around 10pm and for the next 12-13hrs. Pain dropped to level 6-7 about 10:30am 4/2/21 and remained at that level for about 18hrs, or until 4:30am on 4/3/21, when it began to drop rapidly to level 0 by 10:am. I felt achy and exhausted from lack of sleep and had a level 4 headache until 4/4. Not muscle pain.
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| 65 | 2021-04-06 | anxiety | Racing heart, anxious. BPs 114/57 (pulse 69), 145/64 (pulse 67). |
| 65 | 2021-04-07 | insomnia |
Sharp neurological pains in right hip and going down right leg. Unable to sleep at night because of...
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Sharp neurological pains in right hip and going down right leg. Unable to sleep at night because of pain. Pain lasted past 3 weeks. Went to doctor to report it.
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| 65 | 2021-04-09 | insomnia, abnormal dreams |
weird dreams; slight dizziness; headache; nausea; fatigue; difficulty sleeping; This is a spontaneou...
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weird dreams; slight dizziness; headache; nausea; fatigue; difficulty sleeping; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613) at right arm, via an unspecified route of administration at left arm on 22Mar2021 14:30 (at the age of 65-year-old) at single dose for covid-19 immunization. Patient not pregnant at the time of vaccination. Medical history included depression, anxiety and hypothyroid. No known allergies reported. Concomitant medications included Synthroid and Estradiol. On 23Mar2021 12:00, day after starting the therapy, the patient experienced headache, nausea, fatigue, difficulty sleeping, on 25Mar2021 third day after the vaccination slight dizziness and weird dreams. The patient not received treatment for the adverse events. No covid tested post vaccination. The patient had no covid prior vaccination. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not been tested for COVID19, Since the vaccination. Seriousness as reported non-serious. The outcome of events was not recovered.
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| 65 | 2021-04-10 | excessive sleepiness |
Awoke at 2:30 with extreme chills, teeth chattering, fever, severe body aches and severe fatigue; it...
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Awoke at 2:30 with extreme chills, teeth chattering, fever, severe body aches and severe fatigue; it hurt to move. I had a severe headache that would not be relieved with 500mg. of Tylenol every 5 hours. The next day I also had nausea and fever and continued fatigue and pain, so that I slept for 24 hours with only fluids and fruit. Muscles were tense and achy for 18 hours. Also had heart racing and racing thoughts during the night. Extremely uncomfortable. I had no reaction with the first dose.
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| 65 | 2021-04-11 | panic attack | Caused panic attack Stomach upset and some diarrhea |
| 65 | 2021-04-12 | feeling abnormal, nervousness |
Patient stated that "I feel funny. I feel shaky and my fingers are all tingly." Pt's vitals were tak...
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Patient stated that "I feel funny. I feel shaky and my fingers are all tingly." Pt's vitals were taken and they were stable, pt was observed for 30 more minuets and was educated on the signs and symptoms of anaphylaxis and the symptoms happen. Upon discharge from the clinic, the pt stated that she was feeling better.
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| 65 | 2021-04-12 | insomnia |
Very painful between elbow and shoulder. Doesn't feel like a mussel more like shooting pains dependi...
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Very painful between elbow and shoulder. Doesn't feel like a mussel more like shooting pains depending on arm movement. Difficult sleeping.
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| 65 | 2021-04-12 | nervousness |
Sore arm - five days, fever and chills - one day, leg cramping - one day, cough and congestion - fou...
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Sore arm - five days, fever and chills - one day, leg cramping - one day, cough and congestion - four days, no appetite - two days, diarrhea - two days, dizzy and nauseous - four days, headache - nine days. Felt better - two weeks, Last three weeks - headache, feel jumpy, fast heart. Doctor prescribed Metoprolol.
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| 65 | 2021-04-13 | sensation of foreign body | Dizziness and felt that something was stuck in her throat causing difficulty swallowing. |
| 65 | 2021-04-15 | feeling abnormal |
After my 1st co-v inj, I began feeling extreme FATIGUE & BRAIN FOG 1 hour later. I was on a bicy...
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After my 1st co-v inj, I began feeling extreme FATIGUE & BRAIN FOG 1 hour later. I was on a bicycle for exercise as this was a 10.5-mile ride rt. Began hitting me on my ride home. For the remainder of the day and 2 days afterward, I stayed in bed. My 2nd inj is on the 28th. I am fine and back on the bike but thought I should report this.
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| 65 | 2021-04-15 | excessive sleepiness |
Patient received second Pfizer shot on Saturday, then on Sunday night, she had some heavy breathing....
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Patient received second Pfizer shot on Saturday, then on Sunday night, she had some heavy breathing. Her sinuses started acting up, too. She has no energy and wants to sleep all the time. Oxygen at home running 96-97 percent. Feels a heaviness in her chest which she thinks is due to asthma. She does not have a current inhaler. No wheezing and feels like she has to cough. She has some bloody nasal discharge when she blows her nose. Is using sinus rinses every morning and there is little mucus coming out. "
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| 65 | 2021-04-15 | mental status changes, abnormal behaviour |
My sister in law has vascular dementia. She had no side effects at all following her first Pfizer v...
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My sister in law has vascular dementia. She had no side effects at all following her first Pfizer vaccination. Following the 2nd dose, she reported feeling physically fine the next day, however, family and caregivers witnessed mental status changes including inappropriate laughing, hysteria and screaming during the night following her dose, and weird behaviors the following day. She is back to normal now but we wanted to report this in the event others with dementia have questions about side effects.
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| 65 | 2021-04-18 | mental status changes |
Altered mental status one hour after dose administered on 04/16/2021. Seen in ER for work-up. Stayed...
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Altered mental status one hour after dose administered on 04/16/2021. Seen in ER for work-up. Stayed in Clinical Decision Unit for observation and discharged 04/17/2021. Dx: Transient Global Amnesia
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| 65 | 2021-04-19 | insomnia |
By the end of the day on 3/31/21, I began experiencing severe/debilitating muscle spasms in my leg, ...
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By the end of the day on 3/31/21, I began experiencing severe/debilitating muscle spasms in my leg, feet, toes, and fingers. I have continued to get these cramps/spasms during the day and it is very scary when driving and your fingers curl up and you?re unable to drive. I am constantly awakened by these cramps if I am sleeping and have to get out of bed and try and work the spasms out. I was in my pool and i had severe spasms/cramping that scared me because i was in water. This is AWFUL and I NEVER had these muscle spasms like I have been experiencing. I?m afraid that these debilitating musical spasms may lead to crippling or unable to drive/walk especially if I take the second vaccine shot.
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| 65 | 2021-04-20 | anxiety |
1ST DOSE PFIZER VACCINE ADMINISTERED AT 6AM, EMS CALLED AT 12P DUE TO DIZZINESS AND CHILLS. PATIENT ...
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1ST DOSE PFIZER VACCINE ADMINISTERED AT 6AM, EMS CALLED AT 12P DUE TO DIZZINESS AND CHILLS. PATIENT SEEMED ANXIOUS PRIOR TO VACCINE ADMINISTRATION
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| 65 | 2021-04-20 | confusional state |
brought in to Nurse treatment Center for sudden onset of confusion. Per patient she could not remem...
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brought in to Nurse treatment Center for sudden onset of confusion. Per patient she could not remember recent events that transpired early on today. She states she is at a facility. She recognizes husband at the bedside. She denies dizziness or lightheadedness. She is not oriented with time and date. Patient got her second covid vaccine at 11:45 this morning and went to lunch with husband after. Per husband noticed the sudden onset of confusion at around 12:15 during lunch. Patient was then brought in the clinic.
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| 65 | 2021-04-20 | sensation of foreign body |
Typical soreness at injection point, went away 1 day; left arm especially hit with arthritis pain, l...
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Typical soreness at injection point, went away 1 day; left arm especially hit with arthritis pain, lasted 2 days but also pain up into neck area to present date (4-21-21). Sore jaw approx. 5 days later along with body aches. Sore throat - felt like lumps both sides of esophagus. Severe dizzy spells ... first started on 04-11-21, was coughing and became extremely light headed, blackness, and eyes felt as if in some sort of seizure - as if vibrating at accelerated speed - nearly passed out. Have experienced similar dizzy spells, less the seizure like symptom, since that time, generally brought on during coughing (which I have the 9/11 Rescue Workers 'WTC' cough).
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| 65 | 2021-04-23 | loss of personal independence in daily activities |
Twelve hours after vaccine I felt like I was freezing and hot at the same time. I had muscle cramps ...
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Twelve hours after vaccine I felt like I was freezing and hot at the same time. I had muscle cramps and complete body fatigue and felt like I had the flu. I couldn't get up and do my usual thing, I'm really afraid to take the next shot if it's going to be worse than the first one.
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| 65 | 2021-04-24 | hallucination |
Fever. Chills, hallucinations, renal failure, ischemic colitis, gi bleed, blood clot,, dehydrat...
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Fever. Chills, hallucinations, renal failure, ischemic colitis, gi bleed, blood clot,, dehydration
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| 65 | 2021-04-24 | sleep disorder |
First the injection site bleed a lot, then a subcutaneous hematoma about 1 1/2 inches in diameter d...
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First the injection site bleed a lot, then a subcutaneous hematoma about 1 1/2 inches in diameter developed. As night came on my arm ached more than the first injection event and then my whole body started to ache. It was a night of little sleep due to the aches all over the body. The next day it was like I had a very bad flu, there was a bad headache, body aches, heart hurt and I kept having to empty the bowels and couldn't eat or drink much. Later in the day I threw up everything. Was feeling a little better by 2 days later, but even now am not up to previous energy levels.
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| 65 | 2021-04-26 | anxiety, agitation |
emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wh...
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emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wheezing cough; she had a sore throat; agitation; chills; anxiety; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tightness in her chest; felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7534), via an unspecified route of administration, administered in Left Arm on 23Mar2021 19:00 as single dose for COVID-19 immunisation. Medical history included ongoing laryngopharyngeal reflux diagnosed about 5 years ago, ongoing anxiety, usually happens during stressful circumstances; diagnosed about 20 years ago and she had had the sensation of labored breathing, dry mouth, and accelerated heart rate then yes for work like with public speaking; sensitive: Sulfa drugs, aesthetic filler in her face and allergic reaction Hyaluronic acid filler collagen and she doesn't smoke and drink. Family history included daughter was diagnosed with psychotic episode and diagnosed with mental illness and it was stressful getting that under control and she was sensitive to medication and surgical procedures she doesn't tolerate narcotics. Concomitant medication included clonazepam (KLONOPIN). She reported that she was prescribed .125 of clonazepam and it was a dissolvable sublingual and she doesn't use it frequently as she has read about reliance and potentially addictive and she will take a walk or watch a boring video to try to get her mind off it. The patient previously took oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and she was sensitive to Percocet; and darvocet and experienced sensitive to Darvocet post surgery; and codeine, and vicodin and was sensitive to both drugs, advil and causes her stomach to be upset, shingles vaccine, HPV vaccine, chicken pox vaccine and got 1 pox from that about 15 years ago when it first came out. The only post-surgical medicine pain reliever she can take was Tramadol and more often than not she doesn't have to do anything beyond Tylenol extra strength. On 24Mar2021, 04:00, the patient experienced extreme chills, and anxiety accompanied with tight, shallow, and labored breathing. She had troubled breathing due to this. She mentioned that she went to the emergency room (ER) that morning. On 27Mar2021, the patient had emphysema and agitation. On 26Mar2021, early in the morning, she had the breathing issue that she mentioned first concurrent with agitation and anxiety like at same time with the extreme chills. The sensation of agitation was all combined together, it like hit out of the blue while she was getting ready to go to sleep. She stated that at 4am it hit her with a sudden bout of extreme chills and at the same time a sense of anxiety, it felt like she hit a wall and couldn't get a full breath. She stays up late but wasn't doing anything anxiety provoking, she thought she was reading recipes. She sat to calm herself as she was not sure if it was a reaction or anxiety at the initial reaction fueling it further so she tried to sort of lower everything in her system and was concerned it could accelerate and not subside. At the hospital, they took her in an exam room and did her vitals and she was there about 2-3 hours and it was early in the morning and at that point sometime they took a chest x-ray, EKG, and blood work and at that point prior to that while she was waiting she was feeling a little better, the worst had subsided and she suggested she go and they asked her to stay since she was already checked in and to be seen. The doctor looked at the results and read the film and questioned about emphysema and she felt that was unrealistic reading as she doesn't smoke, doesn't drink and it's not in her genetic make up. The doctor told her lungs were showing a lot of air and she said maybe it was because she was gasping and they told her to take a big gulp of a breath and hold it to get the X-ray. The doctor suggested she see a pulmonologist and she didn't feel that was warranted. She contacted her general practitioner and they recommended she get the 2nd shot and had her see an allergist who also suggested she get the 2nd shot. The patient stated that she was not really overweight and doesn't drink and doesn't smoke and the allergist didn't mention but she saw in the paperwork that a side effect could be difficulty breathing. She had no swelling, body rash, dizziness or weakness. Since that episode, she periodically throughout the day, and she can't tell if it's anxiety or allergies or something but she felt labored breathing and tightness in her chest and can't get a full intake of breath. She reported that when she sleeps on her back the sensation disappears completely and when she sleeps on her side it reappears a little; 1-2 nights after, it woke her from sleep and she doesn't think she was dreaming about anxiety. She stated that she has never had anaphylactic if this should escalate what to do and she decided to go to the ER and they had her wait an additional 2 hours for a follow-up reading that was all clear, all fine, except emphysema thing which was again, she was just researching and forgot the medical term, she this it was hype aeration, too much air sucked in. Her general practitioner recommended she see an allergist for a 2nd opinion and was surprised she was up on anything and didn't mention side effect and the handout said it could be a possible side effect. She has to yawn a lotto get the air in. She does have laryngopharyngeal reflux prior and she clears her throat which is probably annoying and controls that through diet instead of taking Pepcid AC. She has had to clear her throat a lot but never had labored breathing or shortness of breath, that to get a full breath sometimes she has to yawn to get past that tightness of shallow breathing or labored breathing. On certain days she doesn't feel it and thinks it was done and she will have a spate and it happens and she thought there was something stressing and does a reality check and again it's that time of year and when she was taking her walk and walked past a certain block she started to wheeze from the pollen on an unspecified date and she called her allergist to see about getting something. She had a mask and that helped a little. Her allergies were not exacerbating on 23Mar2021 or 26Mar2021 but started the last few days and she has a wheezing cough that had an extended sort of wheeze at the end of the cough. Before her cough for LPR it was annoying throat clearing. After the vaccine, she took that walk through that one specific spot on her route she got to coughing and thinking she needs to call and get something prescribed something if anything if she gets the second shot it will address any of the side issues if they were related to allergies so don't have to contend. It was every night where she sort of feels it and she sleeps through the night so if it was tension related it subsides and can't distinguish what is emotional and physical but she was sleeping through the night and it was an indication that it was improving. She reported that when she visited her son and after she returned he told her he was unaware he had strep and didn't know it, he was asymptomatic and she had a sore throat and went to urgent care and had an exam and didn't have strep and doesn't know what it was but she was feeling better by the weekend. She was supposed to go back and everything was shutting and she didn't go. Maybe she was exposed and just had a mild thing while she was there. She was tested for Covid on 26Mar2021 and her result was negative, but they did not do an antibody test. She wanted to know if difficulty breathing was a common reaction with the vaccine, and if the side effects would be lesser after the 2nd dose since she already had a severe reaction after the 1st dose and if she should still receive the 2nd dose of the vaccine. She was concerned the 2nd shot will be more pronounced than the 1st and she doesn't want to go through that and it be more severe. She has heard if you had that reaction you may have been exposed to Covid before and she may have been around people with Covid that had positives and she may have antibodies from an asymptomatic experience and it may do more harm than good and she should do the 2nd shot. She mentioned this to her allergist and was told if she has a similar symptoms to call and get a bronchodilator. She was onboard with that but wants to discuss it because she finds it hard to believe she was the only one that had difficulty breathing and was wondering what was the duration of this labored breathing. She was scheduled for the second dose 18Apr2021. Outcome of events sore throat was recovered on an unspecified date; and outcome of rest of events was unknown.
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| 65 | 2021-04-26 | feeling abnormal, memory impairment |
Two days after the vaccine, I started feeling great lethargy. I slept all day 4/17 & 4/18. I got up...
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Two days after the vaccine, I started feeling great lethargy. I slept all day 4/17 & 4/18. I got up, had coffee and went right back to bed and slept all day, got up, ate dinner and slept all night for both days. Starting on 4/19, I started getting sharp headaches at about 10 am. As time goes on, the headaches are starting later in the day. Yesterday, 4/26, it didn't start until about 4 pm. Today (4/27), however, it started about 11:30 am. I was concerned about being dehydrated, so I have been drinking Pedialyte. It doesn't really help. I am also still tired, but don't have to nap - I can work all day and just go to bed early (7:30/8 pm). The headaches are so severe that I also feel sick to my stomach. I am also very fuzzy headed - I have trouble remembering things. This started with the headaches and happens even if the sharp pain is not present. By 4/22, the fuzzy head feeling was nearly gone. While it was happening, I didn't feel safe to be driving, and did not drive. Even though the fuzzy head feeling is leaving, I am still forgetting words and have a slight, occasional stutter when talking. I also forget things I am supposed to be doing. The headaches persist.
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| 65 | 2021-04-27 | anxiety |
was weak and could barely get out of bed; lots of muscle pain in back and legs; sweating and was hot...
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was weak and could barely get out of bed; lots of muscle pain in back and legs; sweating and was hot but no temperature; mild headache; anxiety; strange short term body aches; left arm and left side of body began to hurt; so fatigued; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm on 21Feb2021 at 11:45, (at the age of 65-year-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient medical history included breast cancer from 2005, Diabetes II, had Cervical spine surgery-C5,6 & C 7- surgery (went very well), compromised immune system, allergies, sinus issues, known allergies to sulfa and IVP Dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received concomitant medication which was not specified. The patient previously took Iodine and Levaquin and experienced allergy. On 21Feb2021, at 15:00, 3 hours after shot became so fatigued that she could not continue to drive car, a few hours after that left arm and left side of body began to hurt, next day was weak and could barely get out of bed- lots of muscle pain in back and legs, sweating and was hot but no temperature- mild headache, anxiety & strange short term body aches. The patient did not receive treatment to the events. The outcome of the events was recovering.
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| 65 | 2021-04-29 | agitation | Slight chills, stomach upset, excitability, sore arm, blurry vision.......these did not last long. |
| 65 | 2021-04-29 | feeling abnormal |
1st inj left me fatiqued with brain fog for 3 days. 2nd inj left me with a fever of 101 degrees and...
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1st inj left me fatiqued with brain fog for 3 days. 2nd inj left me with a fever of 101 degrees and aches the next day and night. Very tired today but fever is very low to almost none.
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| 65 | 2021-04-30 | insomnia |
coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she tho...
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coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she thought she cracked her rib/ rib pain; acute pain on the left side, she thought she cracked her rib/ rib pain; didn't sleep at all; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8757) at the age of 65-year-old, via an unspecified route of administration on left arm on 31Mar2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. There were no additional vaccines administered on the same date and no vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took aspirin and experienced allergy which was described as deadly. She never took medications since she found that out at 16-year-old. The patient received her first shot on 31Mar2021 at a pharmacy and mentioned that she was not sick at the time of vaccination, but she had a violent reaction to it. When she received it, she didn't feel anything. People said you will get a sore arm, but she got none of that. Then in the middle of the night on Friday (02Apr2021) probably around 3:00, she woke up with acute pain on the left side, it was rib pain, she thought she cracked her rib. On the same day, she also experienced difficulty breathing, and didn't sleep at all. On Saturday morning (03Apr2021), when she woke up, she had nausea, a headache, and extreme fatigue, but wondered if the extreme fatigue was because she did not sleep. The nausea and headache went away 8 hours later, on the same day. On Sunday (04Apr2021), she was coughing and coughed up blood. When she coughed, there was blood in the mucous. She mentioned that she still has acute pain, she could not get comfortable. Her sister passed away in January and she had a 5 pm train she was supposed to catch, she was responsible for the funeral. She was thinking that if she went to a hospital, they would keep her for 24 hours, she could maybe make it to the funeral but that was questionable. By Monday (05Apr2021), the acute pain was gone, she still had a cough, there was still blood in the mucous, she has occasionally blood in the mucous. The cough has not gone away but she was getting better every day. The difficulty breathing continued until about 08Apr2021 (as reported), but she still has some shortness of breath, but nowhere near as bad. She consulted her notes and said she was at 30% on 03Apr2021 and she felt today that she was at 80% and every day she was a little better and better. She has to sleep upright, she was afraid to sleep flat, she slept in her chair, last night for 2 nights she slept upright in her bed. She probably could lay down, but she was more comfortable upright. Because she was sleeping upright, she was not fatigued, she was not sleeping well but she didn't think that has anything to do with what was going on. The events did not result in emergency room or physician office visit. She is supposed to get her second dose on 21Apr2021but she did not want to get the second shot. She asked if she could wait and get the one shot from Johnson & Johnson. She didn't know where to go anymore. The outcome of the event "acute pain on the left side, she thought she cracked her rib/ rib pain" was recovered on 05Apr2021, recovered on 03Apr2021 for "nausea" and "headache", recovered on Apr2021 for "extreme fatigue", not recovered for "didn't sleep at all", and recovering for all other events.
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| 65 | 2021-05-03 | insomnia |
cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness a...
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cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness aches all over body, pain not quellable with Tylenol headache sensitive glands all lasting about 12 hours this was my 2nd dose, first dose had no effects except for site soreness
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| 65 | 2021-05-07 | fear |
I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I h...
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I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I had like a headache on my left side.; inside of my mouth just started moving; It scared me; had side of my face was sore; I had my head hurt and I am like, my neck, oh my god, what's going on; I had my head hurt and I am like, my neck, oh my god, what's going on; it's wiggling like it and while I am breathing there is a time I go like (consumer imitates like breath-ing is stopped) and then breathing normally; This is a spontaneous report from contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 02Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history included high blood pressure and Sinus. The patient's concomitant medications included metoprolol (blood pressure), amlodipine (blood pressure), diazepam and gabapentin (problem with my leg). The patient reported on an unknown date, that she was having a reaction and got her second shot over three weeks ago. The patient experience last night was not just having bad, my mouth was moving out of control, it was like wiggling and stopping wiggling and stopping, it did all the night and up my mouth on my left side is moving, it's wiggling like it and while I am breathing there is a time I go like (consumer imitates like breathing is stopped) and then breathing normally, face just moved on it's own, it did a few time but last night which it, did it to the moment it kept doing it, kept doing it and then had like a headache on my left side. Patient was trying to sleep, for today this morning, inside of my mouth just started moving, You know, fast, fast and air coming out and this woke me up and now things started again and air coming out, oh my god, It scared me and noticed that when I am sitting up or laying it coming up and then it go back to normal. Patient had side of her face was sore and they did it so fast and quick, could hear doing stop and had my head hurt and I am like, my neck, oh my god, what's going on. Patient at the hospital had Ultrasound and X ray done. Patient took Tylenol. The outcome of the events was reported as unknown. Follow up#1 (PRD 25Apr2021, SRD 26Apr2021): This is a follow up spontaneous report from a 65-year-old female contactable consumer. This consumer (patient) reported information included concomitant medication, medical history, events, outcome, lab data. Follow up attempts are needed. Further information has been requested.
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| 65 | 2021-05-09 | loss of personal independence in daily activities |
My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh...
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My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh, left knee and left calf whenever I sat, walked, went up and down stairs, while sleeping and I was limited in what activities I was able to do without pain. I went to the doctor on 3/29/2021 (9 days after my first shot) and the doctor sent me for an ultrasound of the left leg and an X-ray of the left ankle..
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| 65 | 2021-05-10 | insomnia |
Whole Leg Pain after second dose of Covid Vaccine; Lower back sore intermittently; This also occurre...
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Whole Leg Pain after second dose of Covid Vaccine; Lower back sore intermittently; This also occurred after both vaccines.; Leg pain making it hard to sleep; This is a spontaneous report from PPDi. A contactable nurse reported herself that a 65-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Deltoid Right on 20Apr2021 10:15 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, with Age at Time of Vaccination at 65 years old. Medical history included ongoing blood cholesterol increased (Verbatim: High cholesterol. Stated she was diagnosed about 30 years ago. Said it was hereditary), ongoing autoimmune thyroiditis (Verbatim: Hashimoto's thyroiditis. Stated she was diagnosed about 20 years ago). Historical vaccine included first dose of Covid Vaccine (Batch/lot number: ER8727) on 29Mar2021 given at 1030, at Left Deltoid and experienced whole leg pain (about 2 weeks after the first vaccine she started having leg pain). Concomitant medications included rosuvastatin taken for blood cholesterol from an unspecified start date to Apr2021 (reported as Started medication about 3 years ago. Stopped a few weeks after the first dose of the vaccine, was not on any cholesterol medication at this time); levothyroxine sodium (UNITHROID) taken for autoimmune thyroiditis from an unspecified start date and ongoing. The patient experienced whole leg pain after second dose of covid vaccine (medically significant) on Apr2021 with outcome of not recovered, lower back sore intermittently (non-serious) on Apr2021 with outcome of not recovered, leg pain making it hard to sleep (non-serious) on Apr2021 with outcome of unknown. The patient underwent lab tests which included ultrasound doppler: no blood clots on Apr2021. Reported she went for her second vaccine and about 5 days later the leg pain came back. Said she took Tylenol and Motrin, nothing helps the pain. Said her legs have been hurting for about 4 days now. Stated that her pain seems unusual because it goes all the way down into her ankles and travels back and forth. Caller stated that she was a hiker and was in amazing shape. She had not done anything different, nothing that would have exacerbated this. Caller states she retired after being a Licensed Practical Nurse for 30 years in 2019. Caller stated that the leg pain after her first vaccine started about 2 weeks after the vaccine and lasted for about a week. Said it ended a few days before she got the second vaccine. Caller stated that her leg pain after the second vaccine was ongoing. Said that she got the vaccine on a Tuesday and her legs started to hurt again around Friday. Said that was effecting her life. Her legs hurt in every position. It was making it hard for her to sleep. Stated she believed her symptoms were medically significant as she did not know for sure what was causing them. Later in the call the caller mentioned that she had issues with her back. Said she noticed something new. Her lower back was sometimes sore. It comes and goes intermittently; unlike the leg pain that was constant. Stated the back pain fluctuates from a pressure and mild ache to soreness. This also occurred after both vaccines. Treatment received included: Tylenol and Motrin that did not offer any relief for her leg pains: Tylenol Extra Strength 500mg; P121876; Expiration Date: Sep 2023. Stated she took 2 tablets at a time. Motrin 200mg; 0GE2545A; Expiration Date: Mar 2022. Stated she took 2 tablets at a time. Causality: Stated she was uncertain if her symptoms have been caused by the Covid Vaccine. Follow-up attempts have been completed.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination BNT162B2 played a contributory role in triggering the onset of the event pain in extremity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.,Linked Report(s) : 2021467913 same patient/drug, different vaccine dose/AE
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| 65 | 2021-05-13 | hallucination |
Hallucinations; This is a spontaneous report from a contactable consumer, reporting for herself. A 6...
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Hallucinations; This is a spontaneous report from a contactable consumer, reporting for herself. A 65-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (Lot Number: ER8729) at 65 years of age on 06Apr2021 at 9:30AM for covid-19 immunization and experienced slurred speech and confusion for a week starting 07Apr2021 12:00AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, the patient experienced hallucinations. Prior to and since the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of the event was unknown. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
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| 65 | 2021-05-19 | loss of personal independence in daily activities |
Sore throat, Fever, unspecified fever cause, Exposure to COVID-19 virus ED to Hosp-Admission Discha...
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Sore throat, Fever, unspecified fever cause, Exposure to COVID-19 virus ED to Hosp-Admission Discharged 4/1/2021 - 5/14/2021 (43 days) Hospital MD Last attending o Treatment team COVID-19 Principal problem Discharge Summary MD (Physician) o o Internal Medicine HOSPITAL DISCHARGE SUMMARY HOSPITALIST GROUP . Patient: Date: 5/14/2021 DOB: Admission Date: 4/1/2021 MRN: Length of stay: 43 Days PCP:MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems Hospital Course HPI: Past medical history significant for type 1 diabetes mellitus, essential hypertension, obstructive sleep apnea, peripheral vascular disease status post femoropopliteal bypass 2016, status post multiple toe amputations on left foot, history of right foot osteomyelitis, left foot osteomyelitis in November 2020 who presented to ER on 4/1/2021 with shortness of breath. She was diagnosed with acute hypoxic respiratory insufficiency in the setting of Covid pneumonia with AKI, hyponatremia, troponin elevation, LFT elevation admitted to regular floor on high flow nasal cannula oxygen. Patient was intubated on 4/2/2021 for increased work of breathing and worsening hypoxemia and hypercapnia. Later patient was found to have persistent Candida fungemia. Hospital Course: Persistant Candida fungemia, now improving Blood cultures positive for Candida albicans from 4/12, 4/14 and 4/17/2021. Cardiology was consulted for TEE, done on 04/30 which was negative for vegetations. Ophthalmology was consulted and there was no evidence of fungal endophthalmitis. Blood cultures from 4/23/2021 so far no growth. PICC line has been placed. ID recommendations appreciated. -Currently patient on 6 weeks of IV micafungin, to be continued through 6/7/2021 as per ID recommendations. ID has therapy plan in system Moderate to severe pharyngeal dysphagia Post extubation SLP and modified barium swallow demonstrated aspiration with thin and thickened liquids. S/p PEG tube on 5/7/2021. CT head did not reveal any infarct. Repeat modified barium swallow done today , patient now advanced to level 3 soft diet with thin liquids. -Continue with tube feeds and alter tube feeds based on patient's diet advancement Type I Diabetes mellitus: Labile blood sugars in the setting of changes done to tube feeding. Patient currently on tube feeding and diet has been advanced today. Regimen at the time of discharge Lantus twice daily: With sliding scale insulin and standing dose of short-acting insulin with tube feeds bolus. -Patient will need close monitoring of her blood sugars given changes being done to tube feed and diet advancement, will need titration of insulin based on blood sugars. Lower extremity edema, improved Likely dependent lower extremity edema. Echo April 2021 reviewed: Normal EF, no diastolic dysfunction. -Elevate legs while patient is seated -Ace wraps -Restarted home dose of hydrochlorothiazide Acute on chronic anemia Received 1 unit of blood transfusion during this hospitalization Monitor hemoglobin Vitamin B12 and folate level normal. Hb on last check was 8.0 COVID-19 pneumonia Acute hypoxic and hypercapnic respiratory failure -resolved Status post extubation 04/06/2021 Treated with Remdesivir,convalescent plasma, Decadron as well as Tocilizumab. Treated with IV vancomycin, Levaquin and cefepime in the setting of possible secondary bacterial pneumonia. CT chest ruled out PE but showed extensive infiltrates on admission. Patient is off Covid precautions Currently saturating well on room air and stable from respiratory standpoint. Elevated d dimer, POA : Patient had elevated D-dimer on presentation. Lower extremity ultrasound 4/3/2021 was negative for DVT. CT chest ruled out PE. She was initially placed on intermediate dose of anticoagulation. D-dimer eventually trended down. Currently patient is on subcu heparin for prophylaxis. AKI POA now resolved Creatinine stable. -Continue to monitor renal function, electrolytes and urine output. Hypernatremia : resolved Acute Urinary retention, now resolved. Foley catheter was placed on 4/24 after patient had multiple straight cath done. DC'd Foley catheter on 5/3/2021. Patient is currently voiding without any issues. Chronic medical issues : o Essential Hypertension: On amlodipine, Coreg and hydrochlorothiazide. o Peripheral vascular disease status post femoropopliteal bypass: Restarted home aspirin, statin. _ Admission Current 5/14/2021 - present (6 days) Hospital MD Last attending o Treatment team COVID-19 with multiple comorbidities Principal problem Physical Medicine and Rehabilitation History and Physical Date: 5/14/2021 Admission Date: (Not on file) PCP: MD DOB: Hospitalist: MD Assessments Patient is a 65 y.o. female on hospital day number 0 Active Problems: No Active Hospital Problems: There are no active hospital problems currently on the Problem List. Please update the Hospital Problem List and refresh. IMPRESSION / PLAN: 1. Covid pneumonia/sepsis with hypoxic respiratory failure Received remdesivir, dexamethasone, convalescent plasma Received IL-6 inhibitor Intubation 4/1/2021–extubated, O2 weaned and now tolerating room air CTA chest 4/22/2021–extensive consolidation in both lungs C/W Covid pneumonia, no PE 2. Diabetes mellitus type 1 Lantus scheduled dose twice daily Humalog every 6 hours scheduled and sliding scale Insulin to be adjusted as PEG feedings decrease 3. Diabetic peripheral neuropathy arterial insufficiency Status post femoropopliteal bypass 2016– Status post right common femoral and mid popliteal bypass 9/28/2020 Dr. –no use of synthetic graft Status post remote history of multiple toe amputations left foot osteomyelitis Acute necrotic areas of feet being treated locally 4. Candida albicans fungemia On 6-week course of IV micafungin Weekly CBC, LFT, sed rate, CRP and BMP 5. Essential hypertension On amlodipine, carvedilol, HCTZ, 6. Dysphagia PEG tube placed 5/7/2021–Dr. Cleared for dysphagia level 3 soft diet thin liquids 5/14/2021 Aspiration precautions Speech and Language Pathology 7. Decreased ambulation and functional mobility and functional ability for activities of daily living Physical therapy, Occupational Therapy Plan Patient is admitted for comprehensive inpatient rehabilitation program consisting of physical therapy, Occupational Therapy, speech and language pathology, rehabilitative nursing, psychology, and case management support. Goals will be aligned with patient family goals and directed to improving functional mobility, functional interaction, and activities of daily living to allow the patient to return home safely and continue his rehabilitation as an outpatient or at a home health basis. Estimated length of stay is 16 days. Patient has a good prognosis History of Present Illness Patient is an 65 y.o. female with history of diabetes mellitus type 1 hypertension and sleep apnea who became febrile with shortness of breath over several days. Her PCP, Dr, ordered Covid test which was positive. She presented to Hospital on 4/1/2021 for further work-up. On admission she was found to be in hypoxic respiratory failure requiring high flow oxygen which progressed to requiring a nonrebreather and eventually intubation with ICU care. She received remdesivir, dexamethasone, and convalescent plasma. Patient also received IL-6 inhibitor Tocilizumab recommendation of pulmonary critical care. Procalcitonin level was 35.32. Because of concern of superimposed bacterial pneumonia she was also treated with broad-spectrum antibiotics. Patient had a prolonged complicated acute care hospital course. On 4/12/2021 ENT evaluation showed poor phonatory effort but mobile true vocal cord without lesions. Patient was found to have a fungemia from cultures of 4/12/2021 of C albicans with positive blood cultures with C. albicans on 4/17/2021. Patient was placed on IV micafungin for a total of 6-week course. TEE showed no evidence of acute valve pathology. Ophthalmology was consulted and there was no evidence of fungal endophthalmitis. Repeat blood cultures from 4/23/2021 showed no growth. Patient had PEG tube placed by Dr of GI on 5/7/2021. Repeat modified barium swallow on 5/14/2021 showed improvement of swallowing and the patient was upgraded to a dysphagia level 3 soft diet with double swallows and thin liquids via cup or straw with aspiration precautions. Patient was evaluated by therapies while at Hospital acute care. She requires supervision to rise from sit to stand using a rolling walker and contact-guard ambulate 45 feet using a rolling walker with wheelchair follow and verbal cues for walker management. She continues to have some knee buckling. She needs minimal assistance for bathing and min mod assistance for lower body dressing. She is able to perform toileting with contact-guard. Acute inpatient rehabilitation was recommended. Patient is being transferred to the Hospital for comprehensive inpatient rehabilitation program. Additional information for Item 19: Updated Procedure 04/01/21 1217 Respiratory virus detection panel Collected: 04/01/21 0917 | Final result | Specimen: Swab from Nasopharynx Adenovirus Not Detected Mycoplasma pneumoniae Not Detected Chlamydophila pneumoniae Not Detected Parainfluenza Not Detected COVID-19 SARS-CoV-2 Overall Result DetectedCritical Enterovirus/Rhinovirus Not Detected Coronavirus Not Detected Respiratory Synctial Virus Not Detected Influenza A Not Detected Bordetella pertussis Not Detected Influenza B Not Detected Bordetella parapertussis Not Detected Metapneumovirus Not Detected 03/27/21 1807 COVID-19 (SARS CoV-2,RNA Molecular Amplification) Collected: 03/27/21 0859 | Final result | Specimen: Swab COVID-19 SARS-CoV-2 Overall Result DetectedCritical Labs/Imaging LABORATORY: CBC: Results from last 7 days Lab Units 05/13/21 0557 05/10/21 0614 05/09/21 0724 WBC AUTO K/mcL 5.4 5.0 4.7 HEMOGLOBIN g/dL 8.0* 8.0* 8.5* HEMATOCRIT % 24.7* 25.3* 26.4* PLATELETS K/mcL 201 197 196 NEUTROS PCT AUTO % 67 -- -- LYMPHS PCT AUTO % 21 -- -- MONOS PCT AUTO % 8 -- -- EOS PCT AUTO % 4 -- -- CHEMISTRY: Results from last 7 days Lab Units 05/14/21 0609 05/13/21 0557 05/10/21 0614 SODIUM mmol/L 137 134* 136 POTASSIUM mmol/L 4.2 4.2 3.9 CHLORIDE mmol/L 103 101 104 CO2 mmol/L 28 25 26 BUN mg/dL 23 21 16 CREATININE mg/dL 0.86 0.78 0.82 CALCIUM mg/dL 9.0 8.8 8.6 Results from last 7 days Lab Units 05/14/21 0609 05/13/21 0557 05/10/21 0614 MAGNESIUM mg/dL 2.0 1.9 1.7 COAGULATION: OTHER TESTS: 0 Lab Value Date/Time TROPONINI 0.10 (H) 04/06/2021 0412 TROPONINI 0.17 (H) 04/03/2021 0436 TROPONINI 0.29 (H) 04/02/2021 1655 TROPONINI 0.28 (H) 04/02/2021 1323 TROPONINI 0.29 (H) 04/02/2021 1107 TROPONINI 0.28 (H) 04/02/2021 0546 TROPONINI 0.38 (H) 04/01/2021 1248 TROPONINI 0.15 (H) 04/01/2021 0857 TROPONINI 0.01 11/27/2012 0522 TROPONINI 0.08 (H) 11/26/2012 1104 TROPONINI 0.04 11/26/2012 0626 TROPONINI 0.04 11/25/2012 2304 IMAGING: Gastrostomy tube, place Result Date: 5/7/2021 Gastrostomy tube, place Procedure Note Surgical Pre-Operative Patient Identification Yes, after the patient was placed on the operating room/procedure table, I confirmed the patient's identity. Impression Overall Impression: Normal EGD up to second part of duodenum. 20 French PEG placed without any immediate complications. Recommendation There is no recommended follow-up for this procedure. Okay to use back for medications and water flushes. Start feeding via PEG tomorrow after GI evaluation. Indication Pre-procedure diagnosis: Pharyngeal dysphagia Post-procedure diagnosis: See impression Preprocedure A history and physical has been performed, and patient medication allergies have been reviewed. The patient's tolerance of previous anesthesia has been reviewed. The risks and benefits of the procedure and the sedation options and risks were discussed with the patient. All questions were answered and informed consent obtained. Details of the Procedure The patient underwent monitored anesthesia care, which was administered by an anesthesia professional. The patient's blood pressure, heart rate, level of consciousness, oxygen, respirations, ETCO2 and ECG were monitored throughout the procedure. The scope was introduced through the mouth and advanced to the second part of the duodenum. Retroflexion was performed in the cardia, fundus and incisura. The patient experienced no blood loss. The procedure was not difficult. The patient tolerated the procedure well. There were no apparent complications. See anesthesia record for more information regarding anesthesia administered. Specimens * No specimens in log * Implants No implants documented in log. I attest the accuracy of any implant/graft nursing documentation. Findings The cricopharynx, upper third of the esophagus, middle third of the esophagus, lower third of the esophagus, GE junction, Z-line, cardia, fundus of the stomach, body of the stomach, greater curve of the stomach, lesser curve of the stomach, incisura, antrum, prepyloric region, pylorus, duodenal bulb, 1st part of the duodenum and 2nd part of the duodenum appeared normal. PEG-G tube successfully placed in the body of the stomach using a deformable internal bolster via the pull technique after the site was identified via transillumination, visualized indentation and needle passed through abdominal wall; distance from external bolster to external end of tube: 3 cm; scope reinserted to confirm placement Staff/Assistant(s) Staff Role RN Other CRNA Other Other MD Other Disposition: PACU - hemodynamically stable. Condition: stable Attending Attestation: I performed the entire procedure. CT abdomen pelvis without contrast Result Date: 4/15/2021 PROCEDURE INFORMATION: Exam: CT Abdomen And Pelvis Without Contrast Exam date and time: 4/15/2021 12:00 AM Age: 65 years old Clinical indication: Other: Na; Additional info: Distention, fungemia workup. TECHNIQUE: Imaging protocol: Computed tomography of the abdomen and pelvis without contrast. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: No relevant prior studies available. FINDINGS: Tubes, catheters and devices: Small bowel feeding tube noted. Lungs: Bibasilar patchy nodular airspace disease with ground-glass opacity. Liver: Normal. No mass. Gallbladder and bile ducts: Multiple gallstones. Pancreas: Normal. No ductal dilation. Spleen: Normal. No splenomegaly. Adrenal glands: Normal. No mass. Kidneys and ureters: Bilateral renal vascular calcifications. Stomach and bowel: Visualized bowels demonstrated a generalized constipation. Appendix: Not well seen. Intraperitoneal space: Unremarkable. No free air. No significant fluid collection. Vasculature: Moderate atherosclerotic changes. Lymph nodes: Unremarkable. No enlarged lymph nodes. Urinary bladder: Unremarkable as visualized. Reproductive: Unremarkable as visualized. Bones/joints: Degenerative changes within the lumbar spine. Soft tissues: Unremarkable. IMPRESSION: Bibasilar nodular airspace disease with ground-glass opacity. No other acute inflammatory process or obstructive uropathy within the abdomen and pelvis. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray abdomen 1 view Result Date: 5/4/2021 XR ABDOMEN 1 VW PORT IMPRESSION: Weighted enteric tube with the tip in the gastric antrum. Residual oral contrast throughout a nondilated colon. END OF IMPRESSION: INDICATION: ng tube placement ng tube placement. TECHNIQUE: AP supine portable projection of the abdomen was acquired. COMPARISON: AP abdomen on 4/15/2021. FINDINGS: The gas pattern is unremarkable. There is residual oral contrast equally distributed throughout a nondilated colon. There is a new weighted enteric tube with the tip in the gastric antrum. Small right lung base pleural effusion is present. No abnormal mass effect is noted. No significant radiopaque calculus is identified. There are no significant bony findings. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray abdomen 1 view Result Date: 4/15/2021 XR ABDOMEN 1 VW PORT IMPRESSION: Orogastric tube is in the stomach. Nonspecific bowel gas pattern. END OF IMPRESSION: INDICATION: Feeding tube placement. TECHNIQUE: Single view of the abdomen. COMPARISON: Prior examination of April 15, 2020. FINDINGS: Orogastric tube is in the stomach. Nonspecific bowel gas pattern is noted. Osseous skeleton is grossly intact. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. CT head without contrast Result Date: 4/21/2021 CT HEAD WO CONTRAST IMPRESSION: No acute intracranial pathology. Mucoperiosteal thickening in the ethmoid sinuses as well as some opacification of the bilateral mastoid air cells consistent with chronic sinus disease and mastoiditis. END OF IMPRESSION: INDICATION: DYSPHAGIA DYSPHAGIA. TECHNIQUE: Spiral CT scan through the head from the skull base through the vertex was performed with 5 mm axial reconstructions. Images obtained without contrast. CONTRAST: No contrast was administered. COMPARISON: April 13, 2021 FINDINGS: No acute hemorrhage, mass, or mass effect. No abnormal extra-axial fluid collections are identified. There is preservation the gray-white differentiation. No evidence to suggest large vascular distribution infarct. The ventricles, cisterns, and other CSF containing spaces demonstrate normal size, shape, and configuration. The basal cisterns are patent and symmetric. Stable focal area of gliosis in the right frontal white matter. The calvarium is intact. The visualized portions the aerated paranasal sinuses mastoid air cells demonstrate bilateral ethmoid sinus mucoperiosteal thickening. Additionally there is scattered opacification of some mastoid air cells bilaterally. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Fluoroscopy video swallow with speech therapy Result Date: 4/19/2021 FL VIDEO SWALLOW WITH SPEECH THERAPY MBSS IMPRESSION: Aspiration of thin and nectar thick liquid. Please refer to speech therapy report. END OF IMPRESSION: INDICATION: Dysphagia. Concern for aspiration. Covid 19. SUPERVISION: Procedure was performed by RRA under direct supervision by MD TECHNIQUE: Fluoroscopy assistance was provided to the speech pathology department. Multiple consistencies of barium and food products were administered to the patient. Fluoroscopy of the oral and pharyngeal region was performed. FLUOROSCOPY TIME: 1.1 minutes COMPARISON: Modified barium swallow of 4/12/2021. FINDINGS: Aspiration of thin and nectar thick fluid. Hypopharyngeal residue with all trials provided. Significant dry secretions in the oral cavity and pharynx. Please see speech pathologist's report for further details and recommendations. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Fluoro NG long tube placement Result Date: 4/30/2021 FL NG LONG TUBE PLACEMENT IMPRESSION: Successful fluoroscopically guided Dobbhoff placement. END OF IMPRESSION: INDICATION: Dobbhoff placement. SUPERVISION: Procedure was performed by staff member under personal supervision by Dr.. TECHNIQUE: Fluoroscopic guidance for nasogastric tube placement. FLUOROSCOPY TIME: 2.2 minutes COMPARISON: None available. FINDINGS: Using fluoroscopic guidance, a nasogastric tube was placed from the left nares into the stomach. Upon placement of the nasogastric tube, 10 cc of Omnipaque contrast material was injected to confirm placement. Opacification within the stomach was visualized confirming appropriate NG tube placement. There were no intraprocedural complications and the procedure was well tolerated by the patient. The patient was discharged from the imaging department in satisfactory condition. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view Result Date: 4/26/2021 XR CHEST 1 VW PORT IMPRESSION: NG tube in the fundus of stomach left upper abdomen. END OF IMPRESSION: INDICATION: SOB evaluate NGT placement following advancement.. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: 4/26/2021 FINDINGS: NG tube in the fundus of stomach left upper abdomen. Stable diffuse patchy infiltrates both lungs in the upper, mid to lower zones and left effusion. No pneumothorax. The heart size is normal. Rib cage is unremarkable. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view - portable Result Date: 4/26/2021 XR CHEST 1 VW PORT IMPRESSION: 1. Interval increase in diffuse airspace opacity and effusions from prior. 2. NG tube tip in the region of the GE junction. Consider further advancement. END OF IMPRESSION: INDICATION: Hypoxia, acute shortness of breath. TECHNIQUE: Portable AP view of the chest is acquired. COMPARISON: 4/22/2021. FINDINGS: Diffuse airspace opacity and effusions appear mildly increased from prior. The NG tube tip is in the region of GE junction. Recommend further advancement. No pneumothorax is identified. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view Result Date: 4/22/2021 XR CHEST 1 VW PORT IMPRESSION: Persistent diffuse patchy infiltrates bilaterally, consistent with Covid infection. END OF IMPRESSION: INDICATION: hypoxia. Covid 19. TECHNIQUE: AP upright projection of the chest is acquired. COMPARISON: Radiographs of 4/18/2021. FINDINGS: The cardiomediastinal silhouette is unchanged. Persistent diffuse patchy infiltrates bilaterally, consistent with Covid infection. No evidence of pleural effusion or pneumothorax. No significant change compared to prior radiographs. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view, Portable Result Date: 4/18/2021 XR CHEST 1 VW PORT IMPRESSION: Enteric tube extends into the stomach. Tip collimated from view. Multifocal airspace disease, increased slightly since 4/13/2021. END OF IMPRESSION: INDICATION: Verify placement of NG tube. TECHNIQUE: AP upright portable projection of the chest is acquired. COMPARISON: 4/13/2021 FINDINGS: An enteric tube extends into the stomach; the tip is collimated from view. The lungs are symmetrically aerated. Multifocal airspace opacities are slightly increased since 4/13/2021. No pneumothorax or pleural effusion. Cardiomediastinal silhouette is stable. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic echo (TTE) limited Result Date: 4/21/2021 FINALIZED REPORT TWO-DIMENSIONAL ECHOCARDIOGRAPHIC FINDINGS LEFT VENTRICLE: Normal size and function RIGHT VENTRICLE: Normal size and function AORTIC VALVE: Trileaflet sclerotic MITRAL VALVE: Mitral annular calcification TRICUSPID VALVE: Normal PULMONIC VALVE: Not well seen LEFT ATRIUM: Normal size RIGHT ATRIUM: Normal size INTERATRIAL SEPTUM: Intact AORTIC ROOT: Normal size PERICARDIUM: No effusion IVC: Normal size and normal collapse AORTIC ARCH: Not well seen COLOR AND SPECTRAL DOPPLER: PA systolic pressure in the range of 30 mmHg FINAL IMPRESSIONS: This is a technically limited study with poor acoustic windows and poor endocardial border definition. Normal LV size with normal wall thickness. No clear-cut regional wall motion abnormalities. EF 55 to 60% Normal RV size and function Aortic sclerosis Mitral annular calcification No vegetations or a source of fungemia noted Transesophageal echo (TEE) Result Date: 4/30/2021 FINALIZED REPORT TWO-DIMENSIONAL ECHOCARDIOGRAPHIC FINDINGS: INTUBATION: Anesthesia airway management provided by the anesthesiologist. I intubated esophagus myself without difficulty LEFT VENTRICLE: LV cavity size mild LVH normal function EF 55-60 RIGHT VENTRICLE: Normal RV size function AORTIC VALVE: Leaflet no vegetation MITRAL VALVE: Appears normal no vegetation TRICUSPID VALVE: Appears normal no vegetation PULMONIC VALVE: Appears normal no vegetation LEFT ATRIUM: Appears normal RIGHT ATRIUM: Appears normal INTERATRIAL SEPTUM: Intact SVC: Appears normal IVC: Appears normal PERICARDIU no effusion LEFT ATRIAL APPENDAGE: Appears normal PULMONARY VEINS: Not well seen AORTIC ROOT: Appears normal ASCENDING THORACIC AORTA: Appears normal AORTIC ARCH: Appears normal DESCENDING AORTA: Appears normal COLOR AND SPECTRAL DOPPLER: No stenotic regurgitant lesions noted FINAL IMPRESSIONS: No vegetations noted Normal LV cavity size wall thickness function EF 55-60 Normal RV size function No valve abnormalities Ultrasound upper extremity venous right Result Date: 4/24/2021 US UPPER EXTREMITY VENOUS RIGHT IMPRESSION: No DVT identified. Superficial thrombosis identified in the cephalic vein. END OF IMPRESSION: INDICATION: Concern for DVT. TECHNIQUE: Real-time two-dimensional ultrasound of the right upper extremity was performed with grayscale, color and duplex Doppler imaging. Compression and augmentation were performed where possible. Permanently recorded images were obtained and stored. FINDINGS: The internal jugular vein, subclavian vein, axillary vein, brachial veins, basilic vein are normal. They demonstrate normal flow and compressibility. There is a thrombus identified in the right cephalic vein at the mid arm through distal forearm. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. CT angiogram chest pulmonary embolism with and without contrast Result Date: 4/22/2021 CTA CHEST PULMONARY EMBOLISM W WO CONTRAST IMPRESSION: No evidence of pulmonary embolus or right heart strain. Extensive parenchymal consolidation in both lungs, left greater than right consistent with severe pneumonia such as Covid 19 pneumonia. Moderate left-sided small to moderate right sided pleural effusions are seen with associated compressive atelectasis. Enlarged main pulmonary artery which can be seen in the setting of chronic pulmonary hypertension. Interval development of large mediastinal adenopathy particularly in the right paratracheal region and subcarinal region. These may be reactive in nature in the setting of as diffuse pneumonia. Enterogastric tube with the tip extending to just within the stomach. END OF IMPRESSION: INDICATION: pneumonia. Assess for pulmonary artery embolism. TECHNIQUE: Enhanced helical CT scan of the chest was performed from the lung apices to below the diaphragm. 2mm axial reconstruction with MPR coronal, oblique and sagittal images were created. 3D shaded surface images also created on a separate workstation and permanently stored. CONTRAST: 100mL of IOHEXOL 350 MG IODINE/ML INTRAVENOUS SOLUTION administered INTRAVENOUS. Quality of contrast opacification was adequate. COMPARISON: July 22, 2013 FINDINGS: Lung windows demonstrate extensive consolidation involving the lungs, left greater than right. There is a moderate left-sided effusion and a small to moderate right sided effusion with associated compressive atelectasis. The trachea and bronchi are grossly unremarkable. No endobronchial lesions are seen. Soft tissue windows demonstrate a grossly unremarkable thoracic inlet. The thyroid is unremarkable. Moderate bilateral axillary lymph nodes are seen with extensive bulky adenopathy in the mediastinum to include the right paratracheal region as well as the subcarinal region and to a lesser extent the hila. The largest lymph nodes are seen in the paratracheal chain demonstrating short axis of approximately 15 mm. Smaller lymph nodes are seen in the aortopulmonary window. These may be reactive in nature. The heart demonstrates a normal configuration. No right heart enlargement is seen. No pericardial effusion is seen. The thoracic aorta and great vessels demonstrate normal branching pattern. Normal course and caliber is seen. The pulmonary arteries demonstrate normal course. There is moderate dilation of the main pulmonary artery up to 3.2 cm. This can be seen in the setting of chronic pulmonary arterial hypertension. No filling defects are seen. Enterogastric tube is seen with the distal tip extending to just within the proximal stomach. The visualized portions of the upper abdomen are grossly unremarkable. The surrounding osseous structures demonstrate mild degenerative changes of the thoracic spine. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.
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| 65 | 2021-05-21 | thinking abnormal |
Throat was swollen, started having anaphylaxis; Throat was swollen, started having anaphylaxis; Bloo...
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Throat was swollen, started having anaphylaxis; Throat was swollen, started having anaphylaxis; Blood pressure got totally out of control, it just spiked; had like a fever; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; got a very bad headache; nausea; chills; Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0162 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Apr2021 09:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. Medical history included blood pressure, patient had anaphylaxis to other drugs in the past, the medication was an ace inhibitor caller took years ago when trying to help blood pressure. Family Medical History provided as "no". Concomitant medications included losartan for blood pressure (patient had been on this medication for years); and progesterone (began taking this medication probably last summer). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153 and expiration date not provided), via an unspecified route of administration, in left arm, on 05Apr2021 13:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. The patient got a very bad headache from 26Apr2021 (about an hour after received second vaccine); nausea from 26Apr2021; chills from 26Apr2021; brain fog from 26Apr2021; fatigue from 26Apr2021; throat was swollen, started having anaphylaxis from 28Apr2021 (in the evening) to 02May2021 (it had eased up enough and patient could swallow); blood pressure got totally out of control, it just spiked from 28Apr2021, patient was still having trouble getting it back down. Patient had to double up on blood pressure medication. Patient stated it was persisting a little bit. Patient's blood pressure was going way higher than what it would normally. Patient only took 25mg of losartan. Patient's blood pressure usually never went over 125. Injection site turned red, swollen, "angry", itching and had like a fever from 28Apr2021. On 26Apr2021, patient got a very bad headache, nausea, chills and fatigue. Patient was expecting all of this. Patient was sick on 26Apr2021 and 27Apr2021 and had to stay in bed, clarified she was sick with headache, chills and fatigue. On 28Apr2021 (Wednesday), patient's throat was swollen, started having anaphylaxis. The outcome of the events "headache, nausea, chills, brain fog" was recovered on 27Apr2021; of "fatigue" was recovering; of "throat was swollen, started having anaphylaxis" was recovered on 02May2021; of "blood pressure got totally out of control, it just spiked" was not recovered; of "injection site turned red, swollen, angry, itching and had like a fever" was recovered on 03May2021.
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| 65 | 2021-05-24 | insomnia, feeling abnormal |
Hips were sore and achy.; Hips were sore and achy.; She was exhausted; Restless sleep; Diarrhea; Fel...
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Hips were sore and achy.; Hips were sore and achy.; She was exhausted; Restless sleep; Diarrhea; Felt a little different; her cheeks were the reddest red she has ever seen; top of her head felt like a plate was on it; This is a spontaneous report from a contactable consumer (reported for himself). A 65-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL8982) administered in left arm via intramuscular route on 20Jan2021 at 09:20am as SINGLE DOSE for covid-19 vaccination. Medical history included family history of Asthma, Thyroidectomy in 2008, Parathyroid disorder. Concomitant medications included Levothyroxine (LEVOTHYROXINE) (100mcg by mouth in the morning) from 2008 as ongoing, Calcitriol (CALCITRIOL) (0.5 mcg daily by mouth) 2008 as ongoing, Calcium Citrate (CALCIUM CITRATE) (1000 mg once a day by mouth) as ongoing. It was reported that parathyroid never returned and patient has to take calcitriol. On an unknown date, the patient experienced hips were sore and achy, she was exhausted and restless sleep. The outcome of the events was unknown. On 20Jan2021, the patient cheeks were the reddest red she has ever seen and top of her head felt like a plate was on it and Felt a little different. The events were recovered on 21Jan2021. On 21Jan2021, the patient had diarrhea. The event diarrhea was recovered in Jan2021. It was reported that the patient received her first dose 20Jan2021 at 9:20am, about 10 hours later at 7:30pm patient reports that the top of her head felt funny, don't know how to describe it. Patient felt like a lid was on head and she would not describe it like a headache. Patient also had flushing of her cheeks stating they were very red, and patient was lit up like a tree. Patient treated this with a cold rag. Patient reports that did not have any of the following event's nausea, fainting, fever, chills, swelling, or welps. Patient took 2 Tylenol to treat the redness, and had a restless night of sleep, upon waking in the middle of the night, the flushing had subsided along with the head symptoms. In the days following vaccination, patient reported 3 days of bad diarrhea. Patient also states she was relatively healthy and active, but her hips were sore and achy after vaccination, but she powered through her 30-minute walk, anyway. Patient wants to know should she receive the second dose of the vaccine as scheduled on 10Feb2021 and should she expect the same AE's. How can she treat them and does she need an Epipen or should she take Benadryl. It was reported that patient received the first dose a week ago as of Wednesday on the 20Jan2021 and in 3 weeks patient was scheduled to revaccinate with the 2nd dose on 10Feb2021. Patient considers a reaction something that happens within 30 minutes of getting a medication and a side effect is something that happens after that. patient reported that she received the first dose on 20Jan2021at 09:20am and exactly 10 hours later that night, patient felt a little different and the very top of her head felt like a plate was on it. It was like a headache, stated that was a little pressure. Patient stated that her cheeks were the reddest red she has ever seen. Patient did not feel like she had a fever or was chilly. She said that her cheeks were flushed. Patient was worried about and has heard about people that have died, gotten bell's palsy, and had strokes. No further details provided. Patient said that she also had diarrhea for about 3-4 days that was pretty bad and drinks lemon water constantly anyway. Patient said that she took 2 Tylenol to treat herself and went to bed and woke up a hour to 1.5 later. The redness in her cheeks were gone. Patient said that she had no shortness of breath, no fever, and no chills. Patient was just scared what would happen next. She was exhausted and thought rest would help her. Patient reported that she still had the feeling in the top of her head at that time she did not sleep well because she was worried. Patient describe it as a restless sleep. Patient stated that the only other thing she noticed was her hip joint were achy. When she got up the next day, patient realized the top of her head and feeling different resolved on 21Jan2021. Diarrhea resolved in the last 2-3 days. Patient ate and drank a lot of liquids and takes vitamins and described them as really good liquid vitamins and she stopped taking it 2 weeks prior to the vaccine and just ate well instead. Follow-up attempts were completed. No further information was expected.
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| 65 | 2021-05-25 | fear, feeling abnormal |
seizure like activity; it was very frightening for her; slurred speech and could not talk; more she ...
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seizure like activity; it was very frightening for her; slurred speech and could not talk; more she started to talk the more slurred her speech got; slurred speech and could not talk; more she started to talk the more slurred her speech got; her tongue started feeling funny; On 19Mar2021 I had weakness in left arm radiating up to left side of neck on left side; went back to get the second one and they wouldn't give it to her; told to seek medical advice; he seizure activity occurred and it was like she had not taken her medicine.; This is a spontaneous report from a contactable consumer. This 65-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6205, Expiry date: Unknown) via unspecified route of administration in left arm on 19Mar2021 at 13:15 (at age of 65-year-old) as a single dose for COVID-19 immunisation. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity): history of partial seizures and migraine headaches since 1996. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination: Yes (Topomax). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had known allergies (but not specified). The patient not received other vaccine in 4 weeks. Concomitant medication include Topomax 50 mg one tablet twice daily for partial seizures and migraine headaches (Batch number: 20EG075 and expiry date Mar2022). No further details provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. On 19Mar2021, at 13:15, the patient experienced seizure like activity, patient was very frightened, slurred speech and could not talk, more she started to talk the more slurred her speech got, her tongue started feeling funny, weakness in left arm radiating up to left side of neck on left side. The patient took her medication that morning and it was like she hadn't taken it. The patient went back to get the second one and they wouldn't give it to her and said to seek medical advice. After vaccination, immediately after the injection she felt the medication radiating in the arm and going up the left side of the neck and then her tongue started feeling funny. On 19Mar2021, the patient had weakness in left arm radiating up to left side of neck on left side, and slurred speech and could not speak immediately after getting Pfizer Covid 19 vaccine. She told nurse and they had waited another 15 min, and when it was over she felt like she had woke up refreshed and awake but it bothered me. The patient took medication to help and after getting the Pfizer Covid 19 vaccine 1st dose my medicine did not seem to be working on 19Mar2021 and continue to date. The patient received the first dose of the Covid vaccine and it appears to had given her seizure like activity and had explained all of that on the application. It was very frightening for her. Her doctor sent her for MRI/MRA testing and she does not know why she went into this as soon as she was given the Covid vaccine. She does take an anticonvulsant for partial seizures as well as migraine headaches and takes that everyday. Took her medicine that morning and it was just like she hadn't taken it. When she takes the anticonvulsant she doesn't have a problem, but after given the Covid vaccine immediately afterwards the seizure activity occurred and it was like she had not taken her medicine. Does not know what to do, she went back to get the second one and they wouldn't give it to her and advised her to get medical advice and then she would have to wait 30 minutes instead of the 15 minutes since having that reaction. The patient wanted to know if she should get second dose. That day she was observed and told to wait 30 minutes instead of the 15minutes until everything subsided. Immediately afterwards she had slurred speech and could not talk and was told if she was not okay they would send her to the emergency room. Had the seizure immediately afterwards before she could get to the waiting area. Went to see the neurologist yesterday and they want to see her back in 4 months. Does not provide manufacture and states she has been on Topamax for years and has had this condition since 1996. Also mentions on bottle she saw a S/N and GTIN, but does not provide any further details. The patient had gotten the results from the MRI/MRI and had the testing done on 30Apr2021. Again mentioned that immediately after the injection she could feel the medication radiating in her arm and going up the left side of her neck and then her tongue started feeling funny. The more she started to talk the more slurred her speech got. Caller stated she has already completed a vaccine adverse event application online on 09Apr2021 and provides reference: DFB2A40A-8C82-4220-B77E-F0A0F1C1F89E. The Outcome of the event weakness in left arm radiating up to left side of neck on left side was unknown and went back to get the second one and they wouldn't give it to her; told to seek medical advice was not recovered, feel the medication radiating in the arm and going up the left side of the neck and then her tongue started feeling funny/took her medication that morning and it was like she hadn't taken it, slurred speech and could not talk; more she started to talk the more slurred her speech got, it was very frightening for her and seizure like activity was recovering. Follow up needed, further information has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of Seizures , dysarthria, Aphasia and other event cannot be excluded. But also consider medical history of partial seizure. however, the reported event of fear is consider as a consequence of seizure that patient experienced and not related to the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-05-26 | anxiety, depression, disturbance in attention, feeling abnormal, memory impairment, sleep disorder, crying, confusional state |
Flare-up of Lyme including flu-like symptoms, fatigue, malaise, no stamina, dysesthesia (burning, ti...
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Flare-up of Lyme including flu-like symptoms, fatigue, malaise, no stamina, dysesthesia (burning, tingling, stinging, tickling, cold, numbness and pain), swollen lymph nodes, swollen knees and ankles, hand and knee pain, numbness (buttocks, and thighs), excruciating pain in left thigh that wakes me from a sound sleep, spasms in neck, bloating, gas, gut noises and discomfort, headaches, depression, anxiety, crying spells, withdrawal, loss of focus, confusion, slow processing (brain fog), slow retrieval, forgetting, incorrect word use, incorrect letter use (writing)
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| 65 | 2021-05-26 | feeling abnormal |
I was tired all the time; head ache; not hunger; lost 14 lbs; I didn't want to get out of bed/I didn...
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I was tired all the time; head ache; not hunger; lost 14 lbs; I didn't want to get out of bed/I didn't have any will to do anything.A shower was an effort; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- er8736), via an unspecified route of administration on 26Apr2021 13:00 (at the age of 65-years-old) as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination the patient was not diagnosed with COVID-19. The patient reported that she didn't want to get out of bed, was tired all the time, headache, not hunger, lot 14 lbs, did not have the will to do anything and a shower was an effort on 27Apr2021 08:00 AM. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 05May2021. The outcome of the events was recovering.
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| 65 | 2021-05-26 | loss of personal independence in daily activities |
Symptoms: Bilateral Trochanteric Bursitis and Bilateral IT Bands tenderness. I had taken a Medrol p...
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Symptoms: Bilateral Trochanteric Bursitis and Bilateral IT Bands tenderness. I had taken a Medrol pack for a week with mild relief. I rested them, but walking, standing after being seated for a while, steps, treadmill dancing, all these things I use to do are now painful. They are not getting better. I spoke to 2 others with this problem. Tender to touch. I can't dance Salsa or Bachatta now, as I had.
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| 65 | 2021-05-26 | memory impairment |
Memory problems, nausea that still continues. Had headaches, fever, and vomitting for one week afte...
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Memory problems, nausea that still continues. Had headaches, fever, and vomitting for one week after 2nd shot.
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| 65 | 2021-05-27 | excessive sleepiness |
she slowly declined with pneumonia; Woozy/Dizzy; Sleeping all the time; Not eating; Running a fever ...
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she slowly declined with pneumonia; Woozy/Dizzy; Sleeping all the time; Not eating; Running a fever off and on; Her blood pressure was a bit low, 105 over something; suspected COVID-19 with symptoms; Heart attack; This is a spontaneous report from Pfizer from a contactable Consumer reported for mother. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The cancer doctor told her that she needed a Covid vaccine since she has cancer and a lowered immune system. Medical history included Metastatic rectal cancer from Jul2019 to 17May2021, Osteoporosis from unknown date to 17May2021 (She had it for maybe 10 years or something), Fibromyalgia from unknown date to 17May2021 (She had the fibromyalgia for 20 years). She had rectal cancer, osteoporosis, fibromyalgia, and a couple other things that the caller can't think of off hand. Her mother was diagnosed with the rectal cancer in Jul2019. The caller has no idea when she was diagnosed with the osteoporosis. She had the fibromyalgia for 20 years, and the caller is sure it was the same for the osteoporosis, maybe 10 years or something. They were being managed. There were no concomitant medications. The patient did have metastatic rectal cancer, but it was managed. She was not on hospice or terminal, and they hadn't exhausted all of the treatment plans yet. It was being controlled. She was under the surveillance of a cancer doctor who was completely shocked by her sudden death. It seemed like there was no reason. She was fine and drove herself to her appointments all the time. She had just driven herself to her last appointment. She passed away yesterday morning. She was slowly declining since she got the vaccine. The coroner was playing guessing games and assumed it was pancreatic cancer. Well, she didn't have pancreatic cancer, and the doctor already said the cancer didn't kill her. The doctor said if he had to guess it could have been some kind of pneumonia or a reaction to the vaccine. All of it made her heart stop. The coroner couldn't get the city to approve an autopsy to see the real cause of death because there was no foul play. The caller took it upon herself to discover if maybe Pfizer could help, and she needs to alleviate the vaccine as an option if it contributed. She is so tired and hasn't slept. It is devastating. This woman was everything in her life, and the caller is probably going to go next with how she feels. She feels responsible. Her other guess is if she gave her mother Covid and she slowly declined with pneumonia. The caller couldn't get her sister to take her mother to the ER. Her sister was there Sunday night. On Monday morning her sister called to say her mother was gone. On 05May2021 the patient had the first dose of the Covid vaccine. The caller could have gone there or called an ambulance when her mother wasn't answering the phone. She knew something was wrong. She called her sister who said their mother wasn't feeling good. Her mother was woozy, dizzy, and sleeping all the time. On day 3, Sunday, the caller couldn't get her mother on the phone. She thought she had some level of peace because her sister was there and could keep her updated. Her mother often gets sickly, but she always answers the phone even if she is deathly sick. The caller thought enough is enough and she needed to be put on the phone on speaker with her mother. The caller's sister said her mother was sleeping. The doctor said to probably bring her mother to the ER. The caller told her sister who just didn't take her mother to the ER. The caller could have called an ambulance. She feels incompetent. They are assuming the cause of death was a heart attack. If her mother had gone to the ER on Sunday night they may have found out. Her mother became woozy last weekend because the caller was there on Thursday and her mother didn't look good. She had her chemo bag because she brings it home. It was her first new chemo treatment, and the caller had never seen her mother respond like this. It was strange. Any other time when she was getting chemo she felt great because there is so much stuff in there like steroids to prevent a reaction. It was surprising because she was only sick on chemo once and she had been on this one before. She was just off. Then she continued to decline from there. It started before the chemo. She got on chemo that Thursday before Mother's Day, she was on her first chemo treatment at that time. She was sick a couple of days before that. She had the chemo on 06May2021. She started feeling sickly the day she got the injection on 05May2021. When the caller was there she was thinking it was from the chemo. The caller calls her mother every day and she was sounding worse and worse. On Thursday 13May2021 her mother took herself to her chemo follow up appointment and was telling the doctor that she was woozy, dizzy, and not eating. The doctor gave her fluids, and he didn't give her chemo because she was not scheduled for it that day. It was just a follow up appointment. He sent her home. The caller talked to her mother on Thursday evening and she didn't sound good and told her she was woozy and dizzy. On Friday, Saturday, and Sunday she didn't answer the phone. The caller's mother is totally against vaccines, and she had been begged to get the pneumonia and flu vaccine and denied them. She had never responded well to them in her life. Even as a cancer patient they would say she needed it and she wouldn't. She did get the Covid vaccine even though she didn't want to. The caller thought her mother was trying to convince herself it was because of the vaccine because she is so against them, but now she doesn't know. The doctor said he didn't think it would have been Covid because she didn't have a fever. Her mother told her that she had been running a fever off and on, which is not unusual for her mother. The doctor didn't think it would have been Covid. Her mother started sleeping all the time mid week last week. She started not eating at the end of last week. The caller has no idea when her mother had a fever. She hadn't gotten to talk to her mother all weekend. At some point last week her mother had said in a conversation that she had a fever off and on. Then on Thursday when she went to the chemo doctor she had no fever it shows it was 97 something. Her oxygen was fine. Her blood pressure was a bit low, 105 over something, which is low for her. She didn't have a fever last Thursday. Prior Vaccinations within 4 weeks no other vaccinations. Blood work on 13May2021 with unknown result. The patient passed away on 17May2021 after receiving the first dose of the Pfizer Covid vaccine. The caller expresses concern that her mother may have had Covid. No autopsy done. Cause of death was Heart attack. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: Heart attack
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| 65 | 2021-05-31 | feeling abnormal |
Day of the vaccine the body felt different, when home the arm was in pain for a day or two. By Frida...
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Day of the vaccine the body felt different, when home the arm was in pain for a day or two. By Friday even there was a headache and on Saturday it was worse. The doctor friend said to take Tylenol and lay down. On Sunday the left ear was swelling and the left side of the face was swelling. The doctor friend continued to recommend the Tylenol. The following Wednesday the sister took her to the hospital. The hospital said the face was disfigured and told her she has Bell Parsley. She will need to see an ear specialist. Her eyes were affecting her.
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| 65 | 2021-06-01 | loss of personal independence in daily activities, hallucination, memory impairment |
She started having delusions and hallucinations, body tremors like epileptic seizure, she was fallin...
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She started having delusions and hallucinations, body tremors like epileptic seizure, she was falling down and using the bathroom on herself, her walk was a shuffled gate, she didn't remember almost 3 months in hospital, coma for 5 days and had a mini stroke. Her psych doctor thought maybe the vaccine could have triggered this type of reaction. She gained consciousness and was sent to a rehab nursing home where she's learning to walk to feed herself and getting stronger now that she's home. There's a long road to recovery.
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| 65 | 2021-06-02 | confusional state |
Pt's son reported pt became short of breath and confused while in the waiting area after receiving v...
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Pt's son reported pt became short of breath and confused while in the waiting area after receiving vaccine. Upon assessment, pt was hypotensive at 90/60 with O2 sat of 91% on room air. EMS called and provided pt with oxygen via nasal cannula. Pt transported to hospital for further evaluation.
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| 65 | 2021-06-02 | depression, anxiety |
Depression and anxiety, body aches, headache - it happened 9 days after my second shot... so I was s...
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Depression and anxiety, body aches, headache - it happened 9 days after my second shot... so I was surprised, had not expected it and worried I'd gotten covid before my second shot had built immunity. The depression was most troublesome though since it had not been reported as a potential side effect and because I have a history of depression,.. and I have such a concern about losing my ability to function due to depression. The body symtpoms have gone, but I've had some recurring periods of depression. I'm confident my depression is related to inflammation (any kind of infection sets it off), so the thought of a "cytokine storm" with covid, would have certainly killed me (through suicide if not respiratory illness). Knowing what to expect is 2/3 the battle, so I hope you can figure out what the broader pattern is, how long it lasts, and is there anything we can do about it. For myself, I increased my fish oil to 6 grams (pure EPA) and NAC to 6 grams as well, plus additional Tumeric... all things that help with inflammation (not motrin tho, it can make it worse). Best of luck to you. Do let me know if you need further information.
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| 65 | 2021-06-02 | insomnia |
1st Covid shot had extreme pain in left arm and couldn't sleep, had to take tylenol. Experienced sh...
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1st Covid shot had extreme pain in left arm and couldn't sleep, had to take tylenol. Experienced short dizziness episodes but on March 18 and 19 had nausea. After the 2nd covid vaccine my left arm hurt but pain went away after third day but periods of dizziness continued for a couple of weeks. During month of April had increase of pain in pelvic area and lower back. In May spasms in pelvic area which got worse. couldn't sleep by May 24 and called 911 togotothe Emergency Room
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| 65 | 2021-06-02 | insomnia |
Sleeplessness; This is a spontaneous report from a contactable Other-HCP (patient). A 65-years-non p...
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Sleeplessness; This is a spontaneous report from a contactable Other-HCP (patient). A 65-years-non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration in Arm Left on 22Feb2021 as single dose for covid-19 immunization. Facility type vaccine was School or Student Health Clinic. Patient medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. Historical vaccination included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration in arm right on 01Feb2021 at 10:00 as single dose for covid-19 immunization. Concomitant medication included vitamin D nos (VITAMIN D NOS) and vitamin B nos (VITAMIN B NOS) within 2 weeks of vaccination. The patient has allergies to sodium lauryl sulfate. It was reported that Sleeplessness starting about 8 days after shot two. Not consuming any caffeine or alcohol. Adverse event date was reported as 27Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Pcr test): negative on 24Feb2021. Patient didn't receive any treatment for event. Outcome of the event were not recovered. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-06-03 | feeling abnormal |
felt dizzy; a fuzzy feeling; This is a spontaneous report from a contactable consumer. A 65-years-...
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felt dizzy; a fuzzy feeling; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200) on 01Mar2021 at 14:00 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included high blood pressure. On 04Feb2021 the patient received pneumococcal vaccine in right arm. Concomitant medications included metroprolol, losartan, VITAMIN D3, psyllium hydrophilic mucilloid (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID). The patient informed that on 01Mar2011 after taking Vitamin D3-2000IU approximately 5 hours after vaccination felt dizzy and a fuzzy feeling for about 10 minutes, drank 2 glasses of water and the feeling stopped. The patient reported she had not taken the vitamin D3 since. The patient recovered from the event on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-06-07 | excessive sleepiness |
She got her vaccine, she got very weak and tired and slept the first day and a half as she was so we...
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She got her vaccine, she got very weak and tired and slept the first day and a half as she was so weak and tired and had a headache. The headache went away after the 3rd day, but the tiredness lasted for about a month or so. She found it more difficult to breath. Prior to this she had some problems breathing, but it got worse after she received the vaccine, pretty much right away. She went to her doctor who sent her to a pulmonologist. The pulmonologist sent her for a pulmonary function tests, and had a test that her oxygen dropped to 86 when she was walking. In November she was having problems, and had a chest x-ray and did not get back to her until 2/8/21 and that she had an enlarged heart, but it got worse after the vaccine. She was placed on oxygen on 3/26/21. This has helped her. She was not put on any nebulizers as they did not help much and is on Oxygen 24/7. The tightness in her chest have gone away but does have occasional headaches possibly due to not using her oxygen at times.
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| 65 | 2021-06-08 | panic reaction |
Neck turned pink; Sweating profusely; Prickly feeling on the neck; Sore on the injection site/arm wa...
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Neck turned pink; Sweating profusely; Prickly feeling on the neck; Sore on the injection site/arm was a little sore; A little bit of effort to swallow; panicking; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 17Feb2021 (at the age of 65-year-old) (Batch/Lot Number: EN6200) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history includes allergy to penicillin so she does not take penicillin. The reaction was years ago and it was a rash all over her body. The patient's concomitant medications were not reported. Historical vaccine includes flu shot, Dtap and pneumonia; all on an unspecified date for immunisation. The patient reported that her neck turned pink, sweating profusely, prickly feeling on the neck, sore on the injection site but never lasted for so long, and a little bit of effort to swallow. All events started on 18Feb2021. Her doctor advised her to take Benadryl, she took 2 tablets and symptoms were gone. Patient spoke with her internist and allergist about taking the 2nd dose. It was also reported that patient saw her doctor and couldn't really figure out what happened. She believes it was a type of allergic reaction. Her neck on the side, the sides of her neck, turned pink, like she had a sunburn. She was sweating profusely. She had a prickly feeling on the neck. She didn't have Covid symptoms at all, but had a little soreness in her arm from the injection itself. It didn't happen until the next day. The doctor told her to take Benadryl and it subsided. When the Benadryl wore off, the symptoms came back so she took more Benadryl. It was gone now and never came back. She called and wanted to know if Pfizer was doing a clinical trial on people who had a reaction to the first shot. She wanted to know if she should get second shot. Her doctor told her wait until more data was collected before receiving shot number 2. The patient also stated that she has been doing research and according CDC there are 2 types of allergic reactions. One was severe, requiring medical attention. Immediate, that happen within first 4 hours. It didn't happen in the first 4 hours so it wasn't immediate. She called her doctor over the ensuing days. She stated hers wasn't severe enough. She stated she did call and speak to doctor, but she didn't have to go to an emergency room. The shot was at about 11am. The symptoms happened 30 to 36 hours after receiving shot. The patient also stated that she also filed a VAERS report online for people with an allergic reaction to anything. Furthermore, sore arm didn't last much at all. She didn't have the reaction most people have. The only other symptom and she can't tell if it was nerves. But she had to have some effort to swallow, it may have been due to her panicking at that point because of being alone in the house and having reaction. Her reaction occurred on 18Feb2021 and she took Benadryl for two days. She kept taking the Benadryl until symptoms were all gone. By Saturday she felt perfectly fine again and she stopped taking it. Additionally, she stated that sweating was the worst on the 18th. It was like she was running a marathon. She was dripping. Her clothes were sticking to her, she had to change her clothing. She was really sweating. She was wearing camisole under blouse and the camisole was getting drenched so she changed her top and did not have to change top again. She also stated that for prickly feeling on the neck, she was taking Benadryl every 4-6 hours. Her symptoms weren't at full force. She was trying to keep her symptoms down and not let them come back at full force. It was better when taking Benadryl, but didn't fully go away until Saturday. Also, arm was a little sore from injection itself and that didn't last much at all. It didn't stop her from doing any activity. She has delivered two children without having medication so she knows levels of pain. The arm stayed sore for more days than her other symptoms. She had no inflammation. It was not red and there was no bump. She was worried about other things. The patient further clarified Benadryl product name as Diphenhydramine 25 mg, ultra tabs, took two (count size dispensed: 48 tablets). She took it every 4 hours during the day, and every 6 hours at night. She doesn't sleep more than 6 hours. When she woke up, she would take another two tablets. It was working. She does not have lot number to provide. Everything reduced with Benadryl. Therapeutic measures were taken as a result of all events. On 20Feb2021, the patient recovered from neck turned pink, sweating profusely, and prickly feeling on the neck; recovered from sore on the injection site on 22Feb2021; while outcomes of a little bit of effort to swallow and panicking were unknown.
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| 65 | 2021-06-09 | anxiety, panic attack |
I took my last COVID shot on March 2021 on or abt April 15 I became short of breath and was having p...
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I took my last COVID shot on March 2021 on or abt April 15 I became short of breath and was having panic attacks. I went to doctor and was treated for Aneixty. My symptoms got worst went back to doctor and hospital er. While in the emergency room I was diagnosed w a pulmonary embolism. Never had this no famil issues w blood clots. I was hospitalize for 4 days and put on blood thinners I am still suffering from shortness of breath and panic attacks. I also lost 22 pounds in less than a month based on not being able to eat. This was a nightmare. I feel sure this was a side affect of the COVID shot no one cared to share the risk. This needs to be documented and reported I?m sure there are others.
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| 66 | 2021-01-04 | feeling abnormal |
Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I ...
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Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I get up, I get light headed; I had COVID back in March and I feel the same way I felt then except the breathing is normal; Very weak; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation . Medical history included blood pressure measurement on an unknown date. The patient had been up all night long freezing, shaking; had to take a hot bath just to warm up on 24Dec2020 with outcome of unknown , every time she got up, she got light headed on 24Dec2020 with outcome of unknown , she had Covid back in March and she felt the same way except the breathing is normal on 24Dec2020 with outcome of unknown , very weak on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Mar2020. Information about Lot /batch number has been requested.
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| 66 | 2021-01-04 | feeling abnormal |
66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg ...
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66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating "I just don't feel right". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.
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| 66 | 2021-01-10 | sleep disorder |
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9...
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1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
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| 66 | 2021-01-11 | feeling abnormal |
Seasonal allergy; allergic conjunctivitis; yeast infection; yeast infection; she didnt feel great, s...
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Seasonal allergy; allergic conjunctivitis; yeast infection; yeast infection; she didnt feel great, she was off; grumpy; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK5730 and expiry date: Mar2021), via an unspecified route of administration in arm on 22Dec2020 at single dose for Covid-19 Immunization. Medical history included yeast infection 20 years ago (in 2000). There were no concomitant medications. The patient received her first dose on 22Dec2020. She is due for the second dose on 12Jan2021. She got allergic conjunctivitis on 23Dec2020, yeast infection on unspecified date in Dec2020, and seasonal allergies that were very bad, which doesn't typically happen to her this time of year on 26Dec2020. She had a Covid test that was negative. She wants to know if she should get the second dose. The conjunctivitis was not bad, it stopped after she took out her contacts, used allergy drops and it cleared it up. The last one she had yeast infection was like was 20 years ago, but she treated it herself and it is gone now. She got the conjunctivitis within 24 hours of receiving the first dose, she got the yeast infection 2-3 days after the first dose, and the allergies began about 4 days after the first dose. The conjunctivitis and the yeast infection have both resolved but the allergies are still ongoing, they come and go, the intensity comes and goes, she even checked the pollen count and it was non-existent. She had a Negative Covid Test on 28Dec2020. She had a Negative Antibody Test back in Jun2020. She has had no positive test for Covid prior to getting the vaccine. She has had No issues with vaccines in the past. She stated that she's read all the stuff on the website, and is has the usual stuff, yes her injection site was a little... not bad, she did not feel great, she was off, and grumpy on unspecified date in Dec2020. The events conjunctivitis and the yeast infection resolved on unspecified date; the event seasonal allergy was not recovered; and the remaining events was unknown.
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| 66 | 2021-01-13 | impaired work ability | Myalgia, Nausea Vomiting, Fatigue Missed work following second dose secondary to above symptoms |
| 66 | 2021-01-17 | feeling abnormal, anxiety |
Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea...
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Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain Benadryl 50mgm, Epinephrine, Observation,
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| 66 | 2021-01-20 | anxiety, nervousness |
Patient felt anxious and tightness around her throat. Verbalized she was nervous. Pt. was evaluate...
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Patient felt anxious and tightness around her throat. Verbalized she was nervous. Pt. was evaluated by Fire Rescue, vss nad. Pt. was discharged home and advised to call 911 for worsening symptoms.
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| 66 | 2021-01-26 | anxiety | After administration of vaccine, became short of breath and anxious |
| 66 | 2021-01-26 | excessive sleepiness |
Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A hea...
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Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 66 | 2021-01-27 | nervousness |
Patient got dizzy and hyperventilated (nervous, as friend experienced adverse reaction). Gave water ...
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Patient got dizzy and hyperventilated (nervous, as friend experienced adverse reaction). Gave water and resolved.
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| 66 | 2021-01-27 | panic reaction |
I received the COVID vaccine 1 at 2 PM. At 5:40 PM, the left side of my face was numb. I emailed m...
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I received the COVID vaccine 1 at 2 PM. At 5:40 PM, the left side of my face was numb. I emailed my PCP as to what I should do. She told me to go to Urgent Care as soon as I left work, which I did. Because I had Bell's Palsy two years ago at this time, I panicked. I was told by the Urgent Care doctor that numbness is a common side effect (which I had not previously read like I did Bell's Palsy) and the numbness would subside in about a week. She told me to complete this report.
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| 66 | 2021-01-29 | sleep disorder |
The night of the shot I got very little sleep due to my entire right arm which took the shot aching ...
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The night of the shot I got very little sleep due to my entire right arm which took the shot aching and hurting all night til I got up the next morning. Have had not other symptoms but it did scare me that night. My husband experienced soreness of the arm and fatigue.
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| 66 | 2021-01-31 | anxiety |
Pt. Reports ?warm tingle? in chest, back of neck, L arm. V/S 120/80-BP, 88-HR, 98%-O2, 20-resp. Pt. ...
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Pt. Reports ?warm tingle? in chest, back of neck, L arm. V/S 120/80-BP, 88-HR, 98%-O2, 20-resp. Pt. Reports to ?feeling a little anxious? about receiving vaccine. At 10 minutes pt. Reports wariness/tingle was gone. ~20 minutes pt. Reports feeling is now back in opposite are and again in next. V/S 125/80-BP, 85-HR, 98%-O2, 18-resp. ~25 minutes pt. Reports symptoms are again gone. Pt. Education if symptoms return/worsen to seek medical attention. Pt. Expressed understanding.
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| 66 | 2021-02-01 | feeling abnormal |
Short fainting spell; This is a spontaneous report from a contactable consumer (patient). A 66-year-...
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Short fainting spell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1686), intramuscularly on 14Jan2021 after 15:00 (her appointment was at 1510 but she had to wait past her appointment time before she received it) in upper right arm at single dose for Prevent Covid in hospital. No history of all previous immunization with bnt162b2 considered as suspect. No additional vaccines administered on same date of bnt162b2. Medical history included breast cancer from 9 years before 19Jan2021 (2012) and she has been Anastrozole since, she was only supposed to take Anastrozole for 5 years and when she was one month away from being done with it she had a Seizure and she was found to have a Tumor in her brain, she had had Srs surgery on her brain on 13Apr2016, she was prescribed Levetiracetam, a seizure medication, for two years and had not had any problem since. Concomitant medication included ongoing anastrozole taking for about 9 years for Post breast cancer. No prior vaccinations within 4 weeks. The patient previously took levetiracetam for seizure, she stopped taking Levetiracetam 750mg about 2 or 3 years before 19Jan2021, flu shot on 05Dec2020 for immunization at the age of 66-year-old. The patient reported that she had a short fainting spell around 8:30am on 19Jan2021 and she was not sure if it was related to the Covid vaccine. She described that she had been sitting for a while and when she got up she felt like this black curtain coming down which she has felt before in the past but she usually recovered and never lost control to where she fainted. Her husband was there to catch her. She clarified that she never passed out. She did not have any reactions in the past few days since she received the covid vaccine, she did not even have soreness at injection site. The event was not required a visit to Emergency Room nor Physician Office. Relevant Tests was none. The outcome of the event was unknown.
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| 66 | 2021-02-01 | poor quality sleep |
soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going...
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soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization. Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine. The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours. Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious. Information on lot number/batch number was requested. Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
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| 66 | 2021-02-03 | feeling abnormal |
Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood P...
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Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood Pressure Emergency Room High. Fast heartbeat. Dizziness. Weakness. Trouble communicating-at a loss for words. Took Lisinopril-HCTZ20-12.5 while being monitored by RNs for BP and heart rate. 5 minutes thereafter, fuzzy cloud lifted from brain. Eventually felt OK to leave site.
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| 66 | 2021-02-03 | sleep disorder |
Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to ...
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Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to sleep. Headache resolved the next morning. Sore arm resolved in about 2 days
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| 66 | 2021-02-09 | feeling abnormal |
headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontane...
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headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262), via an unspecified route of administration in the left arm on 23Jan2021 10:00, at 0.3ml, single for covid-19 immunization.The patient medical history was not reported. Patient is an Rh Neg A blood type and did not have Covid, as she's been isolated for a year. Concomitant medication included gabapentin, paroxetine hydrochloride and atorvastatin. On 23Ja2021, after half an hour (10:30) of receiving 1st dose of the vaccine, patient experienced heart pounding, racing heart beat, dizziness, feelings of passing out. These symptoms lasted up to 3 hours. Patient sat her my car outside of the an emergency parking lot for 3 hours because she couldn't drive home during these symptoms. Patient was on the verge of going into emergency care. For the remainder of the day, patient's sitting heart beat was at 90. The next day, 24Jan201, she felt better but have on and off slight headache. She did not plan on taking the 2nd dose. The outcome of the events was recovering. The patient has not tested positive for Covid-19 post vaccination.
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| 66 | 2021-02-10 | confusional state |
Ringing in head to the point of distraction and mild confusion , body aches, headache (worse than us...
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Ringing in head to the point of distraction and mild confusion , body aches, headache (worse than usual), dizziness and some queasiness. Fluctuates very bad for 6-12 hours, then slightly better for a few hours, then pattern repeats. Unusual fatigue occasionally but not too severe.
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| 66 | 2021-02-10 | feeling abnormal |
Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwel...
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Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwell, weakness, brain fog, lasted 40 hours.
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| 66 | 2021-02-10 | excessive sleepiness |
3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extr...
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3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extremely tired. Hard time opening my eyes. Moving limbs. Slept 30 hrs.
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| 66 | 2021-02-11 | feeling abnormal, nervousness |
At 4:55, patient received a COVID-19 Pfizer vaccine. At the time of administration patient expressed...
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At 4:55, patient received a COVID-19 Pfizer vaccine. At the time of administration patient expressed she had experienced a previous reaction to a pneumonia vaccination (unknown time frame) and that she did not like to receive shots. She requested that the person administering the vaccine count down before giving shot. Patient appeared nervous and was breathing heavily before she received her vaccine. Patient was instructed to sit and wait 15 mins. after vaccine administration in case of an adverse reaction. At time of check-out from the pharmacy (15 mins. after vaccination), patient expressed to pharmacy intern that she felt a "little dizzy" and that she had experienced "slurred speech" immediately after having received the vaccine, however had not communicated this to pharmacy staff. Pharmacy intern immediately took patients blood pressure and it was 176/99 mmHg and 162/101 mmHg during first two blood pressure checks. The pharmacy staff requested patient to remain within the pharmacy premises so that she could be monitored for more time. She then was checked every 5-10 minutes for approximately 2 hours. During this time, she described vision changes, dizziness, and a strange "fogginess" around her head. Additional blood pressure monitoring was conducted for results of 158/100 mmHg and 195/100 mmHg. Pharmacy Manager discussed options with patient, including having her go to an Urgent Care facility or calling 911, so that paramedics could assess her. patient expressed she wanted to be taken to the hospital, therefore intern called 911. Paramedics arrived shortly after and determined patient had not experienced a stroke. Her neurological exam was negative. Paramedics stated that patient was most likely experiencing an allergic reaction. The paramedics then proceeded to take patient to the hospital at her request around 7:00 PM. Multiple pharmacists and pharmacy interns spoke with her during this time frame of ~2-2.5 hours, took her blood pressure, and assessed her condition.
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| 66 | 2021-02-11 | feeling abnormal | chills, cough, swollen glands in neck, sore throat, just didn't feel right |
| 66 | 2021-02-11 | sensation of foreign body |
Pt was administered COVID-19 Pfizer vaccine on 2/12/2021 at approximately 1415. At 1440 pt was obser...
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Pt was administered COVID-19 Pfizer vaccine on 2/12/2021 at approximately 1415. At 1440 pt was observed to be coughing. Pt stated, "It feels like there is something in my throat". POX remained 98% on RA with HR 105-112. Pt observed by nursing staff until 1445 when she was taken to the ED from the vaccination tent. At this time pt exhibited increasing SOB with notable tongue swelling. Pt reports previous anaphylaxis reaction to bee venom.
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| 66 | 2021-02-12 | confusional state |
18 hours after 2nd dose, severe cramping, diarhhea, sweating. Passed out while on toilet. Came to wi...
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18 hours after 2nd dose, severe cramping, diarhhea, sweating. Passed out while on toilet. Came to with nose bleeding from both nostrils, goose egg on forehead. Husband helped me back on commode, more diarhhea, then threw up 3 times. After 15 minutes, helped back to bed, chills, shakes, fatigue. May have broken/cracked nose and slight concussion - was slightly confused for 24 hours, headaches, unable to wear eyeglasses due to swelling and bruising on nose. Ice pack on nose 4x day for 15 minutes. Tylenol and Ibuprofen for pain. At 60 hours (after injection) welt is fading and not hot, beginning to feel better, although still fatigued, and headaches continue. This description was sent to my doctor.
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| 66 | 2021-02-14 | impaired work ability |
Both times I felt like I had COVID all over again. My whole body hurt so bad. I missed work both tim...
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Both times I felt like I had COVID all over again. My whole body hurt so bad. I missed work both times. I had COVID in November. I experienced fever, chills, body aches.
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| 66 | 2021-02-15 | anxiety |
Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tire...
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Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tired and sleepy. Nausea, weak, headache, feeling unwell. Took a valium to calm down. Felt better around 10 pm on 2/14 but lasted through 2/15. Woke up on 2/16 with my bed soaking wet.
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| 66 | 2021-02-15 | anxiety |
Client attended by onsite EMS. Client concerned about dizziness after receiving COVID-19 vaccine. ...
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Client attended by onsite EMS. Client concerned about dizziness after receiving COVID-19 vaccine. Decided to have bp taken. Pulse/heart rate 107, O2 96%, stated had anxiety.
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| 66 | 2021-02-15 | confusional state |
patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. pat...
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patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. patient wheeled to vaccine waiting room. patient became lethargic and blacked out. patient not alert and awake for approximately 1 minute. patient came to, pulse 80, blood pressure 93/70, oxygen saturation 98%, husband at side, emergency cart and AED and oxygen brought to location of the patient. oxygen 2L nasal canula placed on patient. EMS called and Dr. came to site. assessment obtained with Dr. at site. patient awake, was able to speak full name but stated she was not aware of where she was. this reaction happened approximately 6 minutes post immunization. within approximately 3 minutes of episode where she states she felt she was going to "black out" she began to shake/ full body involvement. during this episode patient was following nurse commands. momements were rhythmic and lasted approximately 10 seconds then stopped. Patient brought back to exam room. at 138pm- temp 97.5, blood pressure 144/31, pulse 51, respiration 18. patient stated she felt warm and reports she felt she was going to black out. this episode lasted approximately 3 seconds and patient became alert at that time. vitals at 140 pm- blood pressure 124/60, pulse 75, respirations 16. vitals at 144pm- blood pressure 119/75, pulse 75, respirations 16. patient has dialysis 4 times a week for CKD stage 5. patient has lengthy medical history. patient reports her primary care doctor is Dr. who sees her frequently. patient reports she has an issue with internal bleeding with source unknown and at times has to have blood transfusions. no recent illnesses reported. patient states she ate breakfast around 10am today. patient states she has never had a vaccine reaction int he past or reaction to needles. EMS arrived on site approximately 1345. report given to EMS. patient alert with EMT. patient transferred from her personal wheelchair to EMS cot. patients husband left with patient to go to Medical Center. Patient tolerated vaccine well immediately after immunization. She reported no pain at injection site. Paper tape and 2x2 gauze placed at injection site due to allergy to tape. Allergy list was reviewed prior to administration of vaccine. Patient alert and oriented prior to vaccine to person place and time. Husband present in room. Verbal consent obtained by patient to receive covid vaccine today . Vaccine information handout and emergency use handout given to patient. Patient wheeled out of exam in wheelchair.
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| 66 | 2021-02-16 | sleep disorder |
Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days ...
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Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days Upper arm still sore after 12 days. Pain on movement and unable to sleep on that side, as the arm pain awakens me. Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
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| 66 | 2021-02-17 | feeling abnormal |
I started experiencing spasms in the right side of my face. I had a weird feeling in my veins that w...
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I started experiencing spasms in the right side of my face. I had a weird feeling in my veins that went up and down my arms and by Saturday it was up in my head. this lasted for 4 hours. I had a bright white light in my right eye that was like a burst of light every time I blink. I went to the eye doctor on 2/5 and they gave me an eye dilation drop and he said that when the lining of the eyeball pulls away from the eyeball it catches the light coming into the eye and reflects down into the eye very bright. I started swelling and had a red rash on my neck, back of my neck, jaw, arms and kegs and belly. it started itching and had raised dots. about 12 dots on each limb/surface. I took Claritin and Famotidine. I woke up with more itching and a cold wave over my body. I took more Claritin and famotidine. My arms, legs, belly, and back started itching again. I had chills. The skin on my arm was hard in spots. I took half a Benadryl on Monday the 8th at 5 am. at 8am I was still itching. it died down but then flared up again and I took Zyrtec at 8pm. Tuesday the 9th I woke at 5am with more itching. I ate food and had more itching. Wednesday I had pain in my jam and my tmj flared up and I had pain in my molar but the Dentist said there was nothing wrong with my tooth. On 2/9 I had a blood draw and everything was normal. the only thing not normal was the carbon dioxide in my system. On 2/16 I was still feeling weird.
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| 66 | 2021-02-17 | sleep disorder |
On a pain scale of 1 to 10, inner aspect of right leg 7 or 8. So weird! Limping. Awakened throughout...
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On a pain scale of 1 to 10, inner aspect of right leg 7 or 8. So weird! Limping. Awakened throughout night with every movement in sleep. This lasted about 48 hours. Pressing inside aspect of right knee shot pain up to 10, radiating down to ankle and up inner thigh. Also had injection site redness, tenderness, and a raised lump, not unexpected. Had some brain fogginess two days post injection as well. No treatment; just time. Note: I'm sure I had Covid-19 in February 2020. No test available then.
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| 66 | 2021-02-18 | sleep disorder |
Beginning about 3 days following 2nd Covid-19 vaccination, experienced onset of nerve pain left side...
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Beginning about 3 days following 2nd Covid-19 vaccination, experienced onset of nerve pain left side of neck, back left shoulder, radiating down left arm. Constant pain - much worse during sleep. Unable to sleep, changing positions little help - better sitting up or in high recline in bed. Treating with Tylenol, Ibupropfen periodically. Applying cold compress and warm compresses alternatively. Tried analgesic cream rub with little success. Able to exercise with little change. Rubbing of neck muscles helps somewhat.
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| 66 | 2021-02-19 | insomnia |
Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and...
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Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and diarrhea were occurring. Those symptoms now resolved but myalgias persist.
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| 66 | 2021-02-21 | feeling abnormal |
Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through th...
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Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.
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| 66 | 2021-02-22 | panic attack |
client says she was in distress prior to taking the vaccine because she had stood for over an hour i...
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client says she was in distress prior to taking the vaccine because she had stood for over an hour in line waiting to be seen and she had a double mask on. She says by then she was dehydrated and feeling faint. She has a history of atrial fib off and on, which she takes medication for. She says she feels like she almost had a stroke and Nurse Pract told her she had a full blown panic attack. She was allowed to sit down and rest and rehydrate and eat and she felt better.
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| 66 | 2021-02-22 | sleep disorder, insomnia, feeling abnormal |
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints ...
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About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
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| 66 | 2021-02-23 | loss of personal independence in daily activities |
The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to tha...
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The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to that dose. (Had arm pain and mild chills and fatigue). The day after dose two above noted fullness and discomfort in feet, On the second day after, had early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize. However, progressed and at 9am on the third day after vaccine started prednisone 40mg. At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
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| 66 | 2021-02-23 | sensation of foreign body |
Within 5 minutes of receiving vaccine, patient developed purplish hands, red blotches on her arms, g...
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Within 5 minutes of receiving vaccine, patient developed purplish hands, red blotches on her arms, generalized itching. She felt thirsty, dry throat and a little bit of fullness in her throat. Throat did not actually close. She felt like she was looking through a fog. She was given oral zyrtec and IM benadryl. Symptoms resolved.
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| 66 | 2021-02-24 | anxiety | Nausea, flushed, feeling anxious, evaluated by EMS-cleared |
| 66 | 2021-02-26 | sleep disorder |
Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank...
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Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank about 20 oz of Crystal Light Peach Tea over night. Got up at 5am to get more to drink and find another place to rest. went into my kitchen to fill container and passed out. Woke a few seconds later. Left side of my forehead was bruised and swollen above left eye. Over the last 4 days both eyes an cheeks are bruised. All day felt like I had the flu without the fever. I did not go to the hospital.
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| 66 | 2021-02-27 | feeling abnormal |
Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and...
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Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and again the day after. Injection site became red and itchy within an hour of injection; redness has spread down the arm and continues to itch on day 3. This did not occur with first jab. Loss of appetite, fatigue, and brain fog, the day of and next day.
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| 66 | 2021-02-27 | insomnia, feeling abnormal |
Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sle...
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Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sleeplessness was worse each night, with inablilty to sleep even with 50 mg of Benadryl and Valium. Did sleep about two hours a night with those meds but continued to be wide awake all day also. My body felt like it hadn't slept but was unable to do so. These symptoms left me suddenly with a severe chill and the brain fog litarally lifted and was gone. The next week following developed mild red itchy skin that comes and goes on hands and torso and that symptom persists. I am now able to sleep.
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| 66 | 2021-02-27 | insomnia |
1st and 2nd night after vaccine had sleeplessness (I do not normally have sleeplessness). 3rd night...
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1st and 2nd night after vaccine had sleeplessness (I do not normally have sleeplessness). 3rd night ok (slept 5 hours before waking). 4th night - worst sleepless thus far: Slept 2 hours and woke up. Went back to sleep, but woke up about every hour for the next 3 hours. Could not get back to sleep after 5 hours.
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| 66 | 2021-02-28 | anxiety, insomnia |
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room....
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Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute. Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer. Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room. Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns. Ate granola, blueberries, yogurt for breakfast this am Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72. No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD Patient alert and oriented during entire visit and pleasant in conversation.
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| 66 | 2021-02-28 | anxiety |
Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occ...
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Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occurred immediately after receiving vaccine. Client seen and assessed by EMS an Vital signs are B/P 147/82, HR 80, O2 100%. Pt. voice that her anxiety level increased when receiving vaccine but now has decreased and symptoms decreased during observation. Second round of vitals B/P 139/82, HR 76, O2 99%. Client then verbalized that she is no longer having the sensation and asked to go home after 45 minutes of observation. Client denied the need to go to or be taken to the hospital and was cleared to go home by EMS. No physical reaction noted.
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| 66 | 2021-02-28 | feeling abnormal |
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come...
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tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
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| 66 | 2021-02-28 | sleep disorder |
veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and...
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veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and Hands; Tingling in Arm and Hands; some pain in the injection arm; muscles pain in the hands; a freezing cold sensation in her hands/her hands were frozen for 3-4 seconds; I would wake up with one hand completely numb; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included osteopenia and osteoporosis. She was shrinking, her height was about 5 feet 5 inches, she used to be 5 feet 7 inches. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D3 [CALCIUM CARBONATE;COLECALCIFEROL]), fish oil, vitamin e nos (OMEGA 3 [FISH OIL;VITAMIN E NOS]), vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). It was reported that on 09Jan2021, she received the first dose of the vaccine. She started to feel tingling and numbness in both hands the same day after the vaccine was administered. She states she also had some pain in the injection arm and that the numbness/tingling was off and on and traveled to her arms occasionally. She states, "I would wake up with one hand completely numb and it was worse the first 15 days but is getting better and is a little less than before." She states she would have a freezing cold sensation in her hands occasionally and she states her veins were more prominent and visible in her hands/arms around the 13th day after getting the vaccine. She further reported that when she received the vaccine, that same afternoon she started feeling a tingling sensation in the hands and arms, also a sensation of numbness like electrical accompanied with muscle pain. The Numbness and Tingling was on and off and well as the muscles pain in the hands. It was more noticeable 13-14 days later now. She would be sleeping at night and would wake up because of the sensation in the left hand or on the other right hand. The hands would wake her up. She provides an example of its like when your foot is asleep with the pins and needles, because you had your foot squished under for a while, like the foot falling asleep but in this case she wasn't doing anything and would have that feeling. Once or Twice when having breakfast she noticed that her hands were frozen for 3-4 seconds. After the 13 or 14 days, things are milder but now she still has the sensation, its not so often but milder. She also notices the veins in her hands are still swollen in the arms, its like the veins popped up. She is still having this. She is concerned since she is suppose to get second injection on 30Jan2021, she is concerned if she should still it. She is nervous. She clarifies that the first dose was on 09Jan2021 at 10 or 10:15 AM. On the same day is when she started noticing the Numbness and tingling in the Hands and arms on 09Jan2021. She noticed the Veins popping on 22Jan2021. Caller clarifies that she has no side effects in the legs, she was just providing that comment as an example. The outcome numbness in arms and hands, tingling in arm and hands, wake up with one hand completely numb, was recovering; pain in the injection arm, muscles pain in the hands, freezing cold sensation in her hands was unknown; and veins in her hands are still swollen in the arms was not recovered. The reporter assessed the events as non-serious.
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| 66 | 2021-03-01 | sleep disorder |
Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, c...
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Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, coughing, can't sleep for 8 hours, wake up at 3:30 am.
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| 66 | 2021-03-02 | anxiety |
1020 am Complaint of dizziness, increased heart rate and anxiety with sweaty palms. Patient stated t...
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1020 am Complaint of dizziness, increased heart rate and anxiety with sweaty palms. Patient stated that she did not take blood pressure medication this morning. BP 165/100, T 97.7, P 113, O2 98%. 1050 am T 97.9, P 67, O2 96%, BP 160/90. Patient states symptoms have subsided. Patient educated on taking blood pressure medication as directed by primary provider. Patient discharged from clinic.
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| 66 | 2021-03-02 | disorientation |
I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous...
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I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.
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| 66 | 2021-03-02 | impaired work ability |
pt states that about a week after getting the covid vax that she has developed severe pain from the ...
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pt states that about a week after getting the covid vax that she has developed severe pain from the upper part of her right hip down to her knee. Pt had an appt w/ Dr. on 2/25/2021 regarding her symptoms. She was prescribed tramadol HCL 50mg and methylprednisolone 4mg. Pt states she is going to have to contact her doctor since this medicine is not working and she is still in severe pain. She has been off from work for a week but had to go back and states it is very difficult since she cant hardly get up and down.
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| 66 | 2021-03-03 | disorientation |
DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THES...
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DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THESE SIDE EFFECTS CONTINUED ALONG WITH EXTREME FATIGUE, NO APPETITE, LOSS OF 6 LBS IN 6 DAYS, WEAKNESS. SYMPTOMS STILL PERSISTING ON DAY 8.
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| 66 | 2021-03-03 | feeling abnormal |
Cough; Chills; he came home and said he felt like crap, really bad, she said she did too; they are b...
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Cough; Chills; he came home and said he felt like crap, really bad, she said she did too; they are both so fatigued, so tired/exhausted; sore throat; major headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This is the first of two reports. A 66-year-old female patient (wife) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EN5318), via an unspecified route of administration on 27Jan2021 13:00 at single dose on the left upper arm for COVID-19 immunization, reported as "doesn't want to get the COVID". There were no medical history and concomitant medications. The reporter said that she and her husband got first dose of COVID vaccine last week (27Jan2021) and they both got sick, had a major headache in Jan2021, cough and chills both on 27Jan2021, and also she wanted to know if she and her husband can take the second dose, scheduled on 17Feb2021. Patient stated that major headache went in on a "Wednesday". Her husband and her did, and went through vaccination portal, to get an appointment, appointments were very trying, as they were to do all healthcare providers first, which is understandable, and then the vaccine. They were trying to make it available for teachers, as they are going back to school, in school learning in March, so all teachers were the next step and then also anyone over 65 was able to go on the portal with the state to get an appointment to go and get a vaccination. She and husband have a daughter who was a teacher, and she said to go on the portal to get the shot, and they said they didn't have access to it, so she went on the site, and they got it in on 27Jan2021. The headache occurred after the 27Jan2021. Patient stated that as soon as they got home, her husband works full time, she lost her job in October, and she was home and he said "how are you feeling", he went back to work, patient came home and said she felt alright except for her arm then she got a really bad headache. The husband came home and said he felt like crap, really bad, patient said she did too, she was the type of person she never ever gets sick and if he was sick she does not say she was sick. Patient had such a bad headache, she thought her brain was ready to jump out of her head. Headache subsided after two days. She has recovered completely from the headache. Cough started almost immediately (27Jan2021), but patient did not cough today, but did last night, it was usually a deep cough. Today she has not coughed at all. Chills started probably that evening (27Jan2021), when she came home, the shot was around 1PM and chills started in the evening, and went away probably, they had gone back and forth for around two days but they were gone, she has recovered completely. Patient wished to add that they were both so fatigued, so tired, almost like, both she and her husband were very active, when they were down for the count, really exhausted, after this whole vaccination experience, both of them have been exhausted, to the point of going to bed at 8, and they were not 8:00 going to bed people. she doesn't want to be a pain, as she knows people have legit concerns, Patient doesn't want to waste time, her main concern is the second vaccination, if she does not have to, or is suggested to not take it, or her husband, she doesn't want the second vaccination to cause more severe side effects. The patient further reported, that they both experienced major side effects: chills, headaches, sore throat, major cough, fatigue that was "just unbelievable, both of us are exhausted." Her second dose is scheduled on 17Feb2021 and his husband is scheduled on 20Feb2021. Patient was asking "if this was after the first dose, what's going to happen after the second dose?". Outcome of the events headache and chills was recovered in 2021 for cough was recovered on 02Feb2021 while for other events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105012 same reporter/drug, similar events, different patient
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| 66 | 2021-03-04 | amnesia |
Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Me...
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Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 66 | 2021-03-04 | anxiety |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 8:45 AM Ex...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 8:45 AM Expand AllCollapse All COVID VACCINE CLINIC 3/3/2021 Date: 3/3/2021 Subjective Patient is a 66 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm tingling. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH includes htn, takes 2.5 mg daily. She denies having issues with bp this am before coming. She ate breakfast earlier this am. No hx of diabetes. Hx of covid-19 infection in December. Not hospitalized. Still struggles with stamina since her illness. Evaluated in ED on 02/20/21 for chest pressure. Negative cardiac work up per pt. She is followed by her pcp. ALLERGY REVIEW OF SYSTEMS: Patient complains of malaise/fatigue (feels tired today.) and shortness of breath (chronic, not with exertion, tires easily. not changed from baseline.) Patient denies chills, fever, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, wheezing, vomiting, abdominal pain and diarrhea L arm numbness/tingling down arm. Negative focal neuro deficits. : Previous Reactions: none Objective Vitals Vitals: 03/03/21 1023 03/03/21 1045 03/03/21 1115 BP: (!) 156/84 (!) 152/89 (!) 147/80 Pulse: 61 76 Resp: 16 14 SpO2: 99% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: General: No visual field deficit. Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Normal range of motion. No muscular tenderness. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. Motor: Motor function is intact. Coordination: Coordination is intact. Gait: Gait is intact. Gait normal. Comments: +5/5 strength against resistance to upper and lower extremities. Psychiatric: Attention and Perception: Attention normal. Mood and Affect: Mood is anxious (slight anxious affect). Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Cognition and Memory: Cognition normal. Judgment: Judgment normal. Pt was taken to bathroom by LPN via wheelchair during her stay. She still felt weak upon her return. No dizziness/lightheadedness. She was given snacks and water x 2. Assessment/Plan Treatment included: water, snacks and reassurance/observation for about 40 minutes Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt improved with snacks and water. Discussed what to monitor and potential anxiety underlying as well. Pt to continue to monitor her bp at home and f/up with pcp if it continues to be elevated >140/90. Pt was able to ambulate out with ease and w/o dizziness/lightheadedness. Pt voiced appreciation of care today. APRN Electronically Signed 3/3/2021 11:21 AM
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| 66 | 2021-03-04 | mental impairment |
I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they w...
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I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they watched me and let me go after. I immediately begin to feel very tired and couldn't think, my neck began to hurt and feel stiff and started having chills and still having chills.
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| 66 | 2021-03-05 | anxiety | Pt experienced anxiety immediately following the vaccine shot and fainted |
| 66 | 2021-03-05 | impaired work ability |
After the second dose of the Covid-19 vaccine, I had the same mild allergy reactions as I had with t...
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After the second dose of the Covid-19 vaccine, I had the same mild allergy reactions as I had with the 1st dose: mild-moderate numbness of nose, throat - all subsided by taking Benadryl that afternoon/eve. However, for the next 36-48 hrs after this 2nd dose, I experienced mild-moderate "flu-like symptoms": exhaustion, total body aches, scratchy throat, only slightly elevated temperature. This reaction was strong enough to prevent me from going to work for 2 days, sleeping 12-13 hrs at a time.
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| 66 | 2021-03-05 | insomnia |
Low grade fever, headache, body ache, where I have arthritis pain was intensified and unbearable, s...
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Low grade fever, headache, body ache, where I have arthritis pain was intensified and unbearable, somewhat lightheaded, vision slightly blurred-felt like I was in a tunnel, very tired and couldn?t sleep . I had control of my arthritis and as of today (3/6/21) 16 days after shot it is mostly painful, 7 out of 10. Mild lingering headache, and have trouble sleeping.
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| 66 | 2021-03-06 | insomnia |
About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting...
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About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting very badly in both legs and had a very stiff neck and a headache. I have arthritis all over my body. I am not sure if the vaccine brought on the pain or if my arthritis caused the pain. But, I have not had that much pain with my arthritis before the 2nd dose vaccine. I was in so much pain I could not find a comfortable position in my bed to be able to go to sleep. I was awake until dawn. Finally, the pain became less and I was able to fall asleep and sleep about three hours. Today, 3-8-21, I feel fatigued and still have minor pain in my ankles. Like I said I have never been in so much pain before. The 1st dose vaccine only gave me a very sore arm.
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| 66 | 2021-03-07 | agitation |
24 hours after the injection I started to flush on my face neck and ears. I itched all over especial...
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24 hours after the injection I started to flush on my face neck and ears. I itched all over especially my eyes and throat. I was very agitated and shaking. I took an allergy Med at 2 pm and again at 7pm. The 2 Nd dose calmed me enough to get to sleep around 11pm. I was very close to going to the ER. In the morning I had a stomach ache like I have experienced before with and allergic reaction. Cramping pain , it lasted all day there was no nausea. The 3 day a headache that seemed appropriate for the vaccine.
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| 66 | 2021-03-07 | disorientation |
Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain w...
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Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
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| 66 | 2021-03-07 | disturbance in attention |
I experienced the loss of a sense of taste and exhaustion one day after the shot and could not have ...
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I experienced the loss of a sense of taste and exhaustion one day after the shot and could not have the strength and attention pan to continue cooking. I have also been suffering from Lingering episodes of sudden physical faintness and mental stupor. This is most noticeable after engaging in my normal walks of one mile or less.
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| 66 | 2021-03-08 | sleep disorder |
12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from h...
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12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from head to toe, that was not effected by motrin. fever and severe muscle pain had me rolling in bed with pain. Also simultaneously, My left arm, site of injection swelled twice its size, red, and had trouble moving it. Also noticed a swelling in left arm pit, which has improved but a slight swelling is still present . after exactly 48 hours , fever left, muscle pain stopped. Fatigue continued for 5 days. I have had many vaccines in my life, including flu vaccine every year and never experienced such severe symptoms. When I reported this to my PCP, he said it just means your immune system is doing its job no worries
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| 66 | 2021-03-09 | feeling abnormal |
Muscle aches, fuzzy headed, headache, chills and lots of pain in my knee replacement done 9/21/2020...
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Muscle aches, fuzzy headed, headache, chills and lots of pain in my knee replacement done 9/21/2020. That knee pain abated after a few hours.
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| 66 | 2021-03-09 | feeling abnormal |
My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, ...
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My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, I had to keep it my side. I also had a headache. 9 days after the injection I had extreme fatigue and wasn't myself. During the night My right arm/shoulder started throbbing and hurting again. I was cold and lightheaded. When I woke up I was fine!
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| 66 | 2021-03-10 | amnesia |
Caller says the the pt started having really bad headache the day after taking the vax that lasted a...
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Caller says the the pt started having really bad headache the day after taking the vax that lasted about a week and half. She had 4 hours of amnesia. Pts husband took her to Hospital ER where she had a brain scan and was diagnosed w/ TGA and then admitted.
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| 66 | 2021-03-13 | insomnia |
5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I...
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5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I wasn't interested in eating, the pressure/discomfort feeling was increasing and I was uncomfortable all over and unable to get to sleep. Around 2 or 3 am, I had an episode of violent vomiting, which did not serve to make me feel any better. From that point on, for the next 24 hours, I continued to feel sick, extremely tired, and ached all over. I couldn't get comfortable, didn't feel like eating or even drinking, and had no energy, even to not being able to sit up and watch TV. As the 7th day continued, I threw up mid-day, was able to sip my way through 2 glasses (water, tea), and eat a few crackers. I felt very dizzy when I walked. I checked my temperature twice and didn't seem to be running a fever, which surprised me. I didn't take any pain relievers, as I felt I would just throw them up. By evening, however, I was able to take 2 ibuprofen, take a hot shower, and slept pretty well that night. By the 8th day, the aches were pretty much gone and I was able to eat soft foods and get rehydrated. I felt a little weak, still tired, and wobbly, but was clearly over the worst of it. By the 9th day, I was back to normal.
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| 66 | 2021-03-13 | sleep disorder |
Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs,...
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Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs, chills. Took Tylenol. Woke up around 7am. Not feeling any better. The tip of my tongue felt as if it was dipped in hot sauce. Slept most of the day. Chills came back. Took Tylenol. Today (3/14), better, but still weak. Under my tongue is very sore.
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| 66 | 2021-03-15 | disturbance in attention, feeling abnormal |
I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm...
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I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm. After the second dose on Febrary 16, 2021, I expereinced the following in the following order. I did not feel better/normal until March 12. 101 fever for 24 hours, headache for days, chills, slight nausea, pain and aches all over and in joint areas, pain under shot arm in gland areas, black eyes and eye aches, divertiulitus event, brain fog - not being able to have sharp recall, and hives last 7 days.
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| 66 | 2021-03-15 | feeling abnormal | Fogginess in my head going on 13 days now |
| 66 | 2021-03-16 | impaired work ability |
Injection was apparently given in the bicep area as opposed to the deltoid. Patient complained of s...
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Injection was apparently given in the bicep area as opposed to the deltoid. Patient complained of soreness and swelling thereafter (which is improving by the time she comes in for her second vaccination,) but she still has some limitations in range of motion which inhibits her work as a sign language interpreter. She has had no distal paresthesias or weakness, just soreness surrounding the site which she indicates to be the left inferolateral bicep area where there is a minute reddish (presumed) puncture site and underlying induration.
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| 66 | 2021-03-16 | restlessness |
Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When o...
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Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When observation nurse was checking on patient to allow the to leave, resident complained of light headed. Patient brought to triage for evaluation. Patient reported they had a Vasovagal response 6 years ago. Vital signs were taken, all within normal limits. Ice pack was applied to back of neck, as patient felt flushed and juice was given. Patient said she did not eat breakfast when asked. Patient was observed being very restless and rubbing/scratching her arms, scalp and upper back. Rash was noted on upper back left side, NO hives. Benedryl 50 mg IM was given. Called patients friend, patient did not want emergency contact called for pickup. Patient's friend was willing to come and pick her up. Patient observed with diminished restlessness and itching. Patient reported a "tightness" in her neck muscles, almost like she had swollen glands. Patient was able to talk well, no c/o of SOB or difficulty breathing or itchiness of her throat. Patients friends arrived, informed of the incident. Patient was sleepy, rash was gone, patient denied any more itching, patient appeared more peaceful. Advised if she had any worsening symptoms or signs of a severe allergic reaction to call 911. Patient stayed in total for 90 minutes. Patient was assisted by nurse to her friends car.
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| 66 | 2021-03-17 | sleep disorder |
I awoke during the night I received my vaccine with some mild itching of my extremities, but no rash...
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I awoke during the night I received my vaccine with some mild itching of my extremities, but no rashes. This disappeared by the morning. On 3/11/21, I discovered an enlarged lymph node near my left collar bone. As of today, 3/18/21, the lymph node is still palpable and hasn't changed.
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| 66 | 2021-03-18 | feeling abnormal |
Chronic diarrhea since about a week after the first vaccine. It's been two months now, and no relief...
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Chronic diarrhea since about a week after the first vaccine. It's been two months now, and no relief. I just saw a NP this week about it. Also, one week after the 2nd Pfizer injection, I had a headache all day (very unusual for me) and felt strange, not well, weird, had to go to bed at 6:30 pm because I just felt flu like symptoms. I slept all night and was fine the next day, accept for the diarrhea.
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| 66 | 2021-03-18 | insomnia |
Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by ri...
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Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by right hand/arm. Pain spread to left side of head, neck, upper, then lower back. Extreme pain in lower back. General feeling of un-wellness, and wanting to die. Insomnia, and extreme tiredness. Thursday pm pain in left arm subsided, still very tired, severe pain in low back, slept better. Friday, as I write, no more pain in left arm, paralysis subsided, as well as head, neck pain. Low back pain still exists. Did not seek medical help. Took Hydrocodone and Tylenol, iced areas of pain. Not looking forward to next shot. Will contact my allergy doctor regarding if I should get second shot.
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| 66 | 2021-03-19 | feeling abnormal |
I felt dizzy and lightheaded right after the shot. That night my arm was hurting me very badly. I st...
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I felt dizzy and lightheaded right after the shot. That night my arm was hurting me very badly. I started to feel feverish and extremely fatigued the next day. I also felt achy. I have intermittent very mild headaches and just feel lousy.
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| 66 | 2021-03-19 | sleep disorder |
After second vaccine, felt severe injection site pain/pain moving arm. Lasted for 3-4 days then got...
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After second vaccine, felt severe injection site pain/pain moving arm. Lasted for 3-4 days then got better. Then, about 4 days after this, pain increased. Couldn't sleep on that side, interfered with sleep, painful to move. This pain is still there and it's been 5 weeks. VERY slowly getting better. I recently started using CBD ointment and husband massaging upper arm. Reported to my doctor on Feb. 22 and he said it should get better in 7-10 days. (I'm unable to take steroids or ibuprofen due to medical reasons.) I also had a one-time milky discharge from nipple in breast after this second injection on side of injection. GYN Dr. said not to worry /return unless it happened again. It didn't. But I can't find anything about this type of long-lasting arm pain I'm having.
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| 66 | 2021-03-20 | confusional state | N/v, confusion, headache, chills, weakness |
| 66 | 2021-03-20 | sleep disorder |
Headache-muscle aches all over- fever of 102 Took Tylenol overnight was unable to sleep because pain...
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Headache-muscle aches all over- fever of 102 Took Tylenol overnight was unable to sleep because pain from symptoms. Still going and the time is 9;30AM Sunday March 21st
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| 66 | 2021-03-21 | confusional state |
Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty form...
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Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty forming words. Words were very garbelled. Extremes sweatness. chills.
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| 66 | 2021-03-23 | loss of personal independence in daily activities, sleep disorder |
Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple p...
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Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple parts of my body: wrists; left groin and leg; neck/shoulders; lower back and had a headache. All of these areas were thrubbing and interrupted sleep. Also was very weak. Was difficult to get out of bed or a chair and to walk. Also had loss of appetite. At no time, did I have a temperature.(Note: I play tennis so was very active early in the week). The course of the symptoms has lasted 96hours but now seems to be subsiding. After 48 hours of inability to do any normal life activities, I contacted my physician who prescribed a cordtisone shot and anti-inflamatory medication, which I've taken for 2 days.
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| 66 | 2021-03-24 | excessive sleepiness, depressed mood |
Strange side effect started 5:30 pm 3/13 date of second injection. Felt extremely sad, depressed. ...
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Strange side effect started 5:30 pm 3/13 date of second injection. Felt extremely sad, depressed. Felt like crying but couldn't cry. Didn't know why I felt sad. Otherwise I felt great. Next day extremely tired, slept all day, couldn't move off the couch, had 100 degree fever, had light breakfast in am, light salad at 9:00 pm. Again, extremely sad in the morning, but as other symptoms took over sadness went away. The next day felt fine--no sadness, no symptoms. (Expected other side effects, but didn't expect sadness. I'm finding on facebook several other people felt sadness too, didn't know why. Other symptoms were expected.) No symptoms since.
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| 66 | 2021-03-24 | loss of personal independence in daily activities, sleep disorder |
Patient reported that she believes her vaccine was given too high in the arm. This was reported week...
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Patient reported that she believes her vaccine was given too high in the arm. This was reported weeks after receiving her second dose of the vaccine. She has experienced a lot more pain than the first dose, and was unable to do daily activities such as raising her arms above her head and sleeping on her side. She has been in contact with her doctor regarding the incident. The pain has gotten better in the last week, but some pain is still present.
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| 66 | 2021-03-24 | nervousness |
9:50 pt c/o mild pressure in middle of forehead and nervousness. Elevated legs and provided water. P...
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9:50 pt c/o mild pressure in middle of forehead and nervousness. Elevated legs and provided water. Pt took her own Tylenol at 10am. Reassessed at 10:15 due to pt coughing and constantly clearing throat, sensation that something was in her throat. NP administered 25 mg Benadryl PO at 10:20. Pt stated head issue resolved after Tylenol @ 10:45. 10:50 symptoms resolved states feels better, denied headache, and throat discomfort. She was able to drink water and eat candy (patient brought the candy). Discharged at 11:03.
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| 66 | 2021-03-25 | excessive sleepiness |
I started fever 100.8 the next morning after the second vaccine, then climbed up to 101.2 in the af...
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I started fever 100.8 the next morning after the second vaccine, then climbed up to 101.2 in the afternoon. I also had attacking pain here and there, in joint, or muscles. It moves around every few seconds. I drank a lot of water and slept a lot. All symptom were gone by the evening. And I felt my normal self. But I started feeling a lump in the neck yesterday, feels like swollen lymph node. When i touch it or swallow food I feel the pain. Not sure if it is vaccine related. I feel it is. So I decided to report. Since it is Friday night now I couldn't check with my doctor till at least Monday.
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| 66 | 2021-03-25 | sleep disorder |
Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3...
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Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3/16 Big Toe throbbing woke me up. Throbbing stopped in big toe and then moved to right wrist, then stopped at wrist and went to left leg. Throughout the next 24 hours their would be sharp pains in right ankle. Left arm at injection sight very painful. Pains would occur in different body parts next 24 hours. Extreme tiredness to the point of ongoing sleep well passed the 6 hours of regular sleep for me. It took 4 days for me to start to feel I was returning to normal function, the fifth day I felt normal. I thought this was a long time to recover from shot in comparison to what I did hear.
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| 66 | 2021-03-26 | sleep disorder |
Two hours post injection, experienced excessive, productive clearing of throat with a feeling of con...
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Two hours post injection, experienced excessive, productive clearing of throat with a feeling of congestion in chest which is still present. One week post injection could not sleep due to onset of frequent and bothersome cardiac palpitations with chest tightness which is still present at two weeks post vaccination.
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| 66 | 2021-03-27 | feeling abnormal |
Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began ...
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Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began soon after, and then vomiting. Both projectile (I know, eww). I experienced this every 30-60 minutes for about 7 hours. Then the nausea subsided, and the episodes of diarrhea began to happen at longer intervals. I also experienced cold sweats and the next day my body temperature was reading low (96.4 at one point). My brain fog and weakness were probably the result of dehydration.
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| 66 | 2021-03-28 | disturbance in attention |
1st dizzy distant feelings, hard to walk or think. later sleepy, legs aches body aches, severe head...
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1st dizzy distant feelings, hard to walk or think. later sleepy, legs aches body aches, severe headache ears teeth ache, chills muscle spasms, sensitivity to lite, smells, nausea, vomiting, diarrhea extreme fatigue dizziness and inability to think correctly. worst part lasted for 36 hrs, Felt human after 5 days
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| 66 | 2021-03-28 | feeling abnormal |
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous...
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feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021. Follow-up attempts are completed. No further information is expected.
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| 66 | 2021-03-28 | feeling abnormal |
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination;...
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peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-28 | impaired work ability |
No issue with the first shot of 3/3/2021, the second shot of 3/24/2021 was a different story. Headac...
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No issue with the first shot of 3/3/2021, the second shot of 3/24/2021 was a different story. Headache, even my hair hurt. Joint pain, backache, eyes sensitive to light, nauseated spent most o the night throwing up. Dizzy & weak. Arm hurt & swollen as well. It is now 5 days later and I'm still not 100%. I missed 2 days of work and rested as much as possible over the weekend.
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| 66 | 2021-03-28 | irritability, agitation, poor quality sleep |
3/21 felt fine went for a 3 mile walk. 3/22 feeling fatigued, by 6PM felt irritable. 3/23 very agita...
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3/21 felt fine went for a 3 mile walk. 3/22 feeling fatigued, by 6PM felt irritable. 3/23 very agitated, unfocused, irritable, mood swings, couldn't sit still wanted to scream, but didn't. 3/24 feeling same way, sleep is restless. 3/25 same, 3/26 same, 3/27 all feeling are lessening. 3/28 feeling much better. 3/29 feeling normal again!! All symptoms gone.
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| 66 | 2021-03-30 | excessive sleepiness |
Extreme fatigue and muscle and body aches; slightly elevated body temp, loss of appetite, slept 15-1...
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Extreme fatigue and muscle and body aches; slightly elevated body temp, loss of appetite, slept 15-18 hours
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| 66 | 2021-03-30 | insomnia |
she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at a...
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she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at all; she had achiness; she knewshe had a high fever; Sweating; unbelievable fatigue/she was really tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in the right arm, on 04Mar2021 16:30 (at the age of 66 years old) at a single dose for covid-19 immunisation. This was administered as a pharmacy/drug store. Medical history included asthma for a very long time and overweight. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular route in the right arm on 30Jan2021 (at the age of 66 years old) at a single dose for covid-19 immunization. She did not have any problems with the first dose. The patient had no additional vaccines administered on same date of the Pfizer vaccine. There were no prior vaccinations within four weeks. The patient reported she was really tired after receiving her second COVID-19 Vaccine on 04Mar2021, saying she slept unbelievably good the night of 04Mar2021. On 05Mar2021, the patient experienced she had instantly come down with unbelievable fatigue, she wanted to sleep a lot, she had no energy at all (if she tried to do something, she would have to lay down afterwards), she had achiness, she knew she had a high fever, even though she did not check her temperature, she knew her fever was high because she was sweating but it was nothing she was worried about. She stated she was concerned about the unbelievable fatigue she was experiencing. Her tiredness had improved some, and her achiness resolved about the second day (unspecified date in Mar2021). She stated her fever went away in two days (unspecified date in Mar2021). Reported the pharmacist told her to take TYLENOL after the second COVID-19 Vaccine. She bought a bottle of TYLENOL while she was at the drug store, but she decided not to use the TYLENOL for the symptoms. Reported she didn't take her PROLIA injection in Jan2021 because she didn't want it to interfere with her upcoming COVID-19 Vaccine. She said she self-administered her PROLIA injections, and hadn't restarted it at this time. All the events did not require a visit to emergency room or physician office. Outcome of the events fatigue, she wanted to sleep a lot, she had no energy at all was recovering. Outcome of the events achiness, fever and sweating was recovered on unspecified date in Mar2021. Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296202 same reporter, drug and events, different patient
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| 66 | 2021-03-30 | irritability |
having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ri...
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having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ridiculous, and the fatigue knocked her off her feet; feeling jittery and irritable; feeling jittery and irritable; This is a spontaneous report from a contactable consumer. This 66-Year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (Pfizer-Biontech COVID 19 vaccine, Lot number EN6200) at single dose for COVID-19 immunisation on 26-FEB-2021 at 11:30. Relevant history was unknown. The patient previously received Pfizer-Biontech COVID 19 vaccine on 05Feb2021 for COVID-19 immunisation. Past drug included mild blood pressure medication. Relevant concomitant drug was unknown. The patient has fatigue, she kept getting choked when drinking water, feeling jittery and irritable since 28Feb2021. She said the fatigue was ridiculous, and the fatigue knocked her off her feet. The patient asked if there was something she could do for the fatigue she was experiencing. This reaction was really not good. She was having problems swallowing. She said the swallowing problem started at the same time as the fatigue on Sunday, 28Feb2021. No treatment was received for the events. The outcome of event having problems swallowing was not resolved. The outcome of other events was unknown.
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| 66 | 2021-03-30 | mental status changes, loss of personal independence in daily activities |
Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed ...
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Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed for approximately 2 minutes. Code called and patient sent to ER via 911 No history of Seizures she has ongoing seizures. there is a significant decline in her mental status. She is not speaking. She has to be fed. She is not walking.. She is scheduled to see a neurologist in June 2021.
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| 66 | 2021-03-31 | disturbance in attention, impaired work ability |
My shoulder joints and back of neck felt sore about 30 mins after the vaccine. About 2 hours after t...
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My shoulder joints and back of neck felt sore about 30 mins after the vaccine. About 2 hours after the vaccine I felt exhausted. I tried to ignore it but could not concentrate on my work and ended up going to bed and falling asleep for 3 hours. Got up briefly and then slept through the night. The next day I was completely exhausted and couldn't work so I gave up and went to bed. I had mild chills but no fever (67.3). Basically stayed in bed all day. The next day I woke up feeling completely fine, except for a sore arm at the injection site. I had no treatment. I still have days when I feel exhausted. Since most get these symptoms after the 2nd shot I'm a bit concerned that my 2nd may be worse.
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| 66 | 2021-03-31 | excessive sleepiness |
Headache for 3 days (3/12-3/14) & muscle aches & lower back pain 3/14-3/20 & major fatigue 3/13-3/20...
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Headache for 3 days (3/12-3/14) & muscle aches & lower back pain 3/14-3/20 & major fatigue 3/13-3/20. I took Extra strength Tylenol for the headache. I took Tylenol during the day for muscle aches & lower back; & Tizanidine muscle relaxer each night. By 3/18 I was exhausted & slept from 6:30 pm 3/18 to 9:45pm on 3/19. Was awake 1.5 hrs & was back to bed sleeping until 8:45am on 3/20/21.
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| 66 | 2021-04-01 | anxiety |
After getting the second Pfizer vaccine, I experienced shortness of breath. Riding my bike the shor...
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After getting the second Pfizer vaccine, I experienced shortness of breath. Riding my bike the shortness of breath was noticeable as I had to walk up hills I normally ride up and I was winded. I went for a complete nuclear stress test with a known cardiologist and got a completely normal heart reading. My heart is healthy, but I am experiencing shortness of breath all the time, more so when I exercise. My cardiologist said that even though there is only anecdotal evidence, other people have complained about symptoms lasting after the second shot and he recommended that I see how I feel in a month from now, although as an active person, I feel anxious about my symptoms.
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| 66 | 2021-04-01 | fear, anxiety |
short of breath; fear and anxiety or from the vaccine; fever blisters; fear and anxiety or from the ...
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short of breath; fear and anxiety or from the vaccine; fever blisters; fear and anxiety or from the vaccine; like bells palsy; numbness of the right side of her face from her jaw to her ear and up to her right eye; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9267), via an unspecified route of administration, on 26Feb2021 (received at the age of 66-years-old), at a single dose for COVID-19 immunization. Medical history included cold sores, 2 knee surgeries, and ADD (Attention deficit hyperactivity disorder) from an unspecified date and ongoing (diagnosed at 30-years-old). Concomitant medications included methylphenidate hydrochloride (RITALIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and other regular medication. The patient received first dose of Pfizer BioNTech vaccine and developed numbness of the right side of her face from her jaw to her ear and up to her right eye on 26Feb2021. It felt like she had received a lidocaine injection. Her doctor said this can happen with RNA vaccines, affect the 7th cranial nerve and develop Bell's Palsy. She was prescribed Valacyclovir 1mg and has taken it for 3 days. She wants to know what the other Bell's Palsy cases were like. She wants to know what their treatments were. Her doctor said it was okay to receive her second dose at 8am on 20Mar2021 but she wants to do her due diligence and see if there is a case report or study on these patients that developed this side effect. The patient further explained that she had her first dose on 26Feb2021 and was she was there for the 15 minutes for observation. On her way home, the right side of her mouth and the right side of her nostril were numb like Novocaine that you get at the dentist. She said that the numbness traveled up the right side of her jaw to her ear and then over to her right eye. When she got home, she told her daughter and she said that she thought it was because she volunteered all day and was worn out and anxious (26Feb2021). She said that she slammed water and ate crackers and after about a 1.5 hours she started to feel better. She said that she then she called her physician and the doctor told her that it was flaring the nerve root like bells palsy and that it is a RNA Virus. She said that she was placed on some medication for it, but was wondering if she should get the second dose of the vaccine. She said that the doctor asked her if she had previously had cold sores and she said yes. The caller said that her doctor said that it is exactly what that is. The patient stated that she was also short of breath on an unspecified date, but thought it was from fear and anxiousness. She does not know if it was from fear and anxiety or from the vaccine. She said that the doctor told her to take the medication 3 days before and 3 days after her second dose. She clarified that the doctor put her on Valacyclovir HCl 1Gm tablets 1 a day. She said that she broke out with fever blisters on 02Mar2021. She really did not think anything of it until speaking with friends in the medical field and they told her to follow up with this. She added that the fever blisters are healing and only a tiny bit left. It is at the scab and end of healing. Outcome of numbness of the right side of her face from her jaw to her ear and up to her right eye was recovered on 26Feb2021. Outcome of fever blisters was recovering. Outcome of other events was unknown.
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| 66 | 2021-04-03 | feeling abnormal |
fogginess; tiredness; dizzy feeling. lasted 24 hours.; chills at night; cloudy minded. started appro...
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fogginess; tiredness; dizzy feeling. lasted 24 hours.; chills at night; cloudy minded. started approximately 2 hours after shot; sore arm for 24 hours as well; numbness in top of hand and thumb and pointer finger; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, on Arm Left on 22Jan2021 at 12:15 as a single dose for COVID-19 immunization. Medical history included coronary artery disease, cough, back issues, arthritis and multiple allergies (from an unknown date and unknown if ongoing). Patient had allergies to medications, food, or other products. Concomitant medications included levothyroxine (Levothyroxine), clopidogrel bisulfate (Plavix), dexlansoprazole (Dexilant), metoclopramide hydrochloride (Metoperon) and pravastatin (Pravastatin). All medications were received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Jan2021, immediately after vaccine, warmth radiating down left arm followed by numbness in top of hand and thumb and pointer finger. Lasted several hours. Approximately 2 hours after shot), the patient experienced chills at night and cloudy minded. At 14:00 patient had fogginess, tiredness and dizzy feeling. Lasted 24 hours. Patient had sore arm for 24 hours as well. No treatment was provided for events. Outcome of the events was reported as recovering.
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| 66 | 2021-04-03 | insomnia |
Two hours after my first shot I noticed a zinc taste in my mouth and moderately bothersome tinnitus....
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Two hours after my first shot I noticed a zinc taste in my mouth and moderately bothersome tinnitus. Both lasted the rest of the day, about 12 hours, and gone the next day. About five days after my second shot the tinnitus returned. Now, around 10 days later, the tinnitus has progressed to the point where it is bothering me all day and interfering with already difficult sleep.
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| 66 | 2021-04-04 | anxiety |
Per EMS Report: 66 y/o female complained of anxiety and bad taste in her mouth post vaccination. M...
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Per EMS Report: 66 y/o female complained of anxiety and bad taste in her mouth post vaccination. Monitored by onsite EMS for 40 minutes. Symptoms worsened, complained of tongue swelling and difficulty breathing. Benadryl 50 mg. administered intravenously. Client refused further medication intervention. Transported via Fire Rescue to Medical Center at 12:03pm.
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| 66 | 2021-04-05 | disturbance in attention |
Tuesday March 30th 2021 Received Pfizer Dose #2 at 12:25pm resulting in injection site pain. By 3:30...
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Tuesday March 30th 2021 Received Pfizer Dose #2 at 12:25pm resulting in injection site pain. By 3:30pm adverse symptoms began: Dizziness, lightheadedness, pain from injection site gradually radiating down left arm and into left leg, later to right side and ultimately all over body. It felt like muscle aching all over my body (run over by a truck feeling as people describe.) Bedridden ? Severe fatigue and lethargy ? Dizziness ? Lightheadedness ? Muscle aching all over body ? Chills ? Sweats Wednesday March 31st 2021 Bedridden ? All the above plus pounding throbbing migraine headache ( Contacted Dr. and although I have high BP was allowed to take Aleve, and 1 pill got rid of the headache within hours thankfully) Thursday April 1st 2021 (Bedridden and sat in chair) ? All the above from Tuesday plus severe abdominal pain doubling over with vomiting four times Friday April 2nd 2021 (feeling mildly better, able to stand to take a shower. Sat in chair most of day) ? Dizziness and light headedness persist ? Moderate fatigue and lethargy (reducing) ? Moderate body aching ? No chills and sweats ? Nerve tingling similar to when hitting funny bone in elbow but in hands and arms ? Poor cognitive abilities Saturday April 3rd 2021 (Contacted dr regarding long duration of these persisting adverse symptoms and told to overly hydrate, a prescription was called in for anti-nausea medication to take if needed. Not needed, not taken, not picked up. This may last up to two weeks!) ? Same symptoms as Friday Sunday April 4rd 2021 (Feeling better in the morning, able to bake a cake, but afterwards bedridden again for the rest of the day.) ? Severe fatigue and lethargy ? Dizziness ? Lightheadedness ? Moderate body aching ? Poor cognitive abilities in thinking, memory etc. ? Nerve tingling similar to when hitting funny bone in elbow but in hands and arms ? Minimal chills and sweats Monday April 5rd 2021 (Cancelled all plans and sat by computer.) ? Same as Sunday but with severe chills and sweats and a bonus of 3 bouts of diarrhea Tuesday April 6rd 2021 In bed all morning and sat during afternoon. (Phoned to notify both Pharmacy where I received Pfizer #1 and the Pfizer #2 and doctor?s office of persisting adverse side effects) Contacted VAERS which timed out my responses twice on line and left a message on their phone recording to contact me. Sending this by fax to Dr.'s office. ? As of 4pm same symptomatology as Sunday
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| 66 | 2021-04-06 | excessive sleepiness |
Started with headache, aches in joints and muscles, stomach pain. Slept most of the day Wednesday a...
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Started with headache, aches in joints and muscles, stomach pain. Slept most of the day Wednesday and by Wednesday evening was feeling a little better. No appetite.
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| 66 | 2021-04-07 | depressed mood |
anterior uveitis / can't see well enough; it was getting better, but it was not happy; This is a spo...
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anterior uveitis / can't see well enough; it was getting better, but it was not happy; This is a spontaneous report from a contactable physician reported for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, deltoid right on 10Mar2021 (batch/lot number EN6208 and expiry date not reported) at 66 years of age as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included some over the counter B12 (unspecified). The patient informed that she developed an anterior uveitis which started 2 days post her COVID injection (12Mar2021). The patient informed that she will be reporting online but she can't see well enough (Mar2021) to report online. The patient informed that "it was getting better, but it was not happy". The patient informed that in response to the vaccine she was on Prednisolone 1 percent ophthalmic eye drops. The patient confirmed that she was taking Prednisolone as a treatment (for the events) and was still on it. The outcome of the event anterior uveitis was not recovered, while unknown for the other event. The physician informed that causality was "yes".; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event iridocyclitis cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 66 | 2021-04-07 | irritability |
Fever 99.8° at onset, low-grade continues 98.9°. Muscle aches, injection site and throughout body....
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Fever 99.8° at onset, low-grade continues 98.9°. Muscle aches, injection site and throughout body. Fatigue and irritability. Taking Tylenol (listed above) and resting lots.
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| 66 | 2021-04-08 | confusional state |
Diarrhea, chills, swollen lymphoma node, chills, body aches fever, eyeballs hurt when moving them, t...
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Diarrhea, chills, swollen lymphoma node, chills, body aches fever, eyeballs hurt when moving them, tiredness, muscle and joint pain, sweating, weakness and confusion.
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| 66 | 2021-04-11 | sleep disorder |
Thursday and a couple hours later I had bad pain and took Tylenol, the evening I was hurting I could...
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Thursday and a couple hours later I had bad pain and took Tylenol, the evening I was hurting I couldn't lift my arm because the pain was at a 15 on scale of 1-10. I couldn't even get out of my clothes it hurt/ache so bad, I took my pain meds at bedtime and 4-5 hours later the pain woke me up and I took another series of OTC pain pills. Saturday I had nausea, a massive headache, I didn't have an appetite,
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| 66 | 2021-04-12 | fear |
I have sensorineural hearing loss in my left ear. Following the vaccine, the next day I had an incr...
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I have sensorineural hearing loss in my left ear. Following the vaccine, the next day I had an increase in tinnitus and a decrease in speech recognition. i also had fever, chills and fatigue. My arm was very sore and bright red. It was very hot to the touch.
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| 66 | 2021-04-12 | feeling abnormal |
Allergic Reaction post-vaccination, including shaking, paleness, lightheadedness, dizziness. More sy...
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Allergic Reaction post-vaccination, including shaking, paleness, lightheadedness, dizziness. More symptoms, such as nausea, vertigo, facial numbness, "buzzing" feeling, chills/sweats, brain fog from second day to day 14, coming in waves.
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| 66 | 2021-04-12 | panic attack | "feels like a panic attack with elevated HR". Evaluated by EMS-Cleared |
| 66 | 2021-04-12 | restlessness, sleep disorder |
at about 4 hours after vaccine I thought I was having a stroke. The right side of my face went numb ...
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at about 4 hours after vaccine I thought I was having a stroke. The right side of my face went numb and felt like it was drooping, my right arm went numb, my right leg and foot went numb. But I could still talk and make a smile face so I did not go to ER. Gradually both of my legs became very weak and then my hands became very weak. This lasted for over a week/ten days. By the first night I couldn't sleep because my brain could not seem to get into a deep sleep pattern, had body aches and sore arm but not dreadful, and by the next day had a fever which maxed at 101 degrees ( my normal is 97.2-97.4). Had a low grade fever for 10 days! Also by the 2nd day I had swollen glands in my right neck and armpit, and pain from my right elbow to my neck. My usual level of unstable balance was MUCH worse for at least a week and my usual tinnitus was MUCH louder than usual for about 10 days! Night 3 I had a very bad episode of something like restless leg which also extended not just in my legs but also into my head! Very bizarre! By day 4 I was having episodes of near fainting, often. This lasted for about another week. All in all it was a dreadful experience, which I believe was related to issues with my already compromised nervous system due to the Parkinson's/MSA. I will NEVER have another one fetes vaccines or booster shots if those become available. I am quite frightened that the next vaccine could result in me actually having a stroke or other serious consequence.
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| 66 | 2021-04-14 | feeling abnormal |
Received 2nd Covid vaccine yesterday at 2 pm; Signs/symptoms started around 11 pm last night; Was f...
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Received 2nd Covid vaccine yesterday at 2 pm; Signs/symptoms started around 11 pm last night; Was feeling fine then suddenly a "rush" over her body; Fluttering got worse in her chest, hx of chronic fluttering; Chest tightness, Shortness of breath, her HR and BP went up-- blood pressure was 140/95, pulse was 92, nauseated and felt like she achy all over and like she was going to just pass out; Lasted for a little while last night; Today doesn't feel like she will pass out but still doesn't feel well; Current signs/symptoms: HR 99; Fluttering in her chest that she feels is worse than her normal; Chest pain rated at 6/10- not radiating; Shortness of breath that she feels is a little worse than her normal; Soreness all over her body; Nauseated; Chills, slight headache; BP is normal today she states; RN referred patient to ER today due to s/s.
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| 66 | 2021-04-16 | anxiety |
Pt showed signs of anxiety including hyperventilation. EMS evaluated and watched her 40 min. Vital...
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Pt showed signs of anxiety including hyperventilation. EMS evaluated and watched her 40 min. Vital signs remained stable 122/88, 79, 98%. However, her end total CO2 would drop to 19-22 until paramedics calmed her down and she was free to go home. Patient gave us an extensive list of over 50 allergens and her reactions, including abx, pain meds, methadone, fire retardant, Tylenol and Advil. However, she states that she refuses to carry an epipen even though she claims to have experienced anaphylaxis over 20 times. Pt also refused transport for further observation.
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| 66 | 2021-04-16 | feeling abnormal |
Flushing, flushed red hot face, swollen red hot ears, fever, severe headache, gastrointestinal symp...
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Flushing, flushed red hot face, swollen red hot ears, fever, severe headache, gastrointestinal symptoms, brain fog, backache
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| 66 | 2021-04-17 | crying, panic attack, panic reaction |
Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurt...
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Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Unable to lift arm, pain makes her catch her breath/ Difficult to take a deep breath; Thought she was having a heart or panic attack; Stress, heart rate, panic; soreness from the shot; Stress, heart rate, panic; Stress, heart rate, panic; Stress, heart rate, panic; Tingling in hands and down the arm; crying; This is a spontaneous report received from contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 66-years-old on 22Mar2021 13:57 (Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included topiramate taken for migraine from 15Mar2021 and ongoing. The patient had her shot last Monday afternoon and had some soreness from the shot on Mar2021. On Tuesday, 23Mar2021, it began getting sore back behind her shoulder blade; it has gotten progressively worse, and now she can barely lift her arm. She does not know if it's a muscle or has to do with the vaccine, or if she pulled a muscle although she has not done anything. It's difficult to take a deep breath, she can't lift her arm, it is sore. It hurts down into her chest and around her breast; also, hurts around on her back where her shoulder blade is. She has tried heat compress, cold compress, and massage the area. It seems like the pain will ease up but then it starts again. She becomes stressed about it and her heart rate starts panicking. She gets tingles down the arm. Thought she was having a heart or panic attack. It has gotten worse as the week has progressed. It was worse on Sunday; even worse on Monday; worse yesterday and she was crying. She has also been stressed at work. Doesn't know whether to go to the doctor or an urgent care, or if she needs to. The patient is 66 years old and says she is in fairly good health. Right now she is unable to lift her arm and has tingles in the hand and down the arm. The pain makes her catch her breath. If this gets much worse she is going to go have it checked out. Again mentions that she has been having stress. It does seem to be a little worse. The patient experienced thought she was having a heart or panic attack on Mar2021, stress, heart rate, panic on Mar2021, soreness from the shot on Mar2021, soreness to left arm, hurts in chest around breast, back, shoulder blade on 23Mar2021, unable to lift arm, pain makes her catch her breath/ difficult to take a deep breath on Mar2021, tingling in hands and down the arm on Mar2021, and crying on Mar2021. The outcome of the event Soreness to left arm, hurts in chest around breast, back, shoulder blade was not recovered while for the rest of the events was unknown. Prior Vaccinations (within 4 weeks) was None. She had an unspecified shot but reiterated no vaccines. No AEs following prior vaccinations.
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| 66 | 2021-04-22 | anxiety |
Ringing in both ears, increased anxiety, increased pain level for current conditions, new pain in ba...
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Ringing in both ears, increased anxiety, increased pain level for current conditions, new pain in back of head, swelling of left thumb joint and wrist with intense pain, loose stools, rapid heart beat that comes and goes
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| 66 | 2021-04-24 | disorientation, mental status changes |
Presented to ED with acute mental status changes-disoriented, weakness, poor PO intake. O2 sat 95% o...
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Presented to ED with acute mental status changes-disoriented, weakness, poor PO intake. O2 sat 95% on Rm air. Treated with bamlanivimab-etesevimab. She remained on room air and hemodynamically stable throughout the remainder of the admission.
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| 66 | 2021-04-24 | feeling abnormal |
swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ ...
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swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ achy pain; She couldn't straighten it out or bend it all the way down, it was like it was locked; joint went stiff and the pain; joint went stiff and the pain; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration at left upper arm 10Mar2021 at 12:30 (66-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included thyroid, and "had stem cells put in her hip". Concomitant medications included ongoing thyroid (ARMOUR THYROID) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) via an unspecified route of administration at left upper arm 17Feb2021 at 14:00 (65-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient previously received the second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for shingles and felt like we were getting the flu and the next morning was fine. Patient states she had stem cells put in her hip and was (medical office name) for an x-ray to see how it's doing. She showed a nurse practitioner her hand and nurse practitioner said patient needs to report that. Patient states it swells right under her finger, swelling under her middle and ring finger. The joint went stiff and the pain. She can't bend her fingers, it is mostly her ring finger. She couldn't straighten it out or bend it all the way down, it was like it was locked. Following her second vaccine dose she has had pain in the center of the palms of her hands and bottom of her feet. The pain is inconsistent as it comes and goes. The feet pain come and go not bad like the hands. The middle of the palm pain comes and goes and the joint on 1 finger never did get better, it is worse at night and a teeny bit better in the morning. She felt pain in 1 of her feet for a moment yesterday and not continuous like her hand. The left hand is not swelling, the center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like, it is an achy pain. States she kept telling her husband she has pain in the center of her hands and on the bottoms of her feet and feels like she is about to have a break out and didn't. Patient states it has been a month since she had the 2nd vaccine. States the symptoms all started within 24 hours of the 2nd vaccine. On 07Apr2021, nurse practitioner put a lubricant injection (name unknown) into her hand where the swelling was. Patient was told it was a lubricant that might help, and it has helped some. It is moving a little better today after the injection but she still has pain. Adverse events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the event "swells right under her finger" and included lubricant injection. The outcome of swells right under her finger, joint stiffness, and joint lock was recovering; other events were not recovered. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-25 | feeling abnormal |
27 minutes after the shot of Pfizer/BioNTech Covid vaccination, I felt a systemic change throughout ...
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27 minutes after the shot of Pfizer/BioNTech Covid vaccination, I felt a systemic change throughout my body of acute onset. It lasted for 4 minutes. It is difficult to describe and I never felt anything like that before. It was NOT fatigue, nausea, dizziness, difficulty breathing, heat, cold, or a feeling of tightness. I had no blurred vision, rash or itchiness. However, the feeling was physical and strong, experienced throughout my body. The best I could describe would be a flush without heat and a sensation that something was going very wrong. I took my pulse which was about 84.
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| 66 | 2021-04-25 | feeling abnormal |
Headache, severe brain fog, dizziness, vertigo, loss of balance, nausea. It started 8 days after the...
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Headache, severe brain fog, dizziness, vertigo, loss of balance, nausea. It started 8 days after the shot, and still feel that way 4 days since. Took ibuprofen once which might have helped a bit for a little while.
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| 66 | 2021-04-26 | feeling abnormal |
dizziness; She lifted her head and the room was spinning. It as weird. It has abided somewhat. She i...
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dizziness; She lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: N6201) via an unspecified route of administration in Left arm on 14Feb2021 17:00 as single dose for COVID-19 immunization (66-year age at Vaccination). The patient medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer and experienced dizziness on 15Feb2021 6:15 am at the gym, the patient had to stop and drink water. The patient doesn't see that listed unless a side effect of severe allergic reactions. She is wondering if this is a side effect. On an unspecified date in 2021 she lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy. She has a friend who is a nurse who said her fellow nurse had her first dose of the vaccine and had dizziness as well. She doesn't have that nurses information but will pass on that she should call in and report as well. Outcome of the events was not recovered.
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| 66 | 2021-04-26 | loss of personal independence in daily activities |
Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong head...
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Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong headaches were common & continue; She had lost a week of her life trying to keep warm; This is a spontaneous report received from a contactable other healthcare professional (patient). A 66-year-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in left arm on 10Feb2021 at 09:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization in Public Health Clinic/Veterans Administration facility. Medical history included allergic to dust, mold, mildew, hay, cat & rabbit hair. Concomitant medications included atorvastatin, cetirizine, amlodipine, all received in two weeks. No other vaccines received in four weeks. The patient previously took moxifloxacin hydrochloride (AVALOX) and had allergies (Bayer wide spectrum antibiotic). The patient had not been tested for COVID prior vaccination. It was reported that 10 hours after receiving the vaccine Temperature dropped to 94.3 on 10Feb2021 at 08:00 PM. For next 8 days it has varied as sub-normal from 95 to 97.6, mostly ranging from 95.4 to 96.5. Had a very sore arm for two days with swelling in gland under the arm. Strong headaches were common & continue. Eight days out that swelling is still going down. The doctor visit was a waste of time & money. They knew little & couldn't offer any suggestions. She was afraid to get the second shot because the doctor did tell her side effects would be worse with that one. She had lost a week of her life trying to keep warm. Her temperature did go up to normal & past on day 8 after she was in a very hot vehicle for 1/2 hr. Events resulted in visit to Doctor or other healthcare professional office/clinic. No treatment received for events. The patient had not been tested for COVID post vaccination. The outcome of events was recovering. Information on lot/batch number has been requested.
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| 66 | 2021-04-26 | nervousness, insomnia, anxiety |
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li...
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nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-04-26 | sleep disorder |
I had a sudden onset of a loud pitch sound in my R ear that woke me up then it was intermittent but ...
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I had a sudden onset of a loud pitch sound in my R ear that woke me up then it was intermittent but after getting the 2nd dose it is almost constant. I have seen by ENT 3x and had hearing test done 2x. Hearing showed mild hearing loss that I was already aware of as self discovered 2 years ago. Can only sleep because I started back taking prozac 40mg, and clonazepam 1mg at bedtime. Xanax 1mg taken during the day to help me relax. These are Rx'd.
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| 66 | 2021-04-27 | restlessness |
101.6 fever for 2 1/2 days; headache; joint and muscle pain; joint and muscle pain; stiff, sore neck...
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101.6 fever for 2 1/2 days; headache; joint and muscle pain; joint and muscle pain; stiff, sore neck; chills; sweating; fatigue; restlessness; lack of appetite; injection site pain; swelling in left armpit; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient (non-pregnant) received second dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included Hay fever, known allergies to Sulfa, Penicillin. The patient's concomitant medications were not reported. Patient previously took cefalexin (KEFLEX) and had drug allergy. The patient received first dose of historical vaccine, bnt162b2 (Lot: EN5318, product: COVID19, brand: Pfizer) in left arm on 26Jan2021 10:30 for covid-19 immunisation. The patient experienced 101.6 fever for 2 1/2 days, headache, joint and muscle pain, stiff, sore neck, chills, sweating, fatigue, restlessness, lack of appetite, injection site pain, swelling in left armpit on 16Feb2021 around 19:30 and lasted until Friday (19Feb2021) 3 days later with slight injection site pain and slight neck and underarm pain still lingering. Remained in bed all Wednesday, Thursday and some of Friday. The patient underwent lab tests and procedures which included body temperature: 101.6 fever for 2 1/2 days on 16Feb2021, sars-cov-2 test via Nasal Swab the Rapid and PCR: negative on 03Feb2021. The Clinical outcome of all the events was recovered on 19Feb2021. Information about lot/Batch number has been requested.
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| 66 | 2021-04-29 | nightmare |
I have had a DAILY dull headache at the top of my head plus an ache at my lower neck since receiving...
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I have had a DAILY dull headache at the top of my head plus an ache at my lower neck since receiving my second vaccine shot. On April 29, I had a nightmare during which I screamed in my sleep--I woke up with an aggravating headache. It seems as though my stress hormones are triggered with the least bit of stress--even in a sleep state. I'm wondering whether the ingredients in the pfizer vaccine are similar structure as the hormone cortisol.
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| 66 | 2021-05-04 | disorientation |
Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat ...
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Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat and chest; tightness in throat and chest; dizziness; disorientation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 as single dose for covid-19 immunization in an hospital. Medical history included reaction to preservatives in foods, products, and medications from an unknown date. The patient's concomitant medications were not reported. The patient previously took sodium metabisulfite and experienced anaphylaxis. No other vaccines taken in four weeks. No COVID-19 prior to vaccination. On 08Mar2021 18:00 the patient experienced anaphylaxis reaction immediately post-vaccine, difficulty speaking, hoarseness, tightness in throat and chest, dizziness, and disorientation. The events required emergency room and physicians office visit and were considered life threatening by the reporter. The patient was treated with Epinephrine, Benadryl, Prednisone, and Pepcid. The patient was tested for COVID-19 via nasal swab post vaccination on 08Mar2021 with a negative result. The outcome of the events were recovered with sequel. Information about lot/batch number has been requested.
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| 66 | 2021-05-11 | mental status changes | J18.9 - Pneumonia, unspecified organism ALTERED MENTAL STATUS VOMITING |
| 66 | 2021-05-12 | feeling abnormal |
Sore injection sight when in motion. Woke 3:00 a.m. massive headache. Took one Advil, back to sleep...
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Sore injection sight when in motion. Woke 3:00 a.m. massive headache. Took one Advil, back to sleep. Up at 5am Feeling a bit "off" Tired, later (10:00 am.) nausea, a little hyper, dizzy and noticeably off balance. Now 11:30 am, back to bed.
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| 66 | 2021-05-14 | excessive sleepiness |
visual and neurological issues; She says she got her phone and it affected her brain; her fever went...
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visual and neurological issues; She says she got her phone and it affected her brain; her fever went down; She gives her height and says that she shrunk; hoarse was reported as worsened; hoarse; slept a lot; 12 to 16 hours for the next 5 days; trouble walking; trouble seeing; This is a spontaneous report from a contactable other nurse (patient). This nurse reported 2 reports for same patient, this is first of 2 reports. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 25Feb2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing asthma, she says she has been having respiratory problems and asthma since she was a teen; covid-19 from 06Feb2020 to 18Feb2021, She says she didn't see her doctor until the day she got better. She says she realized she was in big trouble and need help. She says she got her phone and it affected her brain. She says she she 5 sons and she flipped around her phone having trouble. She says he has had the same phone for 4 years. She says she was fine that day, 18FEB2021, that she had half of the symptoms, and her fever went down. She says the headache lasted a while; allergies; No thyroid gland, clots; thyroid cancer; termors that started 7 years ago in one hand. She says she has no thyroid gland. She says she has been taking this since her surgery; she was around 33 years old, and she is 66 now, so for 33 years. She says she had clots. History: She says she takes a lot of medications, a lot of neurological medications. She says the only other pertinent thing is she does have tremors that started 7 years ago in the one hand. She says just before she got the COVID virus, a week before, tremors started in the other hand and progressed rapidly. It is remarked that she thinks she was infected when this started. She says the other one took 7 years to be once a day while this one progressed to be daily. She says she does not take anything for that, she is just trying to increase her activity levels. She says when she was 30 or 40 she was very active. She says the doctors think there is something wrong with her immune system. She says they are trying her on diff medications for asthma; they changed it, added more. She says Advair work beautifully and she doesn't use a breakthrough inhaler. She says ever since COVID in 2020, the first week of FEB2020 she thought it was the flu. She says she didn't get any medical help, she was in severe shape, and her headache was severe. She says she crawled to the bathroom once a day, she had a high fever and it felt like a snake effect of a cobra all over, squeezing. She says her pulmonologist gave her Spiriva and that has opened her up, once a day. Caller had gotten to the point she couldn't take 5 or 6 steps and couldn't breath. She gained a ton of weight cause she couldn't move related to this breathing issue. She thought she wouldn't recover, he gave samples once a month. She says she saw him a week ago, 10 days ago maybe. She says she had shortness of breath and couldn't walk. She clarifies she is talking about when she had COVID last year, not this current shot report. She says she didn't consider these current side effects a problem, she expected some side effects and they went way. She says the shortness of breath walking problem was due to shortness of breath; that was what happened with COVID. She says her hoarseness is related to spring allergies and is due to the climate and it is usually from 10APR to 16JUN. She says she gets a sinus drip and congestion and that she is on 5 different medications for that. She says she has more trouble with inhouse allergies. She says she gets trouble as soon as the trees pop. She has had hoarseness for about a year and the allergies have really started around 10Mar2021 for this year. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) taken for thyroid cancer. She says something new was 8 weeks out she got the flu shot. She says she has a lethal allergy to egg white so she has never had a flu shot her entire life. She says she asked her doctor why they didn't get the one without egg whites. She says they made one without egg white in the 1990's. She says 08DEC2020 was her first flu shot. She says everyone wants her to take more shots but she won't take any more. She says COVID and the flu shot are enough for one year. She says if they have the COVID booster then she will take that one but not any other. She says no but she was told don't ever have anything with egg white in it so she never had the flu shot, she refused. The patient took first dose of BNT162B2 on 04Feb2021 for COVID-19 immunisation and experienced headache. The patient experienced trouble walking (Disabling) on 25Feb2021 19:00 (about 7:00pm in the evening) with outcome of recovered on 25Feb2021, trouble seeing (Disabling) on 25Feb2021 19:00 (about 7:00pm in the evening) with outcome of recovered on 25Feb2021, hoarse was reported as worsened (medically significant) on Mar2021 with outcome of not recovered, hoarse (medically significant) on Mar2021 with outcome of not recovered, slept a lot; 12 to 16 hours for the next 5 days on 25Feb2021 22:00 (10:00pm at night) with outcome of recovered on 2Mar2021. The caller is calling about the COVID 19 vaccine. She says she had side effects but she would consider them mild. She says the shot was wonderful. She says she has put off reporting this. Caller remarks she has shrunk, when providing her height. Caller apologizing when clearing her throat, says sorry she is so hoarse today. She says the second dose they came and went away. She says the second shot was at 11:00 am. She says the second shot was on 25FEB2021. She says she had a lot of water to drink then 7 hours after the second shot, about 7:00pm in the evening, she had 45 minutes of visual and neurological issues. She says she had trouble walking, she was stumbling with her feet, she had trouble with eyesight, different sections of her vision was together. She says this was like when she had 5 children. She says her pregnancy during the first 3 months she had neurological visual experiences of shadows put together and at the end of the pregnancy, 2 months after delivery, it would go away. She says she is in an apartment and she sat down then it was 45 minutes total for both occurrences at the same time. She also reports that she slept a lot; 12 to 16 hours for the next 5 days. She says on the 6th day she was fine, no symptoms and no sleepiness. She says it occurred the evening at 10:00pm at night, then it went up through the 5th day afterwards. When asked seriousness of the sleeping event she says none of the above. She says she she lives in a senior housing area, they all got it at the same time, that there was only one person who declines. She says almost everyone had sleepiness for at least 3 days afterwards. She says she is still battling the COVID after effects, it was disrupting her breathing. She says she was glad she got the shot, she is glad she was able to do it. She says her second dose seemed to be around 11:00am. For the second dose lot number she reads GL92 then AA or 00. She does not see an expiration date or NDC number for the first or second dose. She says her second dose was in her left arm up high near the shoulder, upper arm high. She says she didn't feel either of them. She says that she was put on BREZTRI Expiration date, lot number, and NDC number not provided. She says her doctors thought she had COPD but she didn't; it doesn't work for people over 70. She says the cardiac problem was with a respiratory medication. She says it was Trelegy. She does not have an expiration date, lot number, or NDC number for Trelegy . She says she is not sure where she put the container but she does have it somewhere. She says it affects the QRS. She says when she had COVID she was sneezing and in August her hair fell out. She says she had a fever for 4 days that week then she went away. She says she wondered if she had the long haul COVID. She says the doctor gave her something to make her lungs spring open. She says she is currently hoarse due to spring allergies, not because of the shot. A medication called Breeze didn't work for her. She says that she was put on BREZTRI Expiration date, lot number, and NDC number not provided. She says her doctors thought she had COPD but she didn't; it doesn't work for people over 70. No additional vaccines administered on same date of the Pfizer suspect. All events did not require a visit to Emergency Room or Physician Office. No family medical history relevant to AE. No relevant Tests. The reporter considered events trouble walking, trouble seeing, slept a lot; 12 to 16 hours for the next 5 days were related to covid 19 vaccine, event hoarse was unrelated to covid 19 vaccine. The outcome of other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information there is not a reasonable possibility that the drug contributed to occurrence of the events, a possible contribution of the drug to the event pyrexia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate –data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021493623 same patient/drug, different vaccine dose/event.
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| 66 | 2021-05-17 | feeling abnormal |
Heaviness in Breathing/breathing problems; felt different; not feeling good; Aggravated Asthma; horr...
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Heaviness in Breathing/breathing problems; felt different; not feeling good; Aggravated Asthma; horrible acid reflux/ Aggravated Acid reflux; was in pain last night/she was really hurting; blood pressure was sort of up to like 185 over 186; Chest pain; back for stabbing pain; Pressure chest; Wheezy; This is a spontaneous report received a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not reported), via unspecified route of administration in the left arm on 01May2021 (at the age of 66 years-old) as a single dose for COVID-19 immunization. The patient's medical history included a "heart condition", asthma, acid reflux, hiatal hernia, and being "allergic to a lot of medications", reporting that she previously had to carry an epinephrine (EPIPEN). The patient had unspecified concomitant medications. The patient stated that immediately after the first dose, she started not feeling good (01May2021), and by the time she got home, she was really having some breathing problems (01May2021). She was monitored at the vaccination site for 30 minutes after administration, but did not report to them, because she did not know what to tell them. She a history of asthma, so she treated with her inhalers, and "it eased off a little bit". She reported she was really hurting, so she took a 5 mg dose of prednisone tablet. She also reported horrible acid reflux later that night (01May2021), which can trigger her asthma, she took some aluminum hydroxide/ magnesium hydroxide/ simethicone MYLANTA and felt much better. She slept propped up, took another dose of MYLANTA this morning, and was feeling better today, but not 100%. She wanted to know if the vaccine can cause acid reflux or asthma exacerbations? And if she should expect the same, but more severe reactions after the second dose? It was also reported, that after the vaccine, the patient stated for fifty minutes maybe she had what was like pressure in her chest (unspecified date May2021). She did not know what she was feeling, so she did not say anything. So she came home, and just as the day got work more the pressure, she had asthma and saw what was happening was an asthma attack, which started hurting really bad like an asthma attack, so she took her inhalers, and it eased it off a little bit. Then it just kept worsening. She was also a heart patient, so when she had asthma, some times it mimicked a chest pain. She was thinking if it was affecting chest pain or was it asthma, so had some prednisone, 5mg of prednisone (treatment) that she had to take for her asthma. It did not help last night (further clarification unknown). She was trying to get to the hospital. She was wondering if this shot had aggravated her acid reflux and aggravated her asthma (both 01May2021). When the patient went to bed, she got some aluminum oxide/ magnesium hydroxide (MAALOX), big dose of MYLANTA, and that eased it off. Before she got the shot, she felt fine; she would have no symptoms, and then when she got the shot "mean it went 30 minutes later and I just felt this and I still did not know what it was". Her husband told her to sit down. She did not know what was wrong, she just felt different. She thought it caused her asthma to act up. The patient stated that last night (01May2021), her blood pressure was sort of up to like 185 over 186, "but I think it was because I am extreme so bad by then I am and my chest in my chest and then I finally said okay let me take so (incomplete sentence) my acid reflux so let me take some MYLANTA so I take calcium carbonate/ magnesium hydroxide (ROLAIDS) and I immediately stop that pain that must be my acid reflux making triggering my asthma it is, I was like, I was in pain last night (01May2021), just administered for my asthma between my chest and my back for stabbing pain (01May2021) and that caused sometimes when I have heart condition, I always like it is my heart or it is my asthma what is it? and I got this one okay I will take a dose of MYLANTA just to make sure see that will help come down". The patient felt a lot better today, but still felt sort of wheezy (May2021) "like you know when you have asthma". Her bad asthma she would just get a wheezy sort of just heaviness in breathing. The patient was due to get the second shot on 22May2021. On an unspecified date, the patient had: a lab test "but have results before I had the following to chest by giving lastly", and routine blood work-cholesterol and all. The outcome of the events wheezy, heaviness in breathing/ breathing problems, horrible acid reflux/ aggravated acid reflux was recovering. The outcome of other events was unknown. Information about lot number has been requested.
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| 66 | 2021-05-23 | anxiety, panic attack |
Within 5 minutes of vaccine administration, patient appeared shaky and reported tightness in throat....
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Within 5 minutes of vaccine administration, patient appeared shaky and reported tightness in throat. Pharmacy staff suspected anxiety/panic attack as symptoms appeared to be triggered by pharmacist stating that patient must remain on site for a 15 minute observation period in case of an immediate and serious reaction. Out of an abundance of caution, EMS was called and reported to the pharmacy. EMS stated airway was clear, and patient did not appear to be in anaphylaxis. Because patient was wheezing, epinephrine was administered, and patient was taken to local hospital. Patient was discharged around 10:00pm (approximately 5 hours after the incident).
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| 66 | 2021-05-25 | feeling abnormal |
get sore arm; Anaphylactic reaction; Shortness of breath; look miserable; This is a spontaneous repo...
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get sore arm; Anaphylactic reaction; Shortness of breath; look miserable; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 09May2021 (Lot Number: EW0177; Expiration Date: Aug2021) at single dose for COVID-19 immunization. Medical history included asthma since she was 8 years old, when she was a child her asthma was really bad and then she would say after 2004, she would say she went to chemotherapy and then 2005 her asthma got a lot better, didn't have it really bad as she used to, one doctor said he had heard that from patient they go through the chemo and their immune system change, she carried her little inhaler, but she don't have (incomplete sentence), she had asthma but not really bad, she was not like walking around every day with asthma packs but she have asthma and she keep little inhaler, for eg; if there is lot of pollen in air then she will need to take out her inhaler; breast cancer; seizure; hypertension, high cholesterol. Concomitant medications included zonisamide taken for seizure, lacosamide (VIMPAT) taken for seizure, losartan taken for hypertension, atorvastatin taken for high cholesterol, all start and stop date were not reported. Some years ago when she in 2005 when she was on the end like she said its 2005 and she was right on the end of being treated for breast cancer. she was taking, the doctor put her on Tamoxifen and she woke up one morning to really short of her breath and she thought it was her asthma, so the lady she was staying with said you look miserable and she said let her get back on the store and have her take her to the ER she said call now and it turned she had a blood clot in her lungs but 'Dr PRIVACY' (not spelled) who was treating her, he was a cancer specialist he said PRIVACY she was so proud of her, he said that she got to take you off the Tamoxifen, it was that Tamoxifen that caused blood clot in your lung. A blood clot in the lungs was the side effect of the Tamoxifen. Tamoxifen was one of the drug they give women who have had breast cancer and are right at the end of the treatment and put us on Tamoxifen and she ended up with a little bit of blood clot in her lungs. He said that was one of the effects of Tamoxifen. So, that was like in 2008, 2009 it was 12 years ago, could have 11 years ago but this goes to show her body may have potency for allergic reaction. The patient stated she had short of her breath because she did have allergic reaction shortness of breath with Pfizer Vaccine first dose at a pharmacy yesterday 09May2021, had been given Prednisone so. She did shortness of breath about 45 minutes after she took it because we had to sit there about she would say we were sitting there about 20 minutes and he finally said well you all can get up and leave and then about say 15 minutes later she start getting shorter and shorter of her breath. " The patient stated, she just needed to Pfizer certainly reporting acting as if this was just a completely safe vaccine there are unsafe reaction to this vaccine so she wanted to get this going okay, she was 66 years old she end up going to the ER, they didn't give her Epipen' (not clarified further) so that's when she started to get sore arm, she had an anaphylactic reaction to this drug. Now if this was the wrong number to report it to then she would call to get to agency she needed to report it to. she was on the Prednisone now. Sometimes it was difficult for she to breathe, so the emergency room they 'have' (not clear) she up with enough medication now, so she had got plenty of medication now." She stated it just happened yesterday, when she saw on the news that they hadapproved it to be for children and it bothers me that they, this was just a break simple drug no very safe. Yesterday when she first started getting short of her breath she was in denial and didn't want to because she was really started shorter of my breath and the pharmacist that administered he even said he knew that it was the reaction to the drug because she was full animated before he administered the vaccine because she was sitting there talking to the two ladies and you know jabbering and remember the days because of flu shots and how the government used it, they didn't wanted knowledge when people talked about how the flu shot (Unspecified Shot) made them sick and she was just jabbering so he knew it was reaction to the vaccine. Here was this lady 'who was so animated and talking and now she can barely hold her head up' (not clarified further). Patient confirmed Prednisone as treatment. As for the treatment patient stated, "Took the 2 Prednisone and what happened was, if I wasn't even going to go get Prednisone, but the shortness of breath was going transient, what I mean is first of all I talk and I do fine and then all of a sudden I get short of my breath again and then looked like I had a good night and then I woke up and my lungs tightened up again and then earlier this evening I called on phone and tell them I have to take Prednisone because my breath was getting short again." Prednisone details were 10 mg 4 tablet by mouth every day for 5 days then 2 tablet every day for 3 days, so 1 every day for 2 days. As for other medications: patient stated she was on seizure medications daily. She was on treatment for asthma, she had a little inhaler she keep in her purse for eg; if there's pollen in the air, when she got out and then maybe get short of her breath if there's pollen in the air yeah she need her little inhaler, but she was on daily treatment for her seizures she was on 800 mg a day for the seizures, Zonisamide and Vimpat. In fact that day she wouldn't take any other medication because she thought well she was not taking any other medication' (not clarified further) to mix it with this vaccine. Normally she take the 25 mg for high blood pressure but she won't take it that day she think it's called Losartan or something. Little bit of high blood pressure they cut that down because her blood pressure had gotten, she had some high blood pressure yes it's called 25 mg of Losartan. Yeah she thought, she won't take it that morning because she though well just lay off all of that stuff that day and so we can take the vaccine, 'mix none of that with vaccine' (not clear), that day the only medication that she was taking was her seizure medication (Zonisamide and Vimpat) because you can't skip medication but the Losartan and Atorvastatin that's for high cholesterol she won't take that either that day. The asthma now, she did have asthma but it's a kind of that's one the things that you have it but you are not on daily medication for it. She do keep her inhaler with because sometimes she go in buildings where they have air condition on really high and it gets to her lungs. In fact when this happened and the guy wanted to call 911 we decide well let's see if new inhaler (Unspecified Medication) worked and it wasn't quite rescuing her lungs like it should." For Vimpat details patient stated, it's a pill (formulation not clarified further), it's 100 mg so she took one in the morning and one in the evening. For Zonisamide details patient stated, Each capsule was 100 mg, so she take two 100 in the morning and two 100 before she go to bed." As for lab Test patient sated, "Just had a MRI but no dye just the plain MRI with no dye or anything. Had MRI without dye, no dye." hen probed for the MRI result, consumer stated, "No because this was the seizure doctor ordering that." As for date of MRI patient stated, "That was on the 4th I think, but what was the MRI have to do with having a reaction to this vaccine, because the MRI. Doctor want specifically had no dyes it was just no dyes but that was the doctors that treat me for seizure he wanted the MRI done, yeah this was the 4th of May." When probed if adverse events are improved, worsened or persisting, consumer stated, "today you know just a short of the breath I am really short of my breath but now when I have taken the Prednisone I am breathing a lot better, breathing so much better yes, you can mark improve (not clarified further)." The outcome of the event shortness of breath was recovering, of other events was not recovered.
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| 66 | 2021-05-26 | feeling abnormal |
Headache immediately; chills; Fever; Joint pains; Muscle aches; Fatigue; Nausea; Red bump at the inj...
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Headache immediately; chills; Fever; Joint pains; Muscle aches; Fatigue; Nausea; Red bump at the injection site; At 1:00pm this afternoon I can say I am feeling like all systems are gone; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 at 12:30 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 (tested positive prior to vaccination). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID -19 immunization, on unspecified date. The patient previously took Levaquin and experienced allergies. On 09Feb2021 12:30 after vaccination the patient experienced headache immediately, then took a 2-hour nap when patient reached home. In the evening patient experienced with chills, fever, joint pains, muscle aches, fatigue, nausea along with the headache. The next morning, patient was not better so called her provider and was told to take Tylenol 2 doses before patient noticed the change in the flu like symptoms. After the 3rd dose of the Tylenol before patient got relief from the headache. Patient slept the entire day and got up at 5:00 pm and had a chicken soup and went back to bed and slept all night. When patient woke up in the morning, she felt so much better. Patient's arm was still sore, and the pain had gone down into her armpit and had a red bump at the injection site but no fever. At 1:00pm afternoon patient said she was feeling like all systems were gone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient took Tylenol for treatment and the outcome of the events was recovered on 11Feb2021. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
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| 66 | 2021-05-27 | sleep disorder, loss of personal independence in daily activities |
After my first vaccine I experienced the usual headaches, tiredness and a left sore arm. My right s...
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After my first vaccine I experienced the usual headaches, tiredness and a left sore arm. My right shoulder and right hip started to hurt and was becoming painful at times but I did not think anything of it. After my second vaccine, I experienced left sore arm and about five days later my left hip pain and left shoulder pain again started to hurt. I had a hard time positioning myself in bed. Then when my pain started to go to my left side of my left shoulder I started to get concerned. On 04-09-2021, I stepped on a ladder and that is when I felt my hips a bit off. I went to see a doctor who told me I had reactive polyarthralgia in my joints. My doctor placed me on 20mg prednisone 2x a day. I went to see my family doctor who did tests, all which were negative and one test showed that I had inflammation in my hip joints. I also had trouble getting dressed. My hips are better today, but I still cannot lift anything heavy. This week my family doctor put me on a Medrol dose pack and prednisone medication. I also started physical therapy the day before yesterday. At times I feel my right hip is worse than my left. I also feel my muscles are tight in my shoulders and have trouble grasping objects.
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| 66 | 2021-05-28 | feeling abnormal |
it seems like respiratory infection; Shortness of breath; Something going on in the middle of her ch...
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it seems like respiratory infection; Shortness of breath; Something going on in the middle of her chest; Body aches; Coughing; Swelling on arm; Soreness in the arm/her arm was hurting; sick; Totally tired; waking up and having to go back to sleep; Not been feeling well/she is feeling like she is 99 years old; Felt so bad,Not been feeling well/she is feeling like she is 99 years old; Heart palpitations; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 19Apr2021, as single dose, for COVID-19 immunization. Medical history included has asthma that was controlled for years and allergies that were controlled. The patient's concomitant medications were not reported. She got the first dose of the vaccine on 19Apr2021 and was okay, except her arm was hurting/ soreness in the arm for a few days approximately on an unknown date in 2021. She was ready to get her second dose on 10May2021 but the week prior to that, approximately in 2021, 2 weeks after the first dose, she started getting sick. Caller reported that in to that third week, approximately in May2021, she experienced shortness of breath, coughing and body aches and it all hit her like a ton of bricks. She was feeling great but then was feeling Covid symptoms. The caller was totally tired, she was also waking up and having to go back to sleep on unknown date in 2021. The caller called the nurse line, and they told the caller to go into the emergency room. They did a covid test first thing because a lot of the symptoms were Covid symptoms. On an unknown date in May2021, they did an electrocardiogram (EKG) on the caller because she was having something going on in the middle of her chest. The caller had a covid test in the emergency room and it was negative. They did some blood tests, and they did not see anything bad other than a respiratory infection and said come back if it gets worse. That's what they thought it was and they sent the caller home. She also had heart palpitations on an unknown date in 2021 and stated she needs to go see a cardiologist. The caller was apprehensive about getting the second dose right now because she was still not feeling well. She does not know what is going on with her body. She was there in the ER on a Friday and asked if she should get the shot on that Monday or Tuesday and the ER doctor said to get it. However, she talked with the Immunization department and they said not to get it if she is not feeling well. She kept rescheduling the vaccine because of her symptoms. She stated she was feeling like she was 99 years old. She had an appointment with her primary care provider this week and they said they will listen to her heart. She was still delaying getting the second shot and was thinking it was best not to get it. She stated she read that adverse reactions usually occur within the first hour. The immunization clinic said to delay the second shot, that the caller could delay it up to 31 to 42 days. The caller has not been feeling well for weeks. The caller is still having difficulty breathing and has been taking her asthma inhaler. The caller was feeling great except the soreness in her arm that went away. The caller was seeing her primary care provider this week because she doesn't know if she needs to have her heart checked out further. The facility wouldn't give the caller her second dose at her scheduled appointment because she was feeling bad, so she has kept delaying it. The outcome of the event soreness in the arm/her arm was hurting was recovered on unknown date in 2021. The outcome of the events shortness of breath, not been feeling well/she is feeling like she is 99 years old and felt so bad, not been feeling well was not recovered. The outcome of the events respiratory infection, something going on in the middle of her chest, heart palpitations, coughing, swelling on arm, body aches, sick, totally tired and waking up and having to go back to sleep was unknown. Follow up attempts needed. Information related lot/batch number has been requested.
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| 66 | 2021-05-28 | loss of personal independence in daily activities, impaired work ability |
Severe aching, stabbing pain and tenderness of left arm and chest muscles. Pain and stiffness causi...
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Severe aching, stabbing pain and tenderness of left arm and chest muscles. Pain and stiffness causing limited range of motion in left arm and shoulder. Pain radiating into my clavicle area . Inability to do all of my activities of daily living without limitation and severe pain. (ie. bathing, putting on clothing, normal house duties) Difficulty doing my daily online business affecting my income due to the pain and distraction from the pain. These symptoms/signs have persisted since 4/6/21.
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| 66 | 2021-06-01 | agitation |
Tired; Stomach ache; eyes were itching; itchy throat; flushing; itching; ears were hot to touch; agi...
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Tired; Stomach ache; eyes were itching; itchy throat; flushing; itching; ears were hot to touch; agitation; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female non pregnant patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: en6203), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:00 (at the time of 66-years-old), as first dose, single, for covid-19 immunisation. Medical history included high bp (blood pressure) and known allergies to codine, latex, morphine, penicillin. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. The patient previously took cortisone, hydrocodone, morphine and had allergies. Concomitant medications included lisinopril at 5mg; colecalciferol (VITAMIN D, strength: 10000 IU) at 10000 iU; fish oil; curcuma longa (TURMERIC). It was reported that 24 hours after the injection patient had flushing, itching, agitation, itchy throat, my ears were hot to touch and very itchy, my eyes were itching as well on 23Fe2021 14:00. I took allergy medicine, day three horrible stomach ache (25Feb2021), not flu-like it was the pain associated with past allergic reactions to pain meds. The patient did not feel the need to throw up the fourth day was just tired (26Feb2021). Therapeutic measures were taken as a result of itchy throat, flushing, itching, ears were hot to touch, agitation, eyes were itching. The outcome of the events was resolved. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-06-01 | feeling abnormal |
Fast heart beat; Palpitations; it make me feel real bad and it is going; Stress; Tired; This is a sp...
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Fast heart beat; Palpitations; it make me feel real bad and it is going; Stress; Tired; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Mar2021 (Batch/Lot Number: ER8727) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure high, asthma, thyroid, cholesterol, allergy. Patient stated "I take medications. I have high blood pressure. I am asthmatic, I have asthma and allergy. I take lot of medications. I take thyroid medicines, I take inhaler for my asthma (Captured as per verbatim), I have eye drop latanoprost (not spelled, further clarification unknown) and I take cholesterol medicine." Patient stated "I had rapid, fast heart beat the same day. They gave me a paper and I took it that if I have any of these features then I should not have the second vaccine. I had one of those, I had palpitations and it made me feel real bad and it is going, I don't know what is going on so when I had after an hour I had the shot, I still had the palpitations. I drive back home I live by myself so I feel really bad I didn't know what happened so finally the next day I went to the emergency care because I figured out that I might be having palpitations they say yeah you have and there is nothing we could do about so finally after 3 days they stopped they used to come off and on right after the shot like three 3 days in a row and then it finally stopped, then I went to the Cardiology, they telling me I guess I have age but now I have the real stress and tired. So the shot, I guess, it started it for this started to happen to me when I had the shot. So, I would not take the shot but I have my doctors, and when I called them to talk, they would tell me just take the second shot. When I read the CDC guidelines, I should not take it, and then there are my doctors. I am trying to say that I wouldn't take it and my doctors, some of my family members, so what do I do? I don't want to go through that again and it was really bad, I thought like I was going die. I didn't take my second shot and my doctor, they were little upset with me and my children that if you have that bad reaction and you feel that bad then you should try to take it anyway I guess the second one would kill me so it's okay, I don't have to worry about the virus because I won't be there. I had a EKG right after because of my heart palpitation. No, I had no treatment. They are trying to find out if I have a heart problem. So I had EKG which shows that I had the palpitations and then I am scheduled to have echocardiogram, another heart test next week." Outcome of events fast heart beat, palpitations, and 'it make me feel real bad and it is going' was recovered, of remaining events was unknown.
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| 66 | 2021-06-03 | feeling abnormal |
Mid day, day after vaccine: fatigue.Entire week following the second day: Foggy brain, minor headach...
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Mid day, day after vaccine: fatigue.Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; Very mild Headache/minor headache; Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; This is a spontaneous report from a contactable physician. A 66-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EL9264) via an unspecified route of administration, administered in Right Arm on 23Feb2021 at 12:00(at the age of 66years) as 2nd Dose, Single Dose for COVID-19 immunization.The patient's medical history included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Right Arm on 02Feb2021 at 12:00 as 1st Dose, Single Dose for COVID-19 immunization, Known allergies: Sulfa drugs (mouth ulcers).The patient had taken Estradiol patch, Levothyroxine 112mcg, Calcium sup within in two weeks of vaccination. The patient did not take any other vaccine within 4 weeks of vaccination. On 24Feb2021 at 12:00,the patient experienced fatigue, very mild headache/minor headache, feeling abnormal, head cold. No Treatment was received for the events. The outcome for the events was recovered/resolved.
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| 66 | 2021-06-03 | feeling abnormal |
Shortness of breath; Weakness; fatigue; loss of appetite; feeling in a daze; This is a spontaneous r...
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Shortness of breath; Weakness; fatigue; loss of appetite; feeling in a daze; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206), via unspecified route of administration in the right arm (at the age of 66-year-old) on 06Mar2021 at 14:00 as single dose for COVID-19 immunisation. Medical history included COVID (prior vaccination). It was reported that the patient had no allergies. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 07Mar2021, the patient experienced shortness of breath, weakness, fatigue, loss of appetite and feeling in a daze. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unspecified date. The patient was not tested for COVID post vaccination. The patient did not received treatment for events. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-06-03 | nervousness |
arm pain; some tiredness; I might have just been nervous; tightness in the back of her throat that l...
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arm pain; some tiredness; I might have just been nervous; tightness in the back of her throat that lasted for 30 minutes afterward; This is a spontaneous report received from a contactable consumer (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tightness in the back of her throat that lasted for 30 minutes afterward and described it as a feeling like she "had to clear my throat", arm pain, some tiredness, might have just been nervous. Seriousness was reported as no. It was reported that patient calling on behalf of her granddaughter, who is 22 y/o and has read about the Pfizer-Biontech Covid19 vaccine causing infertility. Is this true? Reported that she stated that she doesn't get vaccines very often, and might have just been nerves contributing to the tightness in her throat. Is this something she should mention before getting her second dose? Reminded caller to let vaccination site know of her previous experience, may want to monitor her longer after vaccination. The outcome of event (tightness in the back of her throat that lasted for 30 minutes afterward) was recovered on un unspecified date and outcome of events (arm pain, some tiredness, i might have just been nervous) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 66 | 2021-06-06 | delirium, disorientation |
Within 10mins or receiving the vaccine client experience light headedness and blurred vision. this q...
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Within 10mins or receiving the vaccine client experience light headedness and blurred vision. this quickly progressed to her having severe chills with violent trembling and a sudden severe headache. She with disoriented, BP elevated and experience acute delirium. She was assessed and treated in the ER with Hydralazine and IV fluids.
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| 66 | 2021-06-07 | sleep disorder, confusional state, memory impairment, insomnia, feeling abnormal |
On 3 May, 15 minutes after receiving my 1st Covid vaccine injection, I developed a deep, all-over bo...
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On 3 May, 15 minutes after receiving my 1st Covid vaccine injection, I developed a deep, all-over body tremor. (Batch: ER7449-024, date: 3/5/21, time: 10:49am - given). I do have a history of essential tremor, but the tremor was far worsened after receiving the vaccine. I didn?t report it to staff at the time, as it wasn?t anaphylaxis and I told them I was ?OK? when told my wait time of 20 minutes was up. I had had a similar tremor response to salbutamol during lung function test Dec 2020. It took hours to resolve after the lung function test, but it did eventually go, so I assumed the tremors after the vaccine would also be transitory. I noticed feeling spacey/dopey (brain fog) when I was walking to my car. I attributed it to a ?normal? vaccine response, as well as a headache later on that day. However, the tremor and brain-fog never dissipated, in fact, it got worse as the days went on. The brain-fog is probably now the most debilitating and distressing lingering effect. It feels like my head has been jostled all night - and the feeling is as if I have prescription glasses on that aren?t quite the right prescription. There was an immediate and noticeable increase in the tremor in my neck/head, a significant increase in the resting tremor in my right forearm, and a ?new? tremor in my core which feels like a loss spinal cord stability, which manifests in what feels like a wobbly oscillation of my core. It is transitory. I?ve felt unbalanced and ?fumbling?, but not ?dizzy?, and not tired. Within a few days I developed numbness on my palate (nasopalatine nerve?), and felt tightness through my neck and numbness through the left side of my face. This is still on going, though getting better. Within the first several days (prior to medication: propranolol and lorazepam) the tremors were so bad I had trouble sleeping , and felt like my legs were ?fizzing?. I?ve been trying to use as little medication as possible, but when I have a bad night?s sleep, the tremors and brain-fog are worse the next day. After several days, the tremors and brain-fog prompted me to contact Healthline, with them offering no solution, other than to get the next vaccine, which I have held off on, until I find some answers. I?ve reported my reaction to Health Covid Reaction website on 7 May 2021 - four days after Covid vaccination. Report Reference AEFI002846. Since I?m still having effects, I have recently sent additional information to The Centre for Adverse Reactions in Dunedin (attn: to Dr) to add to my initial report. The evening of 12 May I had an onset of severe pain in my right lung causing shortness of breath, and which felt like pleurisy. It took 4 days to resolve. I have no idea if this is related. I?ve had some pinpoint, very short-lived headaches, but they don?t last long. I?ve also felt my speech became somewhat forced/slurred, particularly the first few weeks. I?m struggling with short-term memory - doing dumb things, forgetting things, easily distracted - and sometimes feel somewhat ?confused?, struggle with the sequence of simple things, particularly if I?m having a bad day of brain-fog. The first week or so, I would get a loud buzzing in one ear which go within a minute or so. I do have a constant high-pitched tinnitus going on. For several weeks I felt as if something was moving inside my right ear canal. I stopped the medication on 3 May because I was feeling so foggy and couldn't attribute the feeling to the drugs or the reaction. While the tremor is reducing, I now see that I still have brain fog, tinnitus, and insomnia (with my legs feeling like they are 'fizzing' at night). I have windows of feeling OK, which gives me hope that this will eventually resolve. I?ve attempted to continue regular exercise, but never feeling quite 100%.
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| 66 | 2021-06-08 | amnesia |
experiencing headaches; Also short memory lapses; This is a spontaneous report from a contactable co...
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experiencing headaches; Also short memory lapses; This is a spontaneous report from a contactable consumer. A 66-year-old female (same age at vaccination) non-pregnant patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot: EN6200) via unspecified route of administration on 22Feb2021 at 02:30 PM as single dose in arm right for COVID-19 immunization. Medical history reported was allergies to Sulfa. Concomitant medications reported was citalopram hydrobromide (CITALOPRAM HBR, tablet) as 20 mg and Lisinopril Tablet as 2.5mg. Patient did not receive any other vaccine in four weeks. Patient didnt have covid prior vaccination nor tested post vaccination. On 07Mar2021, patient was experiencing headaches daily since Sunday and also short memory lapses. No treatment was received by patient in response to the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-06-10 | anxiety |
Vaccine-Related Anxiety (include misc. mental health); During her 15-minute waiting period after the...
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Vaccine-Related Anxiety (include misc. mental health); During her 15-minute waiting period after the injection, the patient began to experience light headedness; This is a spontaneous report from a non-contactable health care professional. A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration date: Not reported), via an unspecified route of administration on an unspecified date as a 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history included wheel chair user. The concomitant medications were not reported. On an unspecified date, the patient experienced vaccine-related anxiety (include misc. mental health) and during her 15-minute waiting period after the injection, the patient began to experience light headedness, also reported that She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Therapeutic measures were taken as a result of adverse events was as described in physical exam and with water. The outcome of all the events were recovered on an unspecified date. No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
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| 67 | 2021-01-03 | feeling abnormal, disorientation |
disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This i...
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disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included Atrial fibrillation/heart problems diagnosed prior to the vaccine, got the COVID virus on 18Nov2020, disoriented in Nov2020. Concomitant medications included her heart medication every day and vitamins, nothing out of the normal. Caller stated she had heart problems. The heart problems were diagnosed prior to the vaccine. Caller also stated that she got the COVID virus this year before the vaccine as well and she was off, of work for like a month. On 23Dec2020 she got the vaccine. Then on Thursday 24Dec2020 and Friday 25Dec2020 she had a reaction. She had passed out in the night, hit her head and cut herself, she was then disoriented for 1 full day. Caller stated that the last time she was disoriented like this was when she had the COVID Virus, because she had heart problems. Caller stated that she was fine now. Caller stated that she had been off, of work so much. The heart problem she had was Atrial Fibrillation. Caller clarified that she had the COVID virus this year in Nov2020, it was before thanksgiving, on 18Nov2020 she had the virus, then on 19Nov2020 she got tested and it was positive. She got the vaccine on the 23Dec2020 Wednesday then on 24Dec2020 at night she passed out and on 25Dec2020 she was disoriented all day. Investigation Assessment: No. On 24Dec2020 she was going to bathroom, and found herself on the floor, then the following day 25Dec2020 was when she was disoriented. She knew this because when she had the actual COVID virus previous in Nov2020 this happened previously. When queried outcome of being disoriented she stated that she still felt a little weird but if getting better very, very slow. The Second dose was schedule for 13Jan2021. Caller confirmed that she did have a Positive Test for Covid Previously. Her treatment at the time was in the Emergency Room, they gave her an Antibody infusion, she had to schedule it because it was actually a clinical trial. Caller was asked if she knew the name of covid test, she stated that she does not know, she only recalled that she opened her mouth and they test her that way. The outcome of the event "disoriented" was recovering, of the other events was unknown.
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| 67 | 2021-01-05 | feeling abnormal |
severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt l...
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severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt like 36 hours of bad flu
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| 67 | 2021-01-06 | insomnia |
100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unabl...
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100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unable to work today as scheduled due to these symptoms.
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| 67 | 2021-01-08 | feeling abnormal |
welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by mornin...
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welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by morning. Later in the morning, reappeared, mainly on back of thighs and rear end. took 2 tablets of 25mg Benadryl. took a n ap, and rash is gone again.
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| 67 | 2021-01-10 | anxiety |
5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, an...
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5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, and shakes that patient attributes to anxiety from possible reaction.
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| 67 | 2021-01-11 | feeling abnormal, anxiety |
Palpitations, HYPERtension, Anxiety Narrative: B/P=164/92, HR=115. Monitored for 30 minutes and HR...
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Palpitations, HYPERtension, Anxiety Narrative: B/P=164/92, HR=115. Monitored for 30 minutes and HR and B/P did not subside. After 30 mins B/P=157/89, HR=110. Pt continued to state, " I just do not feel right, just anxious feeling inside." Pt remained alert and oriented. Assistance was called from the ER and taken down for further monitoring.
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| 67 | 2021-01-11 | feeling abnormal |
phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report ...
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phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), intramuscular on the left arm on 04Jan2021 15:01 (she would say 15:01 because they told her to wait 20 minutes after receiving the vaccine and she left at 15:21) at SINGLE DOSE for COVID-19 immunization. The patient stated that she might be a little obese. There were no concomitant medications. When she got the vaccine on Monday (04Jan2021), she felt okay. The next day, it seemed like she had phlegm in her throat. She also had a horrible cough and headache. She don't know if it's the vaccine or what. It was mentioned that the phlegm in her throat was no longer horrible went away by the same day of 05Jan2021. The patient also stated that she took two acetaminophen (TYLENOL) for the headache and it went away last night (05Jan2021). However, she has the headache again by 06Jan2021. It was also mentioned that her dry cough that just won't go away, it's persisting. She can't cough, because people don't like that- they get uncomfortable. The patient mentioned that she didn't see any of these side effects on the paper she was given. It just made her uncomfortable, she didn't know what was going on with her body. Outcome of the events of productive cough and headache (initial occurrence) were recovered in 05Jan2021; recovering from dry cough; not recovered for headache (recurrence) while unknown for the remaining event.
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| 67 | 2021-01-11 | impaired work ability |
Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Ins...
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Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Instructed to stay home form work until symptoms improved.
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| 67 | 2021-01-14 | loss of personal independence in daily activities |
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel...
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received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
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| 67 | 2021-01-14 | mental impairment, feeling abnormal |
Vertigo started after lying down the same night of getting the vaccine. Vertigo continued every nig...
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Vertigo started after lying down the same night of getting the vaccine. Vertigo continued every night and was accompanied by nystamus upon waking each morning. Symptoms continued for the first several hours after awakening then would gradually get better and was much lighter during the day. Would return every night and next morning and this continued for the next 7 days. My head felt like it was in a fog and it seemed harder to think. It was also very sinus like. No nasal congestion, no post nasal drip, no cough, but my head felt thick and full. I had headaches which I never get. I took my blood pressure to be sure and it was normal. I took Claritin (without the D), Flonase alone and then also Dymista, did the Neti pot, and took Ibuprofen. Headache got better but still had the head fog. Today is post vaccine day 8 and I finally woke up this morning feeling better. Hope it lasts but I answered "Unknown" to Item 20 below because it's too soon to tell.
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| 67 | 2021-01-14 | sleep disorder, impaired work ability, feeling abnormal |
2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove p...
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2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove pt to work; brain fogginess, fatigue arriving home; pt did not eat for 2 days, lethargic; forced self to hydrate; missed work for 4 days. Large lesion roof of mouth l side to larger two front teeth, very painful, Veltrax PCP. Pt regained appetite as lesion went down in mouth. Lesion has resolved, all other symptoms have resolved.
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| 67 | 2021-01-20 | anxiety |
Pt identified as needing 30 min observation due to previous severe allergies. Pt reports she is feel...
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Pt identified as needing 30 min observation due to previous severe allergies. Pt reports she is feeling anxious: about the vaccines, long lines, and wait. RN spoke with her she stated that she experienced an allergic reaction to codeine in the past when she was in the hospital. Pt alert, oriented and calm. 3:20 pt reported she thought her throat was feeling itchy. RN called for assistance to observation room EMS called. Pt agreed to receive benadryl IM and 6L O2; and administered benadryl into left deltoid. EMS/FF arrived, pt declined transport. BP 168/104 taken 138/97, went home with daughter in law.
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| 67 | 2021-01-27 | feeling drunk |
Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she ...
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Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she received. Pt states she was Covid positive on 12/8/21 and received the Covid vaccine on 1/20/21. Later that day she reported feeling "woozy" and started to feel like she was "drunk" (pt states she has not had a drink since 2005). On 1/21/21 she felt "sick as a dog" and started "violently vomiting". She had a compazine suppository at home that she used which stopped the vomiting. She reports she remained extremely nauseated and fatigued for the next 24 hours. The nausea was only relieved when she would sleep or lie down flat. Pt states she slept the rest of the day on 1/21/21 to "about noon" on 1/22/21 and started to feel better during the late afternoon. She was able to eat dinner 1/22/21. Pt reports she still feels tired but that she is better on 1/23/21. Notified pt's PCP of events who followed up with pt with no further orders. Last note from PCP on 1/27/21. Spoke with pt 1/28/21 and pt states she remains without any further symptoms.
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| 67 | 2021-01-27 | nervousness |
10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burn...
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10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burning, tingling at rash site. Patient also felt thirsty (was then given water). Benadryl oral was given, but symptoms did not resolve and patient began to feel feverish and dizzy. Itch worsened and spread throughout body. Dexamethasone oral was given 15 minutes later. Itching started in mouth. EpiPen was administered intramuscularly to left vastus lateralis. Hypertension was noted post administration. Itching in mouth subsided, but patient began to feel shaky and still felt dizzy. Monitored for additional 20 minutes. After, patient was stable, walked out via wheelchair enroute home.
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| 67 | 2021-02-01 | loss of personal independence in daily activities |
2 hours after vaccination patient was lying in bed, when trying to leave bed she felt like she was p...
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2 hours after vaccination patient was lying in bed, when trying to leave bed she felt like she was pushed down multiple times, called 911 and was diagnosed with vertigo. Xanax and antivert did not help. Patient had to abandon stove while cooking due to symptoms and experienced house fire. Currently pursing care at mi ear institute.
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| 67 | 2021-02-02 | insomnia |
temp max 102.6 24 hr after vaccine. Low grade temps to 100.7 daily for 7 days. Worst symptom: severe...
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temp max 102.6 24 hr after vaccine. Low grade temps to 100.7 daily for 7 days. Worst symptom: severe insomnia days 3 thru 7.
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| 67 | 2021-02-04 | confusional state |
found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breat...
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found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.
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| 67 | 2021-02-04 | feeling abnormal |
Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous r...
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Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous report from a contactable consumer. This 67- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL3246), via intramuscular route of administration, on 19Jan2021 at 10:30AM (at the age of 67-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The medical history included: Blood pressure high, Diabetes, Hypothyroidism, High cholesterol, all from unspecified dates and ongoing. Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Concomitant medications included FLUTICASONE PROPIONATE (FLONASE) and montelukast sodium (SINGULAIR), both for Allergy. The patient received first dose BNT162B2 on 28Dec2021, (Lot: EJ1685, Expiry/NDC: Unknown), in right arm (Her arm hurt for about a week). Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Prior vaccination included: Pneumonia vaccine - States that her arms swelled up and turned red the day she got the vaccine. The next day she had chills, fever, and body aches; and she had a rash on her arm that started the day after the vaccine. Her doctor told her not to get the vaccine again. She does not have the Lot/NDC/Expiry to provide because it was many years ago. Prior vaccination: Flu shot - She swells up and turns red at injection site; she also gets fever, chills, and body aches with it as well. She does not have the Lot/NDC/Expiry to provide; she got it back in Oct2020 at the Hospital where she works. On 20Jan2021 03:00 AM, the patient experienced fever, aches, chills, and feels miserable. States that she reacts to the flu shot too, but nothing like this. Stated that all the events started in the early hours of the morning, around 3:00AM. She pushed herself to go to work, and it just got worse throughout the day. States that she has been alternating Tylenol and Ibuprofen since early this morning. The outcome of events fever, aches, chills, and feels miserable was not recovered, got worse through the day was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-02-04 | feeling drunk |
I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45...
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I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45. I was discharged Tuesday evening 2/2/21. Dr., my internist, agrees that what happened was not a vasovagal syncope (hospital?s diagnosis). My Experience: Within say 7 minutes of the injection I felt woozy, the wooziness intensified, I got intense pins and needles in my lower legs, fore arms and hands, and less so in my face. My speech became very slowed down, slurred and I had a lot of difficulty forming words. It was as if I was extremely drunk. After they called the paramedics, I was not able to get myself out of my car or walk. I lost motor coordination/control in hands and feet. I was cold, never felt faint, and had slightly evaluated blood pressure for me( normal is 110/64 paramedics got it at 152/94).
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| 67 | 2021-02-04 | panic attack |
Systemic: Other- patient said she felt short of breath, administered benadryl immediately precationa...
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Systemic: Other- patient said she felt short of breath, administered benadryl immediately precationary. Pt said she thought it might be panic attack afterwards and after breathing deeply & rest went back to work
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| 67 | 2021-02-06 | anxiety | Lightheaded but resolved after rest. Reported feeling anxious |
| 67 | 2021-02-07 | anxiety |
Patient had an increase in heart rate and anxiety post administration of vaccine. EMS was called on ...
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Patient had an increase in heart rate and anxiety post administration of vaccine. EMS was called on site.
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| 67 | 2021-02-07 | feeling abnormal |
Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizzi...
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Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizziness and headache. I then experienced tightness in the center of my chest and a generally mild shakiness. After waiting my 20 minute observation time, I recovered enough to drive home. However, mild mental fogginess, headache, tightness in chest and generally feeling unwell remain for 24 hours.
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| 67 | 2021-02-07 | feeling abnormal |
Pfizer covid 19 Bio Tech vaccine administered at 11:20 am. At 11:40 am I began feeling odd- fuzzy an...
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Pfizer covid 19 Bio Tech vaccine administered at 11:20 am. At 11:40 am I began feeling odd- fuzzy and light headed. Ears began to ring loudly. Lips became tingly and numb. Throat and tongue became tingly and numb. At 11:50 we had returned to clinic. 50 milligrams of Benadryl were administered. Blood pressure 120 over 60 (a bit high for me but anxiety accounts for that) . Pulse 60- normal for me. After being observed for one hour symptoms diminished and we left clinic. After 2 more hours all symptoms gone.
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| 67 | 2021-02-08 | insomnia |
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw...
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Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-02-08 | insomnia | Woke up with pain in right arm. Arm warm - could not sleep |
| 67 | 2021-02-09 | confusional state, abnormal dreams, excessive sleepiness, insomnia |
Onset with 1 hour of severe chills and trembling to the point of being unable to hold a glass of wat...
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Onset with 1 hour of severe chills and trembling to the point of being unable to hold a glass of water. Moderate to severe nausea lasting about 40 hours, onset about 10 am on 2/7/20. Extreme migraine headache starting about 2 pm on 2/7 and resolving around 9 am 2/10 intermittent but mostly present), vomiting onset around 2 pm 2/7 and continuing to 2/9 at 10 pm with dry heaves mostly, inability to keep down water 2/7 and 2/8, loss of appetite and no food from 2/6 at 6 pm to 2/ 9 at4 pm. Chills from 2/7 to 2/8 evening. Body pain from onset to throughout first day of symptoms. Extreme fatigue, significantly increased sleeping as possible. DIsorganized and intense dreaming for nights 2/8 and 2/9. Difficulty sleeping due to pain and nausea. Treatment: Zophran for nausea, mildly effective, didn't really stop nausea or vomiting. Tylenol for migraine, no effect. Outcome: Symptoms except for fatigue began to slowly resolve on 2/9 late morning. Better on 2/10, eating and drinking some but not back to normal. Fatigue moderate but better. Considered presenting to ER for IV fluids and medications, but consulted with physician and decided to wait to see if symptoms decrease by 2/10.
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| 67 | 2021-02-10 | confusional state |
Four day incapacitation;followed by 3 days of lessening symptoms of fever, bone and body ache, weakn...
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Four day incapacitation;followed by 3 days of lessening symptoms of fever, bone and body ache, weakness , headache, mental confusion, diahrea and dehydration
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| 67 | 2021-02-10 | restlessness, nervousness |
The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I we...
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The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I went to bed. I started having generalized pain, all my muscles became achy and my R arm was so sore I could not move it. About 1 am the next morning, I became nauseated and retching. I stared sweating and chilling, my body was shaking so bad I could not hold my thermometer. That lasted possibly 5 minutes, fever 100.8. Episodes of sweating alternating with cold chills occurred the remainder of the night. Exhaustion set in and I could not get out of bed. I was on bedrest all morning and I began to feel better around 4-5pm the next day.
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| 67 | 2021-02-11 | delirium | Diarrhea, vomiting, rash, mild hives, chills, episode of delirium |
| 67 | 2021-02-12 | excessive sleepiness |
Vertigo when I awoke on 2.12.21. The smell of roasting chicken prompted GI symptoms like food poison...
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Vertigo when I awoke on 2.12.21. The smell of roasting chicken prompted GI symptoms like food poisoning: intense gastrointestinal cramps, soft stools, then vomiting. I slept for many hours, ate a little so I could take my antibiotic, slept, ate and took my second antibiotic, slept, awoke at 1 am with an intense headache, so ate 1/2 banana, took 2 Advil, then slept for 8 hours. I awoke feeling spent, but healthy again! Still experiencing vertigo from time to time.
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| 67 | 2021-02-14 | anxiety |
About 10 minutes after vaccine administered patient started experiencing a racing heart sensation. D...
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About 10 minutes after vaccine administered patient started experiencing a racing heart sensation. Described slight shortness of breath. Admitted to history of anxiety, has home xanax. Has not taken any today. Patients HR was at 110 initially after monitoring for about 15 minutes it stabilized to mid 70s. Patient has remained in the mid 70s for 20 minutes without any interventions. Complete resolution of symptoms.
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| 67 | 2021-02-14 | feeling abnormal |
On 2/5/21, started with headache, brain fog which seem to be getting worse rather than better. This...
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On 2/5/21, started with headache, brain fog which seem to be getting worse rather than better. This still has continued since it's onset. Has taken Advil. Called her provider and they asked her to go to V-safe. Is scheduled to receive the 2nd vaccine on Thursday, 2/18/21.
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| 67 | 2021-02-15 | panic reaction |
Client c/of nausea and dizziness. states that she hand's had anything to eat since am. client star...
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Client c/of nausea and dizziness. states that she hand's had anything to eat since am. client started having symptom after getting out of car to walk her dog. Pt voice that she suffers from panic disorder and was having an episode. Pt assessed, vital signs are as follows: BP 130/84, HR 80, O2 97%. Client cleared to go home after stating she felt better.
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| 67 | 2021-02-16 | amnesia, disorientation, confusional state |
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyano...
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Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave a breathing tx, O2 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to MC. Diagnosed with transient global amenesia and hypercapnia. Client was transported to MC for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o severe H/A, nausea, dizziness, myoclonic seizures. Severe h/a which lasted 4 days. Still experiences mild memory loss, confusion, and h/a are becoming less severe. Client states that sensory processing is slowed
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| 67 | 2021-02-17 | anxiety |
Patient received first dose of Pzifer Vaccine. Approximately 20 minutes later developed tightness t...
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Patient received first dose of Pzifer Vaccine. Approximately 20 minutes later developed tightness to her posterior neck and shoulders. Encouraged to remain for full 30 minutes, patient continued to report these symptoms. Patient evaluated by RN Observers, denies shortness of breath, mouth/tongue swelling, palpitations, itching, rash. Patient given 25mg PO Benadryl from Vaccine Clinic RN. Patient reported she maybe was a little light headed and anxious so she laid down. About 10 minutes after she reported feeling some better and wanted to go home. Patient counseled by RN, Resource Nurse on signs and symptoms to watch for and when she should call 9-1-1 if symptoms worsen.
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| 67 | 2021-02-17 | sleep disorder |
Serious chills at night of injection, causing me to wake up and take a hot bath; intense headache la...
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Serious chills at night of injection, causing me to wake up and take a hot bath; intense headache lasting from night around 6pm until about 4pm the next day, finally too 100mg Tylenol at 1pm the next day, which helped; aching in muscles throughout the night and morning of the next day, including injection site; cramping in extremities on night of injection (hot bath solved this).
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| 67 | 2021-02-18 | disturbance in attention | Blurred vision and inability to focus right after the vaccine. Still experiencing blurred vision. |
| 67 | 2021-02-21 | incoherent | 103 fever, difficulty breathing, chest cough, not coherent |
| 67 | 2021-02-21 | insomnia, disturbance in attention | Full body aches Insomnia Headache Difficulty concentrating Temp low |
| 67 | 2021-02-23 | anxiety | Patient complains of increase heart ate (on her watch) and feeling very anxious. BP 155/75. HR 98 |
| 67 | 2021-02-25 | anxiety |
Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patien...
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Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand All Collapse All 2/24/2021 Patient Date: 2/24/2021 Subjective is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes none. She does not take any medications but is on Vyvanse.none. She denies any medial hx. Not on any medications. She did drink a protein shake this am. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, chest tightness and itching of skin (to R shoulder/injection site area) Patient denies fever, malaise/fatigue, nasal sores, sneezing, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1024 02/24/21 1029 BP: (!) 180/73 (!) 150/90 Pulse: 71 SpO2: 97% Blood Sugar 108 collected at 1050 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Findings: No rash. Comments: Injection site and R arm without erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) PT monitored and improving. Pt ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Pt aware of what to monitor and when to go to ED. Pt voiced understanding and appreciated. Pt able to ambulate out of the facility with ease. APRN Electronically Signed 2/24/2021 12:27 PM
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| 67 | 2021-02-25 | nightmare |
I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My ar...
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I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My arm was just little uncomfortable; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; I am getting nightmares, it's like I am struggling; Fibromyalgia/never have 'flare-up' this bad; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1283; expiration date: unknown) at 67-year-old age of vaccination via an unspecified route of administration in the left arm on 21Jan2021 at a single dose for covid-19 immunization. Medical history included fibromyalgia. The patient's concomitant medications were not reported. The patient reported that she got her vaccine on a 21Jan2021 (Thursday) and on Friday (22Jan2021), her arm was just little uncomfortable but its fine. On Saturday by 4 o' clock (23Jan2021), she really hurt so bad all over and with headaches. By Sunday (24Jan2021), it went down a little bit and it was going away but last night (unspecified date in 2021), it hit again it just waking her up and she was getting nightmares, it's like she was struggling. She mentioned that she has a history of Fibromyalgia, but she never has 'flare-up' this bad on unspecified date in 2021. It was reported that the patient with fibromyalgia was given Pfizer Covid-19 Vaccine. She further stated that she hurt all over like right leg, left leg, upper body. The patient received treatment of acetaminophen (TYLENOL). The adverse events did not require an emergency room/ physician office. She mentioned that she has read all literature, it says you can get side effects, but this isn't normal. The outcome of the events limb discomfort, pain and headache were recovering while the outcome of the other events was unknown.
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| 67 | 2021-02-26 | anxiety | Chest pressure and anxiety- monitored and cleared by EMS |
| 67 | 2021-02-28 | insomnia |
Extreme hive spots beginning at scalp and spreading to knees between 6-12 midnight. Area between hiv...
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Extreme hive spots beginning at scalp and spreading to knees between 6-12 midnight. Area between hive welts filling in with rash or redness. Following day, began to spread again around 5 PM - went to ER - prednisone and benedryl administered. Hives intensified over night disallowing sleep. Next two days hives continued to welt up especially late in the day (having spread to face and neck). Sunday night seeing the redness between welts start to subside in some areas completely. Itching continues into Monday morning but not as intense.
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| 67 | 2021-02-28 | mental impairment, confusional state, feeling abnormal, disturbance in attention |
not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision wa...
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not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision was off; foggy; confused; coughing; felt severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped; severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher you know more towards my throat; rapid heart rate, 100bpm and 102bpm and lasted for couple of days.; my head was more clear but still had some pressure and woozy; Trouble concentrating; ALT High; Test: Cholesterol; Result: Little High/Cholesterol 207 was high; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9269), via an unspecified route of administration on 07Feb2021 (at the age of 67-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Medical history included ongoing asthma, type 2 diabetes mellitus, seasonal allergy (told to take Zyrtec for seasonal allergies prophylactically). Facility in which the vaccine was received was a clinic at a high school through the local hospital. Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB), glipizide (GLIPIZIDE). On 07Feb2021, the patient received the first dose and while walking to the observation area (about two minute after receiving the vaccine) the patient experienced very very intense headache, felt an ungodly pressure in my head, vision was off, and trouble concentrating. When she sat down got real foggy, confused and was not thinking straight, was coughing and experienced severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped. Patient began taking deep breath. It went back over to left side of my chest and the tightness (stayed in my left chest for probably 3 days but not to the same degree). The fogginess and the intense pressure in my head, it was bad to the point she thought she would not be able to drive home, waiting for 30 minutes, and because she was not thinking clearly she didn't even ask anybody for help. When she got to the car she waited 15 minutes more before driving home. Patient stayed like this for 2 days. When she reached home, she experienced a rapid heart rate, 100bpm and 102bpm and lasted for couple of days. Each day got gradually better, her head was clearer but still had some pressure and woozy. The patient did visit the physician, he did an EKG and other test. The doctor did not think what I had was an anaphylaxis reaction. Physician recommended she make sure to take her inhalers, for asthma and told me to take Zyrtec (for seasonal allergies) ahead of time. Consumer inquired if she should receive the second dose. The patient underwent lab tests and procedures which included blood cholesterol: little high 207 on Feb2021, blood thyroid stimulating hormone: normal on Feb2021, electrocardiogram: normal on Feb2021, full blood count: normal on Feb2021, hemoglobin: 6.9 on Feb2021, heart rate: 100 bpm on Feb2021, heart rate: 102 bpm on Feb2021, metabolic function test: Alt high on Feb2021. No treatment was given for the events. The clinical outcome of the events not thinking straight, pressure in my head, foggy, confused, coughing, tightness in the left side of my chest , it then moved to the center of my chest then moved up towards throat, rapid heart rate, Woozy, intense headache, vision was off and trouble concentrating was recovering while ALT High, and Cholesterol; Result: Little High was unknown.
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| 67 | 2021-02-28 | sleep disorder |
Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with han...
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Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with hand and shoulder movement limitation. Last two days chest discomfort with some difficulty in breathing. Last night first time developed severe skull pain at posterior area. Symptoms mainly during night time and unable to sleep due to the intensity. Treatment: Voltaren Gel 1%, Generic Mobic 7.5 mg and Sombra Warm Therapy Natural Pain Reliving Gel, Acetaminophen 500mg. Most of the symptoms have been for the last three weeks.
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| 67 | 2021-03-01 | disturbance in attention |
Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder cap...
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Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder capsule and right ankle, 101 degree fever lasting 6 hours Day 2: chills, exhaustion/weakness, inability to concentrate, lack of appetite Day 3 &4: waves of muscle aches and exhaustion
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| 67 | 2021-03-02 | feeling abnormal |
Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the...
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Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
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| 67 | 2021-03-02 | insomnia |
Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I cou...
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Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 67 | 2021-03-03 | feeling abnormal |
low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she h...
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low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she had been run over by a truck; really bad headache with aches all over/head has been hurting really bad; cough; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 67-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), cholesterol (blood cholesterol) and several bypass surgeries. She mentioned that she was pretty healthy for her age. Family history included father died of heart disease and her sister has heart disease. Concomitant medication included unspecified blood pressure and cholesterol medication. The patient has no previous vaccination within 4 weeks and did have other vaccines given on the same day. The patient reported that she did not feel bad on the first day, but she started getting a cough on Saturday night (30Jan2021) and on Sunday (31Jan2021), she started getting a really bad headache with aches all over. This morning (02Feb2021), she is running a low-grade fever (99.4F). She added that now she was sick, she has a low-grade fever, chills, is hurting all over, all the things on the list. She inquired if these are common side effects of the vaccine and was asking if she should get tested to see if she's diagnosed with COVID-19. She inquired will her getting the shot effect the results of the COVID test, would she test positive for COVID now that she's had the shot. It is confirmed she has not tested positive for COVID. She did have 2 tests previously in Dec2020 before and after traveling. She further explained that she didn't feel bad until Saturday night and that is when she started with nagging cough. The aching all over started on Sunday (31Jan2021), feeling like she had been run over by a truck. She hadn't had a fever until this morning (02Feb2021), she woke up with a low-grade temperature of 99.4. She has been taking acetaminophen (TYLENOL) that helps. The call also notes later in the call that her head has been hurting really bad and this started yesterday (01Feb2021 [also reported as 31Jan2021]). It is remarked that she will probably be tested if the vaccine doesn't affect the results. The adverse events did not require emergency room or physician office. The outcome of the events was not recovered.
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| 67 | 2021-03-03 | nervousness |
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (t...
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Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye), during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky. I waited 20 minutes and went to the restroom and had diarrhea (very rare for me). I went to my car and looked in the mirror and my face was bright red and the whites of my eyes were red and my eyes were glassy. I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes. Right after I took the Benadryl my throat felt itchy (not sore - itchy). My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home. My bp is normally about 106/60. I was really tired at home for the rest of the day so went to be early. The next day I felt fine and my arm was only slightly sore. The doctor at the immunization clinic told me not to get the 2nd shot. I called my GP, and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine. I did not have any difficulty breathing. I don 't know if the redness on my face went down my neck to my chest. I didn't look. I did not have a fever.
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| 67 | 2021-03-06 | sleep disorder |
Within 2 days got horrible Tinnitus in left ear. Less in right. Can not sleep and during day also he...
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Within 2 days got horrible Tinnitus in left ear. Less in right. Can not sleep and during day also hear high pitched noise all the time. Has not stopped since day after injection and worried it will last forever. Very distressing. No where is this listed as side effect and yet on internet people are complaining about it. This should be brought to public's attention so a correct decision can be made on whether to go ahead for vaccine. I will not be getting the second dose for fear this will get even worse. Ruining my days and nights.
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| 67 | 2021-03-07 | feeling abnormal |
c/o feeling "foggy" and left hand tinging and numbness 30 minutes after dose(1040 am).. Pt took own...
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c/o feeling "foggy" and left hand tinging and numbness 30 minutes after dose(1040 am).. Pt took own Benadryl tablets(2) BP 189/90, HR 55 Speech clear, A & O x 4. . 15 minutes later (1055), c/o "tongue swelling" and took another Benadryl tablet. No swelling observed, speech clear, no airway impairment. BP 170/90, HR 54, oxygen saturation 98%. 1110, c/o left thumb feeling "numb". 1120, tongue swelling sensation resolved. 1130, patient ambulated with RN, took additional Benadryl tablet. Stated hand numbness was resolving. "I'm going to be okay". 1155, pt escorted to vehicle.
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| 67 | 2021-03-07 | feeling abnormal |
Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/...
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Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is "sulfa dioxide" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to "sulfanized compounds". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from "most people having more reaction on the second dose of the vaccine" and also from what Pfizer second line told her "the first dose primes the system while the second dose strengthens the system". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-07 | sleep disorder |
I am still experiencing excessive itching at the site of the injection and this is one month after t...
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I am still experiencing excessive itching at the site of the injection and this is one month after the 2nd dose. It is usually at night and wakes me up. The only relief that seems to work is an ice pack. Topical cortisone does not help. It seems to be happening less and less but I thought I should report it. There is no rash or swelling. I had a similar reaction to The Shingrix Vaccine after the 2nd dose. It lasted six months and was worse! I would like to know what might be causing this. I had no problem with the Flu Shot.
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| 67 | 2021-03-08 | anxiety |
Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to...
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Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to the floor and her blood pressure was taken, at 104/85. She was sweaty and clammy. Patient stated that she was anxious about the vaccine and something like this had happened before. After laying on the floor she felt better and soon after sat up in her chair. Her blood pressure was taken again and rose to 133/66. She was observed in the waiting area and started feeling better after 15 minutes.
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| 67 | 2021-03-08 | feeling abnormal, sleep disorder |
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cra...
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Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea —no appetite. Nasal congestion and mild cough. Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm. Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
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| 67 | 2021-03-08 | sleep disorder |
No symptoms until 8:30 PM on fifth night after injection. Headache, unable to sleep fifth night aft...
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No symptoms until 8:30 PM on fifth night after injection. Headache, unable to sleep fifth night after injection. Dizziness beginning 9:00 AM and lasting all day sixth day after injection; Nausea and shortness of breath beginning 7:00 PM on sixth after injection; able to sleep sixth night after injection. Fatigue and shortness of breath beginning 8:00 AM and lasting all day seventh day after injection until 8:00 AM eight day after injection. Side effects were moderate, subsided on their own.
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| 67 | 2021-03-09 | sleep disorder |
Violent entire body chills approximately 12 hrs after vaccine. Chills lasted an hour with 3 blanket...
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Violent entire body chills approximately 12 hrs after vaccine. Chills lasted an hour with 3 blankets and heating pad. Then switched to fever for next 8 hours. Fever recorded 102 the only time I checked. Nausea, body aches, plugged nose making it slightly difficult to breathe, headache, and exhaustion. Unable to sleep through the night due to fever, aches, and breathIng discomfort. Slept off and on all following day. Able to eat minimally at dinner next day. Strong taste of food, ie chicken soup seemed way strong. Third day tired but appetite slightly returning and other side effects seem subsided.
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| 67 | 2021-03-10 | feeling abnormal |
Before i arrived at the waiting area, which had no attendant on duty though intake personnel were wi...
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Before i arrived at the waiting area, which had no attendant on duty though intake personnel were within sight range, i had an extreme pressure sensation on the right side of my head. I lessened the effect by holding my nostrils and blowing when reminded to do so by my husband when i returned to the car after 15 minutes. Sensations that reminded of bugs crawling beneath my scalp began shortly thereafter, and continue to a lesser degree to this day. I had lethargy, fatigue and brain fog.until Wednesday. My right eye remains challenged as i do have an ongoing eyelid issue for the last 8 years. No arm soreness.
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| 67 | 2021-03-11 | anxiety | Chest tightness,air hungry, and anxious. |
| 67 | 2021-03-13 | insomnia |
ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above ...
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ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above 99 degrees) joint aches, swollen lymph nodes, sweats, scratchy throat, red irritated eyes, bowel cramps and nausea
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| 67 | 2021-03-14 | disturbance in attention |
nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontan...
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nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
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| 67 | 2021-03-14 | disturbance in attention |
Headaches & dizziness a few times on 1st & 2nd days. Soaked bed from sweating all night on 1st & 2n...
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Headaches & dizziness a few times on 1st & 2nd days. Soaked bed from sweating all night on 1st & 2nd days. Off-balance and dizziness on & off since 3-2-21. Blurry vision/ can't focus, which bothers me more than the other adverse events.
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| 67 | 2021-03-15 | feeling abnormal |
Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and i...
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Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.
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| 67 | 2021-03-15 | panic attack | Patient had slight panic attack post vaccine. Requested blood glucose check. BS 198 |
| 67 | 2021-03-16 | delirium |
I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the ...
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I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the pharmacist contacted me telling me I had only received a saline solution and would need to get vaccinated again. I inquired how they knew this and received sparse information saying they couldn't tell me ... privacy etc. Then on March 10th I went to another one of their locations and received the first vaccine of Moderna ... I have been super sick since then.. I have had fever, delirium, cognitive impairment ( forget vocabulary MID sentence) severe covid arm, ( worse than the images on line) pain in my left hand, stiffness in my left fingers ( what I assume arthritis might be like) I WANT TO KNOW what WAS IN THE FIRST PFIZER INJECTION: I AM DEMANDING... to find out what was in the first shot, why it was reported to me 4 days later, How the facility knew it was only saline... WAS it TRULY ONLY SALINE or have I been injected with two different doses of vaccines within a 9 day period? I really need to know what it going on.
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| 67 | 2021-03-18 | mental status changes, thinking abnormal, nightmare, abnormal behaviour, mental impairment |
Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her a...
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Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her appetite; heard in the background stating the COVID-19 Vaccine screwed up her mind; Headache; Eyes hurt/Her eyes felt like they were going to pop out; Feels tired and weak; Feels tired and weak; can't think straight; pain in head and stomach; change of mood; altered mental status and nightmares; altered mental status and nightmares; she is so mean to everybody / not acting normal; her eyes felt like they were going to pop out; Suicidal thoughts/thinking of committing suicide; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL267, expiry date 31May2021) via an unspecified route of administration, at the age of 67-year-old, on 24Feb2021, as SINGLE DOSE (0.3mi as reported) for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and ongoing allergy to penicillin. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265, expiry date 31May2021) via an unspecified route of administration, on 03Feb2021, single dose for covid-19 immunisation wherein the patient had to got to Emergency room and it was found that her magnesium and potassium were low. The patient had a super bad reaction to the Pfizer vaccine. Patient's mind has not been normal ever since and she is so mean to everybody. The patient was fine until she got the vaccine. The reporter has had the ambulance and police up there to try and help but the caller wouldn't go out to the hospital. The patient had a normal mind before she got the shot. The patient has a bad headache that will not go away (8 days) and her eyes are hurting really bad/eye pain/ eyes hurt. She feels so tired and weak. The second COVID-19 Vaccine messed the patient up. She had the same symptoms for both first and second dose (unspecified symptoms), but the second dose has really messed up her mind. Patient probably won't have a mind. It was reported that the patient's mind was alright, but the second COVID-19 Vaccine did her in. Now patient is saying she won't get her mind back. It has messed up her mind. Clarified when caller states it messed up her mind, he is referring to the patient being mean. Stated patient did have a headache, but wasn't hateful. Stated patient's mind is so bad, she is just mean. If patient doesn't get help soon she is going to tell herself good night. Patient stated in background "If I don't get my mind back I'm going to end up killing myself because he made me." At 11PM last Wednesday (24Feb2021), patient starting losing her mind. Confirmed with caller that patient is currently having suicidal thoughts. Patient used to be a real nice lady and blames this on the COVID-19 Vaccine. Patient is afraid she is not going to get her mind back. Advised caller to seek emergent medical attention for the patient. Patient is against everybody now because of the crazy COVID-19 Vaccine. Patient heard in the background stating the COVID-19 Vaccine screwed up her mind. Caller stated patient is quite upset with everybody. Patient is not acting normal. Patient doesn't think her mind will ever get straightened. The medicine was too much for her body. After getting the second dose, the patient lost her mind, she's lost her appetite/ No appetite and went 32 hours without eating, can't think straight, altered state of mental, mental fog, pain in head and stomach, change of mood, nightmares, her eyes felt like they were going to pop out. Her doctor said it was probably an overdose. The patient was not like this prior to second dose. Outcome of the event was unknown. The reporter believes her mental fog is due to second dose of vaccine.
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| 67 | 2021-03-19 | feeling abnormal |
I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an ...
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I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an hour of the shot and became quite fatigued a couple hours later. Approximately 8 hours after injection I began having severe chills with teeth chattering and muscle cramps and aches. which lasted for three exhausting hours. Then suddenly I had a fever of 101 degrees and body aches and nausea with extreme fatigue until 4:00 PM the next day. The fatigue and brain fog continued until 48 hours or so after the shot. My arm did not hurt at all by the way. Nurse had me pull my arm down in an exaggerated way as she gave me the shot and it seems to have helped.
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| 67 | 2021-03-20 | feeling abnormal, excessive sleepiness |
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradu...
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Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
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| 67 | 2021-03-20 | sleep disorder |
-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wr...
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-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wrap around my diaphragm up to my collar bone, as if my breath was being taken away. I yelped out but the three people in the car with me did not here me. I remained calm took a deep breath- feeling went away. - Had vaccine on Saturday. Woke up in the night on Sunday night, feeling like my tongue was swelling and my throat was closing up. I took 1/2 Benadryl and used Albuterol enhaler. Temp was 99.8 (my average at home is 96.5)Fell back asleep. Woke up the next day and was fine. - other symptoms were tiredness, headaches, achy joints, which went away fairly as quickly. -since the vaccine I have had a bad outbreak of do
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| 67 | 2021-03-21 | anxiety |
Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling...
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Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling. She denied any history of diabetes. Patient stated that she has many severe allergies (did not verbalize to what specifically even when asked) and even carries her own epi pen. She acknowledged that this did not feel like an allergic reaction and more like symptoms of anxiety. Patient refused EMS and stated she wanted to wait to see if she could calm down. Second RN and Pharmacist were called for assistance. Pulse ox was placed on patient and O2 Sats ranged from 94-97%, HR 90's. Patient stated she had history of HTN and asked for her BP to be taken d/t her headache. BP was 128/85. After about 20 minutes of close monitoring, patient stated that she was starting to feel better and trembling decreased. Patient remained in observation area for 30 more minutes and left in stable condition after all symptoms had subsided.
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| 67 | 2021-03-21 | depression, panic attack | Terrible panic attacks,depression,faint,lightheaded |
| 67 | 2021-03-21 | excessive sleepiness, loss of personal independence in daily activities |
1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically...
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1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically, now daily. 3. Back pain near kidney developed a week after vaccine. 4. Thirsty and for 3 days unquenchable thirst. 5. Had spurts of joint pain all over for several days. Did not have these symptoms with 1st vaccine, this has been progressing for 2 weeks, as of tomorrow, and got worse as time passed. I am very active and healthy and this has certainly impacted my routine. I still work. Visit to Dr. about back pain resulted in negative test and Dr. blamed it on vaccine.
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| 67 | 2021-03-21 | sensation of foreign body |
Woke up in middle of night with pain at the collar bone (same side as injection ) It was swollen and...
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Woke up in middle of night with pain at the collar bone (same side as injection ) It was swollen and felt a lump the size of a large marble . Went to the emergency room that morning. Seen by nurse practitioner and diagnosed with Inflammation of the lymph nodes. Could not confirm it was related to the vaccine. The next morning on 03/13 woke up with large very red patchy rash that covered the shoulder area and down to the elbow. Again same side as the injection. Took Benadryl for 5 days
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| 67 | 2021-03-22 | feeling abnormal |
I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269...
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I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269) on 2/18/21. That evening she reported not feeling "right". Over the next two days after receiving the vaccine on Thursday she reported to family that she didnt feel well. She had no fever but muscle aches, an earache and sore throat (this was on Friday and Saturday). On Sunday her breathing became a bit labored. She still had previous symptoms reported and labored breathing -- she stated she thought she would have to go to the Dr the next day (Monday, Feb 22, 201) if she did not feel better. Sometime in the night of Feb 21st and Feb 22nd my mom passed away. My mom had many health problems. Heart disease, diabetic, she was on dialysis and had sleep apnea. However, she definitely seemed to be having some difficulty with the affects of the first vaccine. Please let her life be counted.
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| 67 | 2021-03-22 | feeling abnormal | Fever, aches pains, rash brain fog sleep |
| 67 | 2021-03-22 | excessive sleepiness |
Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Le...
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Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Left armpit swollen & itchy. Dull headache all day. All joints in entire body ached entire day. Tired feeling all day and night. Slept 4-6:30 pm and 9:30 pm to 1:30 am the following morning. Temperature down to 99.2 degrees at 1:30 am. Difficulty raising left arm more than 45 degrees.
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| 67 | 2021-03-23 | anxiety |
racing heart around 6:00 pm, lasted a few minutes. have had anxiety over it. I went to my doctor. ...
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racing heart around 6:00 pm, lasted a few minutes. have had anxiety over it. I went to my doctor. all my vital signs were good. could be anxiety caused it?
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| 67 | 2021-03-25 | anxiety |
Pt arrived at observation area. at around 8:45 am. At 08:53, the patient stated 'I feel dizzy" Pati...
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Pt arrived at observation area. at around 8:45 am. At 08:53, the patient stated 'I feel dizzy" Patient lower extremities elevated on a chair. V/S obtained BP 152/88, P-61, SaO2 100%. Pt denied anu other concerns but stated B/P usually 120/70.. POC glucose obtained by EMT. Result 103. Apple juise and Graham crackers given to patient. Pt. stated she has eaten this am but was thirsty. 0905- Pt remains stable with c/o dizziness at same level. VS 151/86, P-60 Sats 100%. Pt. given small bottle of water. Pt. stated she had been under moderate stress due to a recent release from employer. She denied any chronic conditions other than HTN. 09:20- Pt. states she is 'still dizzy' this is what happened last time" EMY and writer continue to monitor Monitoring patient at present.. VS improving. Pt states level of dizziness unchanged. BLE remain elevated on chair. Stated she 'felt a headache coming on'. VS 140/81, P-62, Sats 100% 09:46- Recheck of vital signs- 145/87, P-61, Sats 100% Pt stats she is starting to 'feel better' juice pak, small bottle of water and @) graham crackers consumed. 10:00- Pt has felt 'well' and wants to leaved. VS stable. B/P 147/68, P-61, Sats 100%. Writer walked with pt. to elevator. Tolerated well. Denies any issue of dizziness.. Pt. discharge to home. All questions answered. Impression- vertigo and elevated blood pressure related to anxiety. Pt advised to follow up with her MD. Also advised to call 911 if symptoms return. Pt verbalized understanding of all information.
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| 67 | 2021-03-25 | insomnia |
Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am...
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Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am with N&V, chills, fatigue & later in the day diarrhea. Slept off & on throughout the day, drank nothing but Gatorade, Gingerale & water. That night had a temp of 100.8 took Tylenol. Day 4 fever broke able to stomach dry toast & later Chicken Noodle soup but still continued with diarrhea. Day 5 starting to feel a little better, tried to eat normally, but later continued to have diarrhea. From Day 6 to today (Day 12) I still continue to have some nausea & diarrhea & fatigue.
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| 67 | 2021-03-25 | insomnia | Chills Headache Muscle and Joint pain Trouble sleeping |
| 67 | 2021-03-26 | poor quality sleep | wakefulness, jitters, achy |
| 67 | 2021-03-27 | excessive sleepiness, feeling abnormal | I was fine for a few days then got really sick on 5 th day & have felt bad since then. |
| 67 | 2021-03-28 | abnormal dreams |
Right shoulder blade started hurting immediately, told administer. Later felt weak, clammy, nauseat...
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Right shoulder blade started hurting immediately, told administer. Later felt weak, clammy, nauseated, all over dizzy/shaky. Napped fitfully, sweat profusely (sour smelling sweat), weird dreams. After about 4 hours, woke, feeling better, but had not appetite to eat dinner. Started feeling all of the same again around 10 pm, so went to bed. Went through the same most of the night , woke around 7 am , feeling better, but seriously drained. Right shoulder blade still hurts. Still pretty drained, two days later.
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| 67 | 2021-03-30 | anxiety, feeling abnormal |
pt states she started feeling very bad and everything hurt the day after getting the vax. She has a...
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pt states she started feeling very bad and everything hurt the day after getting the vax. She has a lot of hair loss. She had to stay in the bed for the next couple of days because she had fatigue and body aches. 5 weeks after taking the vax she has swollen lymph nodes in both arm pits and he developed sore knots under the skin on the outside of her thighs. Her BP has become uncontrollable. She was on 10mg of bp medicine and then it was upped to 20 mg. About 7 days ago a diuretic and her BP is still very high. on 3/20/2021 it was 180/89. she checked it again a couple of hours later and it was 165/92. She has had symptoms of GERD since 3/22/2021. Blood work she had on 3/18/21 shows way too much carbon monoxide in her CO2. Her anxiety has increased since she was vaccinated. She has an appt w/ her PCP on 4/9/21. She is very concerned that she is going to die from taking this vax.
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| 67 | 2021-03-30 | confusional state, disorientation, feeling abnormal, excessive sleepiness |
passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she ...
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passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she was dehydrated in hospital and did not eat a thing; stayed dizzy; confused; She had felt disoriented; foggy; it was like the flu shot; sleeping a lot; her vision would get very narrow; thumb pink; erratic body temperature; horrible headache; bodyaches; dry heaves; slight fever/ body temperature 104.4; injection site sore; lymph nodes swollen; This is a spontaneous report from a contactable consumer (patient). The 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer - stage 2 from Jan2008; 29Jan2008 surgery, breast cancer. First surgery for breast cancer removal and lymph node removal, then the cancer went around the first and second lymph nodes so they had to go back in because they had to take out a bunch more and she had to give them permission to take out more lymph nodes. Concomitant medication(s) included ongoing simvastatin for High cholesterol; ongoing bifidobacterium bifidum, bifidobacterium longum, lactobacillus gasseri (PHILLIPS COLON HEALTH) she has high pain tolerance, had stomach cramp did not know what it was and one a day vitamin. The patient previously took bnt162b2 (BNT162B2), dose 1 intramuscular administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization and experienced Injection site sore. The patient experienced passing out on 28Feb2021, injection site sore, lymph nodes swollen on 04Feb2021, thumb pink on 26Feb2021, erratic body temperature, horrible headache, bodyaches, dry heaves on 05Feb2021, she was 155 lbs before when she was in the hospital - and now 160 lbs on an unspecified date. The patient was hospitalized for passing out from 01Mar2021 to 02Mar2021. The event passing out leaf to emergency room visit. The patient lab tests and procedures which included cat scan/ cat scan groin area with contrast: normal; EKG: normal; blood workup: normal; Blood culture:normal, all on 01Mar2021; cat scan head and neck with contrast: normal and cat scan head and neck without contrast:normal on 02Mar2021. The outcome of the event thumb pink was recovering, erratic body temperature was not recovered, horrible headache, bodyaches, dry heaves recovered on 26Feb2021, and was unknown for the rest events. Reported as: Caller states that on 04Feb2021 she received her 2nd vaccine at around 3:30 pm, and then around 10 pm she had injection site soreness. The morning after the second injection around 4 am, she had site on her arm soreness, erratic body temperature with slight fever, horrible headache, bodyaches, and dry heaves. Her lymph nodes also swelled up again. Caller clarifies that this also happened after her first injection of the Pfizer Covid19 vaccine and on a similar timeline. Caller clarifies that 2 weeks later on 26Feb2021 she had ended up with horrible headache, dry heaves, headache, body temperature 104.4. She states that this lasted Friday night and Saturday night and Sunday she was feeling better. Clarifies that was the week of 26Feb2021. Caller states that her events were on a similar timeline and that her first vaccine was 14Jan2021 at 3:30 pm on Thursday. States that by 10 o'clock that night, injection site was sore. At 4 am, injection site was very sore. A couple of days later, her lymph nodes were swollen in her left leg, groin area, right arm under armpit. Adds that area under armpit was the size of her thumb. Also, on the left underneath her chest wall. She states that she has had breast cancer in that left breast. She states that the swelling went away completely, but that the groin area swelling took 2 weeks to go away. Unable to verbalize exact dates. Confirms that this was after the first vaccine and also occurred after the second vaccine. Caller then adds that she was feeling better Sunday, 28Feb2021 but that her husband then found her on the floor Sunday night at 8:45 pm. She states that she passed out. Monday she passed out again and was taken to the hospital where she stayed until 02MAR2021. Healthcare Provider also provides information that her son ran her to emergency room, and she is not familiar with the doctors there. Also, a doctor that she does not remember the third physician but it was a neurologist. Caller states that she was 155 lbs before when she was in the hospital - and now 160 lbs. States that she was dehydrated in hospital and did not eat a thing. Normally she runs around 160 lbs. States she had breast cancer so left arm cannot be used, so they used her right arm for both vaccines. caller adds that she had a cruise she was going to go on but refused to go on in 2020. States that she heard you will need to have a vaccination passport to travel in the future so she wanted to get vaccine. States she did not want to get covid. States that so many people have died. Caller clarifies that she was admitted to (Hospital Name) on 01Mar2021. Caller adds that she went to the hospital 2 weeks after the second dose. She states that is what makes them wonder if it is from the Covid vaccine. Adds that she is not saying that is what caused all of this, but that it is just a coincidence that it was exactly 2 weeks after the vaccine, exactly 2 weeks out when this happened. She states that she has been thinking if she should be wasting Pfizers time reporting this but it could be a coincidence or maybe a reaction. Caller adds maybe it is because she had 34 radiations, 8 chemo treatments, 1 year of Herceptine, and breast cancer. States that maybe she can save somebody else, or if a possibility, people can be prepared two weeks early. She adds that she is lucky she did not break an arm, leg. or bone. States that she doesn't know if maybe she can save some other person by sharing this information. Injection site sore: States that this was after both first and second vaccine. It stayed sore for about a week, and was just tender after that. If she touched it, she noticed, but it didn't hurt her from doing anything. With the first vaccine, injection site soreness started 14Jan2021 around 10 pm and completely resolved after about a week. She adds that with the second vaccine she also noticed injection site soreness that same day on 04Feb2021 around 10 pm also. She adds that it lasted about six days or seven days or so. It was the same way, tender the first day and then at 4 am was when it got really bad. That Friday 05Feb2021 was when it hurt worse. Adds that she went into hospital on 01Mar2021 on Monday. States she was feeling okay, stayed dizzy and confused and thought she was getting Alzheimer's or dementia but it cleared. At 11 pm on Sunday felt completely different, like the old her. States she was fine yesterday 15Mar2021. She had felt disoriented but is now feeling better and back to normal. Eratic Body Temperature: States that she started watching and recording her body temperature on 09Mar2021. She states that it was 104.5 on Friday, and Saturday and Sunday night she used a wet washcloth to her forehead. States that her body temperature initially was variable starting on 26Feb2021. She adds that it continued until Sunday 28Feb2021. On 26Feb2021, her body temperature was 104.5. She states that it was then low on Sunday 28Feb2021 and was 98 or 99. Adds that it had been erratic but that once the fever broke it has been between her normal which is 98.6 to 98.7. Adds that her and her husband know for sure that when she passed out the three times, her temperature was 94.4. States that her husband gave her aspirin for the temperature. Adds that her temperature has been between 97.9 to 94.9 and dropped to its lowest on Saturday 13Mar2021 at 10:35 am. She states that it is still doing this erratic behavior and that this morning it was 96 at 1 am and then 96.8 at 8 am. While on phone today, it is 97.1. Lymph nodes swollen: States noticed swelling at 4 AM 16Jan2021. States this occurred 4 am after both first and second injection. Occurred to groin area, right arm, and left arm. It was there for a couple of days and then it would just remind her it was there. The arm lymph node swelling went away after a few days, maybe before a week or so. The one in the groin was there for about two weeks. On a scale of 1 to 10, it was a 1.5 and was not something that people need to take an Advil or something for. Clarifies it was in the armpit except in the left side because they took those lymph nodes out during surgery in 2008. Also, she noticed lymph node swelling in the chest area. Lymph Nodes at second vaccine she also noticed them starting at about 4 am after the vaccine and it started hurting again. Caller reiterates both shots were given at 3:30 pm and then at 10 pm injection site gets sore.Then 4 am injection site gets more sore. She's been telling everybody to get the vaccine in the morning. Her symptoms lasted two weeks and then she was fine. Caller adds that her husband never felt a thing from receiving the vaccine. She states that the injection site was tender on her husband but gone the next day. Investigations: stated they looked at her in the hospital and said she was fine. The girl came back up and did more cultures and nothing grew. They were confused and so was she and she has been debating whether to call and waste time reporting but thinks that Pfizer needs to know what happened to her. Simvastatin: Adds that asked doctor if this caused her symptoms and he said no. Phillips colon: doctor 6 to 9 months later did scan, the next day was in emergency surgery and it was her appendix. It enlarged and had grown into the other organs. Doctor said it was a mess and it was ready to rupture as a precaution they wanted to remove it. Bayer product Code above expiration date states 0C09C and expiration is Mar2023. Thumb pink: thumb nail to finger print past where you bend it was where she noticed it was pink. States it is now 98% better. Friday 26Feb2021 afternoon at 1 pm, right thumb turned pink. She took a pen and marked where it was vertical and horizontally pink to scarlet in color. She put herself on antibiotics. She was not sure if maybe she cutting chicken and cut it, or closed finger in drawer. It swelled up twice the size, turned purple. Went all around the finger and it was hot. She thought it was going to pop off. She kept wondering what she was going to do to her thumb. She did jam it and cut herself 2 months ago. Clarifies it was right hand thumb. Treatment: took antibiotics, which she states they kept her on in the hospital in IV form. She started the antibiotics on Friday 26Feb2021. Took it Friday afternoon, Friday night, and Saturday and Sunday. She thought it was doing better Sunday night before she passed out. Clarifies Cephalexin, 500 mg daily (Keppra) three times a day and by mouth. Adds that she keeps this medication on her because she travels the world and it is good to have on hand since it is broad-spectrum. Passing out: 28Feb2021 Sunday night noticed the volume on television was driving her crazy and it was irritating. Around a quarter to 9 she got up to brush her teeth and go to the bathroom. She went pee and then fell off toilet. She got really really dizzy, and her husband was standing over her yelling asking what happened. She saw the wall and she did not know what happened. States she was out cold and he was calling her name but she did not hear him. She heard him asking what happened but it was in the distance. He got her to bed and about 20 minutes later (husband reports 30 minutes later) she was so dizzy and passed out again. She adds that this may have happened Saturday also because she was sleeping a lot and it was like she was seeing words repeat themselves over and over again and her vision would get very narrow. Her husband was note sure if she passed out on Saturday also, but said both times Sunday she was out cold. Monday 01Mar2021 she called her husband's office and woke up to the nurse on the other line screaming. She dropped the phone and heard her name being screamed over and over on the phone and when she picked it up the nurse said that she must have passed out even though she thought she was sleeping. The nurse got ahold of her husband in his office. She believes she passed out again Monday morning and was then in the hospital Monday and Tuesday. Hospitalization: On 01Mar2021, her husband is a physician and suggested she go to the hospital. She was trying to get ahold of her son and daughter in law. She sent them a text and called and they did not answer. Her sons phone was charging and when he looked at it he was on his way to her. She states that when she came to all three times, she was extremely dizzy foggy and confused. Adds that the nurse at her husband's office alerted her husband and he told her to stay in bed and her son came to help her and then drove her to ER. States she was there Monday 01Mar2021, and discharged Tuesday night 02Mar2021 about 4:30 to 6 pm. Caller does not want to file a report for her husband regarding the injection site soreness. She states it was like the flu shot. She clarifies that it was not his arm, it was the injection side. She states that these people who are going on and on about their arm hurting, it is the injection site. She states it is the injection site and will not be the arm. States that it is like the flu shot. States she does not want to file a report regarding her husband because it was injection site soreness and went away. Provides no additional information. Adds that this is a new drug and new disease and we do not know what the future holds Caller adds that she keeps a diary and started a diary so that she has everything recorded in terms of medical history. States that it is important that everybody do so. Family Medical History Relevant to AE(s): callers dad passed out at age 85. He found out he was diabetic and had heart issues. Also had a stroke at age 87 and passed away. Adds that between ages 85 and 87 he passed out every few months, he would do one of his passing out things. Caller also had a brother who passed out sitting at table and went forward into table. She states at that time her brother didn't realize he had stage 4 lung cancer, and her brother passed away 1 and a half years later. Caller adds that he smoked from ages 15 to 64, and quit at age 63 because the doctor told him to. No follow-up attempts possible. No further information expected.
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| 67 | 2021-03-31 | irritability, feeling abnormal |
Pressure Headache that lasted 12 days, right facial tingling around day 5, visual disturbances on d...
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Pressure Headache that lasted 12 days, right facial tingling around day 5, visual disturbances on day 2, foggy thinking 10-12 days, fever 100.6 after 30 hours, body aches lasted 48+ hours, irritability for 7+days, neck pain lasting 7-10 days with thoracic pain lasting 12-14 days, left arm soreness lasted 4-5 days, loss of appetite lasted 2 days
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| 67 | 2021-04-02 | loss of personal independence in daily activities |
Day 1 (evening) -- vax Day 2 & 3 -- high fever (101, my normal 97.4), anorexia, weakness, curled up ...
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Day 1 (evening) -- vax Day 2 & 3 -- high fever (101, my normal 97.4), anorexia, weakness, curled up in bed Day 4 & 5 -- low energy, achey, more soreness in arm, itchiness, moderate fever (99-100) Day 6 -- tired, arm still itchy and sore, temp normal Day 7 -- felt GOOD, resumed normal activities Day 8-10 -- moderate-to-severe headache (which I never get), fever on and off (99-100) Day 11 ---- > present (Day 33) -- mostly recovered but occasional slight headache and occasional dizziness
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| 67 | 2021-04-03 | hallucination |
First dose: sore arm. Second dose: severe chills, headaches, nausea, hallucinations lasting almost ...
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First dose: sore arm. Second dose: severe chills, headaches, nausea, hallucinations lasting almost 28-36 hours. Tylenol helped, but switched to Excedrin for better results. Queasiness remains after 36 hours, but better.
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| 67 | 2021-04-04 | memory impairment |
Previous tendon pain at joint sites (from Lyme disease) returned full force (had been gone since 201...
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Previous tendon pain at joint sites (from Lyme disease) returned full force (had been gone since 2012); Previous headache became constant (last headache was 1998); Memory issues and word-finding problems (previous Lyme symptoms which had been gone since 1995); Constant nausea (only alleviated partially by acupressure band on wrists) These symptoms are still ongoing...it's day 17 post 2nd vaccination.
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| 67 | 2021-04-05 | anxiety, irritability, depression |
Irritability, depression, anxiety, nausea, headache, fever, joint pain, muscle aches and pain, chill...
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Irritability, depression, anxiety, nausea, headache, fever, joint pain, muscle aches and pain, chills, electrolyte imbalance, dehydrated, low potassium and magnesium, muscle cramping in arms, hands, legs, calves, feet
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| 67 | 2021-04-05 | sleep disorder |
Adverse reaction is that it made my tinnitus worse. I've h ad tinnitus for about 10 years but is w...
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Adverse reaction is that it made my tinnitus worse. I've h ad tinnitus for about 10 years but is was not as loud as it is now and didn't interfere with my sleep. However, since the vaccination, I've noticed the tinnitus is must louder and does interfere with my sleep. The tinnitus is most noticeably worse in my left ear and there is a pressure in the left ear which makes it feel like it needs to "pop" but I can't get it to pop.
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| 67 | 2021-04-07 | anxiety |
Approximately 10 minutes after patient received her 1st dose of the Pfizer COVID-19 Vaccine she told...
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Approximately 10 minutes after patient received her 1st dose of the Pfizer COVID-19 Vaccine she told her daughter she didn't feel well. Patient reported to staff, through her daughter, that she felt lightheaded/dizzy and felt "anxious on [my] heart". Patient was taken to an exam room and was assessed by an RN team. She had an elevated blood pressure, but regular pulse and respiratory rate. She also described, via interpreter, a tingling in her hands and continuously rubbed her left arm. Despite resting for 15 minutes, patient's symptoms did not improve and she was advised to present to the ED via EMS due to the "anxious" feeling on her heart and hand tingling. The patient and her daughter were agreeable to this plan.
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| 67 | 2021-04-07 | feeling abnormal |
It started within 15 minutes, very vague sensations so I wasn't even sure it was happening. Tinglin...
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It started within 15 minutes, very vague sensations so I wasn't even sure it was happening. Tingling in lips, metallic taste, kind of pin prick sensation at back of tongue. Tingling very gradually got stronger and recognizable. At about 2 hours after the vaccine, I checked the mirror and inside my upper lip was swelling. Entire event lasted about 2 1/2 hours, resolved without treatment.
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| 67 | 2021-04-08 | insomnia |
My mild tinnitus overnight has been amplified to an unbearable loud constant hissing. Can?t sleep, t...
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My mild tinnitus overnight has been amplified to an unbearable loud constant hissing. Can?t sleep, the sound is literally unbearable.
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| 67 | 2021-04-09 | amnesia |
My mom (the patient) has a complete no recollection of what happened yesterday. She could not remem...
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My mom (the patient) has a complete no recollection of what happened yesterday. She could not remember even having the vaccine nor what she did that day. I showed her the vaccine record and the photos we took. As I spoke to her, she kept on repeating and asking me the same questions she had asked 15 minutes ago. My dad and I saw her took her blood pressure medicine around 7:30 a.m. while we were in her room. I was afraid she will not remember her taking the medication so I removed her medicines from her cabinet. Sure enough, at 8:30 a.m she was looking for her medications and told me that she need to take it since she had not taken one this morning. :( My mom's memory has always been sharp and we had never had this issues before.
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| 67 | 2021-04-09 | excessive sleepiness, feeling abnormal |
About 14 hours after the second vaccine dose, I awoke with chills shaking my body even though I didn...
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About 14 hours after the second vaccine dose, I awoke with chills shaking my body even though I didn't feel cold. I got out of bed and became nauseous and lightheaded. Later that morning I was no longer nauseous but was very tired. I slept most of the day for two days. After two days I was still tired and had a headache. My temperature was 101 (that was the first time I took it). I was still tired and my head was buzzy for several weeks. FYI I had no symptoms after the first dose.
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| 67 | 2021-04-09 | sleep disorder |
Severe intense abdominal/stomach pain that started about 7:00pm. The pain was (still is) an very sh...
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Severe intense abdominal/stomach pain that started about 7:00pm. The pain was (still is) an very sharp and burning pain that come and goes in waves. It lasted with me most of the night, making it impossible to sleep. The last time I looked at the clock before having to get up to get ready for work was 12:30am. During my workday (Friday, April 9th) the pain would come and go throughout the 9 hours I was at work. Again, becomming more severe and intense after I got home. The pain is so severe that I honestly wasn't sure if I was going to wake up this morning. As I write this (Saturday, April 10, 2021 at 9:04am) the waves of pain keep on a coming. I have also had episodes of burping, which seems to lighten the pain a bit. Right now the riht side of my stomach/abdomen is really sore. I had a "wave" of severe, intense pain while writing this about 5 minutes ago.
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| 67 | 2021-04-12 | anxiety |
Tightness in chest, visible tremors in hands, tightness in throat Vital Signs: BP 174/104 HR 106 O2...
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Tightness in chest, visible tremors in hands, tightness in throat Vital Signs: BP 174/104 HR 106 O2Sat 98 Skin Signs: Cool and dry, diaphoretic Respiratory: Breath sound clear bilaterally, diminished but clear wheezing Initial Treatment: Patient felt anxious, so took Xanax before calling for help. She called for attention and stated she had difficulty breathing, different from asthma. Stated she could feel her BP was high - has hx of this. Taken to triage. 11:35 AM Vital Signs: 196/110 HR 106 O2Sat 98 Skin Signs: Clammy, diaphoretic 11:39 AM Vital Signs: BP 178/102 HR 106 O2Sat 98 Follow up Treatment: EMS activated after first dose of Nifedipine Discharged with ambulance
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| 67 | 2021-04-12 | feeling abnormal |
"Not feeling right"; flush; HTN; pain to R arm, up to shoulder and neck; light headed; legs feeli...
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"Not feeling right"; flush; HTN; pain to R arm, up to shoulder and neck; light headed; legs feeling numb and unable to ambulate "legs feel rubbery"; sore throat.
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| 67 | 2021-04-12 | feeling abnormal |
No adverse effects after my first or second shot. Then, about a week and a half after the second sh...
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No adverse effects after my first or second shot. Then, about a week and a half after the second shot, I began to experience dizziness. This eventually led to two terrible (but brief) episodes of vertigo (room spinning wildly out of control). Have had dizziness and fuzzy head ever since. Also, am experiencing tinnitus...not so noticeable at times but other times it is quite pronounced. Can't seem to shake any of these symptoms, though they seem to be lessening a bit each day. From what I understand, this is happening to many others as well. Am not sure if blood type has anything to do with it but mine is A Negative.
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| 67 | 2021-04-16 | feeling abnormal | Headache Nausea Chills Fever Body aches Brain fog |
| 67 | 2021-04-16 | mental status changes |
entered room drooling . right sided neglect BP elevated . not following command send to ER A...
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entered room drooling . right sided neglect BP elevated . not following command send to ER Admited to hospital with CVA PCP Note upon return - Patient is a 67-year-old female with past medical history of hypertension, MS, dementia, CHF, chronic kidney disease and hyperlipidemia who was sent from the facility to the emergency room for altered mental status and possible CVA. In the emergency room, blood pressure was elevated at 170/100 and she was noted with more pronounced weakness in left upper extremity and lower extremity and left gaze. Neurosurgery was consulted and deemed patient a poor candidate for TPA due to recent GI bleed. Stroke workup was negative for acute findings and a brain MRI ×2 was negative. EEG was ordered to rule out seizure and it was normal and neurologist recommended to start patient on Keppra. Patient was initially started on aspirin which was stopped due to drop in H&H. Patient was also noted with low-grade fever and infectious workup including blood cultures, UA and extensive imaging did not have evidence of infection and COVID-19 was negative. Social services spoke to patient's sister who is the POA regarding advanced directives and she requested to change advanced directives to DNR/DNI/no PEG and orders noted in chart. Patient's symptoms progressively improved and discharged back to the facility and resting in bed comfortably in no acute distress
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| 67 | 2021-04-17 | feeling abnormal |
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell...
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Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-17 | hallucination |
Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous rep...
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Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 04Mar2021 10:00 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as SINGLE DOSE for COVID-19 immunization at the doctor'ss office. Medical history included arthritis and was diabetic. Concomitant medications were not reported. It was reported that right after the first dose probably first, second, or third night in Mar2021 the patient had hallucinations. The patient also had headaches and sharp pain through arm/arm sore a couple of days after the first dose (probably started the next day or even the same day) which come and go. The patient recovered from the events in Mar2021 (a week or week in a half maybe two weeks before getting second dose). Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-17 | hallucination |
Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration...
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Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration inside of the left ankle and bottom of heel; she is not experiencing any arm pain. It is in her ankle and feet; Hallucinations; ankle swollen; This is a spontaneous report received from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Mar2021 10:00 (Batch/Lot Number: EN6208; Expiration Date: Jun2021) as a single dose for COVID-19 immunization. Patient received the first dose on 04Mar2021 10:00 in the left arm (Batch/lot number: EN6200, Expiration Date: Jun2021) and she had headaches, arm ache, and hallucinations which would go and come. When she would try to sleep, the hallucinations would go and come but then the hallucinations stopped prior to getting the second dose. Headaches started a couple of days after the first dose probably started the next day and started coming and going. This stopped prior to the second dose probably a week or week in a half maybe two weeks before getting second dose. The headache only lasted about half a day, it wasn't that bad. She recovered completely. Arm sore, red only happened with the first dose as her arm did not hurt at all after the second. This started the next day or even the same day but she kept it comfortable and probably stopped within the first week and it did not come back either. She has recovered completely. Sharp pain through arm go and come. This started after the first dose so in that week or week in a half area and it stopped about at least a week before the second dose somewhere in that period of time. She has recovered completely. Hallucination: she was laying down at night and something would come across her head that she was not thinking. It started right after the first dose probably first, second, or third night but it stopped like all the rest of it in same period of time. She had recovered completely prior to getting the second dose. Medical history included arthritis and diabetic. The patient's concomitant medications were not reported. Patient had the flu vaccination for the first time in Oct2020 or Nov2020 and did have a headache and she has never taken the flu vaccine before. The patient had side effects from the vaccine she received on 25Mar2021. Her ankle was swollen on 28Mar2021 but that went down on 30Mar2021. This has left discoloration inside of her left ankle and bottom of her heel and it was sore from 30Mar2021 and ongoing. It was not red, tender, or bruised. The bottom of her heel hurt when she put pressure on it and walked on 31Mar2021. It was ongoing but was off and on and it has worsened. She had her feet up on the bed. As treatment, patient used heat, ice, and has been elevating her feet. She called her doctor and doctor told her to keep doing it since she has been doing it since Monday. With the second shot, she is not experiencing any arm pain. It is in her ankle and feet and then the hallucinations still go and come and she sees images that come still but do not stay they just go and come. After the second dose, she had this last night and the night before last, she would not be thinking it but it would appear in her mind and she was wondering why it was doing that but she thought maybe a week or two it will stop and come down. This started on 28Mar2021, Sunday after the second dose and is still going on. Outcome of the event ankle swollen was recovered on 30Mar2021, of the event arthralgia was unknown, and of the other events was not recovered.
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| 67 | 2021-04-17 | loss of personal independence in daily activities |
Short-term manifestation of fever-like symptoms, chills, body aches, fatigue, dizziness occurred app...
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Short-term manifestation of fever-like symptoms, chills, body aches, fatigue, dizziness occurred approximately 1 week after 2nd Pfizer dose. These symptoms faded within 24h of onset. However vertigo, dizziness, and light-headedness began immediately following the onset of other symptoms, and have persisted for 1 month. Lack of prior history of vertigo or light-headedness, lack of recent signs of illness prior to vaccine, and timing of the vertigo setting in immediately after the other symptoms and within a week of the vaccine lead me to believe the symptom is a result of the vaccine and/or its side effects. Have not yet scheduled medical visit since I was hoping it would go away, but am planning to do soon so since the vertigo sometimes impacts ability to function normally.
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| 67 | 2021-04-19 | mental status changes |
Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiog...
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Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction.
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| 67 | 2021-04-20 | anxiety |
Patient reported tightness in lower midline jaw. Vitals were taken : 15:40 BP was 157/91 (Right arm...
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Patient reported tightness in lower midline jaw. Vitals were taken : 15:40 BP was 157/91 (Right arm), pulse 79, and O2 sat 95%, BP taken again on L arm 175/119, BP taken again on right 154/96. Swapped cuff and vital taken again at 15:55 Right arm BP 164/105 and taken on Left arm 171/115, pulse was 63 and O2 sat 95%, Vitals were taken again at 16:05 with Blood pressure 179/131 on right arm and 70 pulse and 95% O2 and EMS was called for transport to Hospital. During this time destress techniques were utilized however pt appeared not to be in an anxious state.
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| 67 | 2021-04-21 | crying |
1st shot on 3/28 .. reaction 3/31.. ALL over body pain.. hit EVERY weak spot, I suffer w/ OA, FM.. t...
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1st shot on 3/28 .. reaction 3/31.. ALL over body pain.. hit EVERY weak spot, I suffer w/ OA, FM.. the WORST being right shoulder & entire arm. (Shot was given in left arm.) I've had elbow pain before, but this feels like a rotator cuff tear! Shoulder>upper & lower arm severe pain & weakness! NEVER had that before! 2nd shot 4/19. Next day 4/20 had BOLTS of excruciating pain, esp. in lymph nodes (same left side, as shot.) And SEVERE COLD, no matter under all quilts. Almost went to ER... OVERALL feverish & body pain still very bad. Am scheduling a mammogram to check out lymph nodes. The vaccinations heightened every inflammation I had.
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| 67 | 2021-04-22 | anxiety |
Patient received first dose of Pfizer COVID-19 vaccine, lot #EL9264, on 1/30/2021 at 1300. Patient h...
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Patient received first dose of Pfizer COVID-19 vaccine, lot #EL9264, on 1/30/2021 at 1300. Patient has a history of allergies to Bactrim (hives), Clindamycin (unknown), nitrofurantoin (rash), penicillins (unknown), yellow dyes (hives), and azithromycin (unknown). When asked, patient states all of her allergies result in a rash treated with Benadryl--has not experienced anaphylactic shock or any life-threatening reactions. Patient was in waiting area and noticed that she felt flushed. Patient was brought back to exam room and examined by pharmacist and nurse. Erythema present at injection site, down arm, on neck, and face. Skin was flat and warm. Patient reported feeling anxious, but no nausea, dizziness, shortness of breath, or other symptoms. No swelling was noted in extremities or in lips or tongue. Blood pressure was 170/110 and heart rate was 130 bpm. Patient was given diphenhydramine 75 mg PO (was offered 50 mg but patient reported she typically takes 75 mg for past allergic reactions) and asked to stay for 30 more minutes. After 30 minutes, blood pressure decreased to 150/90 (pt has documented history of white coat syndrome), skin was less erythematous and the area of redness decreased. Asked patient if a family member could be called to pick her up; patient declined stating she lives just a few minutes away. Patient was instructed to seek emergent care if she develops difficulty breathing or other signs of anaphylaxis.
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| 67 | 2021-04-24 | nervousness |
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject...
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Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
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| 67 | 2021-04-26 | feeling abnormal |
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pr...
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hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation . Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported. The patient experienced fall on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed on 17Mar2021 with outcome of recovering , dizziness on 16Mar2021 with outcome of not recovered , sleeping a lot on 17Mar2021 with outcome of not recovered , hot and cold on an unspecified date with outcome of unknown , very ill on an unspecified date with outcome of unknown , felt horrible on an unspecified date with outcome of unknown , clammy on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy on an unspecified date with outcome of unknown. The events fall and contusion were considered Important Medical Events. The remaining events were non serious. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-26 | sleep disorder |
Muscle and joint aches all over, mild headache, lethargy, red and burning eyes, fever of 100.4, coul...
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Muscle and joint aches all over, mild headache, lethargy, red and burning eyes, fever of 100.4, could not get warm (especially hands and feet), trouble falling asleep. Took 400mg IBU and went to bed. At ~2:00 AM on 03/17/2021, woke up sweating profusely. Got a drink of water, went back to sleep, woke up at ~6:00 AM with all symptoms resolved.
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| 67 | 2021-04-27 | feeling abnormal |
She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that ...
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She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that for 3 days she couldn't work; This is spontaneous report received from Pfizer Sponsored Program Support from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 09:30 (Lot Number: EN6207) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient experienced nausea on 15Mar2021 18:00, extreme dizziness on 15Mar2021 18:00, fatigue/bad enough that for 3 days she couldn't work on 15Mar2021 18:00, she was 'bouncing off the walls' on an unspecified date, unsteadiness on an unspecified date. She went on 15Mar2021 to get her first shot and then she was went for her second vaccine this past Saturday. Patient stated they denied giving her the 2nd dose of the covid vaccine after hearing about her side effects form the 1st one. She would like to know whether she needs to get the 2nd dose. She had pretty bad reactions to the first shot. She got the shot around 09:30 in the morning and by 6 pm she felt the reactions. Patient reported the following side effects form the 1st dose of the covid vaccine: nausea, extreme dizziness and fatigue, bad enough that for 3 days she couldn't work. She was 'bouncing off the walls', unsteadiness and spent the next three days in bed due to fatigue. There was no event require a visit to emergency room and physician office. There was no prior vaccination (within 4 weeks) and no adverse event following prior vaccinations. The outcome of event nausea was recovered on 16Mar2021, extreme dizziness and fatigue/bad enough that for 3 days she couldn't work was recovered on 18Mar2021, She was 'bouncing off the walls' was recovered on an unspecified date, unsteadiness was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-28 | insomnia |
Her lungs did the same thing where they had closed; Her lungs did the same thing where they had clos...
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Her lungs did the same thing where they had closed; Her lungs did the same thing where they had closed/her nose did the same thing where it closed as well/only it was a lot worse with her lungs and her nose; her nose did the same thing where it closed as well; She was breathing through her mouth because she couldn't breathe through her nose.; She had sat up for 4 nights trying to sleep.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8733) via an unspecified route of administration into left arm on 30Mar2021 (at the age of 67-year-old) in the morning as single dose for COVID-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. Historical vaccines include: INFLUENZA VACCINE on an unspecified date for immunization where she got sick for a week and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 09Mar2021 08:30 AM (at the age of 67-year-old) for COVID-19 immunization and feeling like her lungs were starting to close up and her nose closed up completely, hard time breathing when doing anything that was exerting herself, she still had a hard time with her breathing and short of breath. It was reported that patient got her second dose on 30Mar2021 in the morning and on 31Mar2021 almost the same thing pretty much happened as the first one, only it was a lot worse with her lungs and her nose. Her lungs did the same thing where they had closed and her nose did the same thing where it closed as well. She already had everything ready to use for nebulizing and that opened her lungs but it didn't open her nose. It was further reported that since 31Mar2021 she had sat up for 4 nights trying to sleep and she was breathing through her mouth because she couldn't breathe through her nose. The patient went to her doctor's clinic where she was given treatment for the events reported; she was put on a heavier nebulizer; that kind of opened up her lungs and her nose and then her doctor also put her on prednisone. Outcome of events "she was breathing through her mouth because she couldn't breathe through her nose" and "she had sat up for 4 nights trying to sleep" was unknown while for all other events was recovering.
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| 67 | 2021-04-30 | anxiety |
tingling to the feet, arms and hands; numbing to the feet, arms and hands; vitamin D was low; anxiet...
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tingling to the feet, arms and hands; numbing to the feet, arms and hands; vitamin D was low; anxiety; palpitations; bumpy hives in left side of face, the same side of the body as the shot; rash and bumpy hives in left side of face; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm left on 25Feb2021 (at the age of 67-years-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included chronic back pain and hysterectomy from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL XL SANDOZ) taken for blood pressure abnormal; estradiol taken for an unspecified indication, both start and stop dates were not reported. Clinical course was as follows: The reporter was worried sick and wanted to confirm that what she has had is what other people are having. Had the Pfizer first dose on 25Feb2021 and second dose on 18Mar2021, 21 days after. A couple of hours after the first dose, had a rash and hives on one side of the face, the same side of the body as the shot. Went away the next day. Between the first and second dose, one arm was having tingling and numbing to the feet, arms and hands. Got worse and worse after the second shot. Went to primary doctor 2 times, who said that it is her immune system reacting to the Covid vaccine. It has been almost four weeks, will be four weeks this Thursday after the second shot. Is getting worried. Read up something saying that people may have multisystem inflammatory system response. Read this in the Covid 19 information from Pfizer. Confirmed that caller is referring to the Covid 19 vaccine. As she is talking now, her left arm and feet are tingling. Has doctor appointment tomorrow to rule out anything in the spine. Has a history of back pain. Back pain never causes tingling like this, only pain and is not usually in her arm. Even talking now, forearm is tingling and the feet. As a nurse, she is thinking it could be all kinds of diseases. She thought to herself does she have MS or ALS, but the doctor tested everything, and all tests were negative, there is nothing that supports any sort of muscular problem. Decided to call Pfizer to see if anyone else has tingling. Saw primary doctor 09Apr2021, has another appointment tomorrow behind her back. Has to rule everything out, so she may need an MRI. Has chronic back pain, it hurts, but usually no tingling. This has gone on many years with no tingling. It is in her hand and forearm. Read today for the first time that it may be multisystem inflammatory syndrome. Has been seen in the office two times for the numbing and tingling. They tested her for Lupus, and everything was normal. Just her vitamin D was low. Event details was as follows: Numbing and tingling: Started right after first shot, 25Feb2021, like a week after. Rash and bumpy hives in left side of face: and to neck, was in same side of body as shot which was in the left arm. Started 6 hours after the first shot. Was a bumpy rash but no itching. Looked at her face and could feel the bumps. Went away the next day and really subsided. Could feel a little bit but not bumpy. Lasted a few hours over night. Treatment: Put some diphenhydramine (BENADRYL) cream on it. Did not have rash after second dose of the vaccine. Numbing and tingling: After the second shot on 18Mar2021, saw the doctor, on 22Mar2021, 4 days after the second shot, for the numbness and tingling. The tingling had gone down from a 10 to a 6 or 7. Has been having anxiety and palpitations. These symptoms occurred a week after the shot. She never thought about the shot. Treatment: nothing for numbness and tingling. Was told to take naproxen sodium (ALEVE), but nothing major. Has not been taking anything. Tomorrow at 2:00pm, has appointment with spine doctor to see what he thinks. Has never had tingling before with the back pain and no tingling in the arms, why in the arms. The outcome of the events bumpy hives in left side of face, the same side of the body as the shot and rash and bumpy hives in left side of face was recovered on 26Feb2021, while of the rest was unknown.
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| 67 | 2021-04-30 | nervousness, anxiety |
bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc...
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bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-05-07 | insomnia |
cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appeti...
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cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appetite; Sleep pattern is bad/she cannot fall asleep until 0400 and then wakes right back up around 0800; Feels rough with fine bumps at times; Feels rough with fine bumps at times; Itches at times; Rash on outer aspect of arm; Tightness, uneasiness in chest; Palpitations, Fluttering in Chest; Palpitations, Fluttering in Chest; Easily Winded; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 16Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), then the second dose on 07Apr2021 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), both via an unspecified route of administration, at the age of 67-years-old, administered in arm left as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2002 and ongoing, ongoing diabetes mellitus, penicillin allergy from an unknown date and unknown if ongoing, became really sick, really fast, uncertain if was Covid 19 from Feb2020 to an unknown date and chest discomfort from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), glyceryl trinitrate (NITROGLYCERIN), both taken for chest discomfort; dulaglutide (TRULICITY) taken for an unspecified indication, all from an unspecified start date and ongoing. The patient previously took morphine and codeine and experienced drug allergy. The patient was at her eye doctor on 02Apr2021 and decided afterwards to have her grandson take her to the Emergency Room (ER) for some tightening and uneasiness she had been having in her chest over the preceding days. She also felt some palpitations, they were fast, then slowed down; did not feel labored. She went to the ER and was there for 8 hours. They told her that her cardiac enzymes were extremely elevated. After the cardiologist reviewed her results she was allowed to go home. She went to her regular cardiologist on 05Apr2021. That cardiologist went over her tests results and said that while it was not normal results for her he didn't find them too worrisome. He stated that just because her enzymes are elevated does not mean she is in trouble. He scheduled her for a Dobutamine Stress Test on 07Apr2021. She has been trying to get the results of this stress test from the doctor's office but has not been successful in doing so. Says that once she completed the Stress Test on 07Apr2021 she went to get her second dose of the Covid Vaccine. She was still having her symptoms when she got her second vaccine and they have continued since. She saw her endocrinologist who went over blood work with her. The endocrinologist told her that her blood glucose level was very good and her A1c was a 5.5. The endocrinologist was concerned because usually the A1c is between 6 and 7. Patient was 5 foot 6- and one-half inches. Tightness, Uneasiness in chest: Stated it is not pain, just an uneasy, uncomfortable, fluttering feeling. Palpitations, Fluttering in chest: Not a labored feeling, goes fast, then slows down, not constant. Rash on outer aspect of arm: Extends from her wrist to about 2-3 inches below her elbow. Outside of arm, not on the inner part of her arm. Feels rough with fine bumps at times; then will feel smooth again. Itches at times. She uses calamine lotion, which does help to relieve the itching and smooth the skin. Stated it eventually does come back though. Easily Winded: She has had respiratory conditions all of her life. This winded feeling, she has been having is different than that she stated. She gets the fast heartbeat really quick, can almost hear it; becomes winded and sits down. The episodes last about 15 minutes. She has had no appetite; she has lost almost 15 pounds in 2 months. Her weight was 223 pounds 2 months ago and now weighs 211 pounds. She mentioned her sleep pattern is bad. Some days she cannot fall asleep until 0400 and then wakes right back up around 0800. The patient underwent lab tests and procedures which included blood glucose: 100 on 22Apr2021, blood pressure measurement: 128/62 on 21Apr2021, body temperature: 97 degrees fahrenheit on 21Apr2021, haemoglobin: 5.5 on Apr2021, heart rate: 78 on 21Apr2021, myocardial necrosis marker: extremely elevated on 02Apr2021, oxygen saturation: 98 % on 21Apr2021. Therapeutic measures were taken as a result of rash on outer aspect of arm, Feels rough with fine bumps at times and Itches at times. The outcome of the events Itches at times, Feels rough with fine bumps at times, Rash on outer aspect of arm, Easily Winded was not recovered; Palpitations, Fluttering in Chest and Tightness, uneasiness in chest was recovering, while of the rest was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-05-10 | insomnia |
Low grade fever; strong muscle aches; still cannot sleep.; This is a spontaneous report from a conta...
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Low grade fever; strong muscle aches; still cannot sleep.; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EM9810, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:00 as single dose for covid-19 immunisation. Medical history included osteoporosis, BRCA 2. patient had known allergies for Sulfa and ceclor. Concomitant medication included estradiol. The patient previously took first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number EL3247), via an unspecified route of administration, on right arm on 15Jan2021 04:30 PM at single dose for COVID-19 immunization. On 06Feb2021 22:00, patient experienced Low grade fever and strong muscle aches throughout body that were so bad as she has not been able to sleep. Patient was not pregnant at the time of vaccination. Patient did not received treatment for the adverse event Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequelae.
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| 67 | 2021-05-10 | sleep disorder |
Patient and I spoke on May 7th, 2021. Her contact information was referred to me by one of the Call...
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Patient and I spoke on May 7th, 2021. Her contact information was referred to me by one of the Call Center staff members. Patient reported that she received her first COVID-19 vaccine (Pfizer) on 2/17/2021 at Health Department. She reports that she is typically "fine with shots, no problem", but when she received her first dose of the Pfizer vaccine "it immediately started hurting". She reported taking round the clock Advil/Motrin and "could feel a knot and radiating into crease of arm". She reported difficulty raising arm to put bra on and awaiting in the middle of the night due to pain. She stated she presented 21 days later for her 2nd dose (3/10/21- right arm) and still had persistent pain in left arm. She stated she has seen a surgeon due to the pain and that they x-ray was negative. She states the surgeon told her that a nerve was affected and gave her a shot of steroids. She reports this has not resolved the pain and that she is taking diclofenac 75 mg BID with pain unresolved. States she has a f/u appt with provider 5/27/21 and will keep appointment.
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| 67 | 2021-05-13 | insomnia |
blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a...
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blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a spontaneous report received from a contactable consumer (reporting on herself). A 67-years-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 09Mar2021 10:15 as single dose for COVID-19 immunization. Medical history included hypertension, blood cholesterol increased, obesity , goitre , sciatica , arthritis, fibromyalgia, all from an unknown date and un-known if ongoing. Concomitant medication(s) included meloxicam (MELOXICAM); gabapentin (GABAPENTIN); levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen, sulfa and synthroid and experienced drug hypersensitivity, First dose of BNT162B2 on 16Feb2021 09:15 for covid-19 immunisation The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that patient was up at 5:30 am and started seeing gray splotches and then she got nauseous and started blacking out. It happened again about 10 minutes later and she barely made it back to bed be-fore the whole thing stopped. When she woke up later she was still a little light headed. The out-come of the events was recovered on an unspecified date.
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| 67 | 2021-05-18 | insomnia |
extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that s...
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extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; could not walk/she was not able to walk; she was not able to walk or sleep for two weeks due to the spasms and pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Apr2021 at 11:30 (Batch/Lot Number: ER8731) as single dose, for covid-19 immunization. Medical history included "gluten" (reported as past drug history), hypothyroidism, fibromyalgia, mitochondrial retrovirus and obese. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL), sertraline, colecalciferol (D3), antioxidants and "pregneolon"; all taken from unspecified dates, for unspecified indications. Patient previously took the first dose of BNT162B2 (Batch/lot number: FR2613) on 22Mar2021 in the left arm for COVID-19 immunization. On 15Apr2021 at 10:00 (three days after the second dose), patient had extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk. Her ER visit for pain yielded a script for hydromorphone and cyclobenzaprine. Even with these drugs, she was not able to walk or sleep for two weeks due to the spasms and pain. It has been three weeks since the 2nd dose, and still have limited standing time, due to the after effects. I'd get the vaccine again, but the level of pain was extremely bad. Information on Lot/Batch number was available. Additional information has been requested.
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| 67 | 2021-05-24 | loss of personal independence in daily activities, sleep disorder, thinking abnormal |
I developed tinnitus which is extremely annoying one week after my second dose of Pfizer Covid-19 va...
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I developed tinnitus which is extremely annoying one week after my second dose of Pfizer Covid-19 vaccine. My ear doctor said there is nothing I can do to get rid of this condition. It hit exactly one week after my second shot. It persists. It interferes with my sleep and with my thinking and with my activities of daily life. It's quite terrible.
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| 67 | 2021-05-25 | insomnia |
Immediately after the injection I had pinching needles in my tongue which went away after a while wi...
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Immediately after the injection I had pinching needles in my tongue which went away after a while within a few hours I had heaviness and numbness and tingling in both arms. and that night I started with heaviness in my lower legs and a feeling that I couldn't fully feel my lower legs, and tingling and numbness around my toes and top of my foot. It felt like someone was squeezing my toes. I had the vaccine about 4 months ago but I still have the symptoms. It is not as intense but I still have them. I have been to two neurological doctors. I called my primary care doctor immediately after my vaccine and they did an EMG test where they said it was a mild Gillian Barre response. I also have fatigue and insomnia.
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| 67 | 2021-05-25 | sleep disorder |
This is a 67-year-old female with a history of hyperlipidemia, depression, anxiety, hypothyroidism a...
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This is a 67-year-old female with a history of hyperlipidemia, depression, anxiety, hypothyroidism and presents for complaint of acute onset abdominal pain, vomiting and diarrhea. Noted that pain awoke her from her sleep this morning. Initially located in the epigastric region but states the pain is worse in the right lower quadrant. She's had several episodes of diarrhea today as well as one to 2 episodes of vomiting. She has a history of hysterectomy. Last known normal bowel movement was this morning. Review of Systems Constitutional: Negative for chills, fatigue and fever. HENT: Negative for facial swelling and trouble swallowing. Respiratory: Negative for cough, shortness of breath and wheezing. Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Positive for abdominal pain (RLQ). Negative for diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria and frequency. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash and wound. Neurological: Negative for weakness, light-headedness and headaches. Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.
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| 67 | 2021-05-26 | feeling abnormal |
tested positive on the 12Mar2021; feeling bad; lost taste and smell; lost taste and smell; had feeli...
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tested positive on the 12Mar2021; feeling bad; lost taste and smell; lost taste and smell; had feeling chills; body ache; headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204; expiration date: Jun2021), via an unspecified route of administration in shoulder on 05Mar2021 (at 67-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient started feeling bad on Monday 08Mar2021, 3 to 4 days later. After she was feeling bad the whole week, she tested positive on the 12Mar2021. The patient got all the symptoms what people said, it's like having the COVID and she lost taste and smell, she had feeling chills, body ache, headache and all that. So, week later she went for a test COVID test and she tested Positive and the test was on 12Mar2021. Her second shot was due on 26Mar2021. Feeling bad was reported as worsened from 09Mar2021. The outcome of event feeling bad was not recovered. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-05-27 | sleep disorder |
Pain began in right knee ( felt like nails being driven through my knee), moved into right hip ( had...
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Pain began in right knee ( felt like nails being driven through my knee), moved into right hip ( had a sensation of burning pressure) Pain was moderate to severe and kept me awake . Contacted Dr. and was given prescriptions for steroids and Diclofenac Sodium. Scheduled appointment with Sports Medicine Dr. His suggestion was to attend Physical Therapy.
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| 67 | 2021-05-27 | sleep disorder |
On Thursday, 3/18, I woke up at 3:30 am extremely dizzy with everything moving around me. Sitting u...
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On Thursday, 3/18, I woke up at 3:30 am extremely dizzy with everything moving around me. Sitting up was better but upon laying down, the extreme dizziness returned. I was still dizzy when I finally fell back asleep. In the morning, I nearly passed out & was in a cold sweat when I got up. Gatorade helped. My PCP's office said it was probably a vaccine reaction. I continued to feel rather light headed & neck pressure & by Tuesday, 3/23, I had a lot of body aches, diarrhea, I was definitely light headed & felt like I could pass out. Over the next days, my blood pressure was very unstable. This random blood pressure issue continued & then the Premature Ventricular Contractions (PVC's) began to increase in spite of the Metropolol. They became very frequent causing light headedness & neck pressure. On 4/12, I went to the ER because my blood pressure was 185/50, heart rate 92. Every 3rd beat was a PVC. The cardiologist changed me to Verapamil 120 mg/day. My condition deteriorated especially in the 3 days prior to the ablation. I was short of breath with weak extremities. The ablation was done on 5/25 & the Cardiologist said I was having PVC's every 2 seconds. I am currently recovering from the procedure. Prior to the 2nd vaccine shot, my PVC's were well controlled by Metropolol to 18% from the 21% in February 2019 prior to taking Metropolol. My blood pressure was consistently normal as well.
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| 67 | 2021-06-02 | agitation |
she was so high/she was out of her mind; This is a spontaneous report from a contactable consumer (p...
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she was so high/she was out of her mind; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8736, expiration date: unspecified), via an unspecified route of administration, administered in left arm (left upper arm) on 17May2021 11:00 as single dose for covid-19 immunization. Previously the patient had first dose of BNT162B2 (Batch/Lot Number EW0161, expiration date: unspecified) via unspecified route of administration at left arm (Left upper arm) (at age of 67 years) on 26Apr2021 for covid-19 immunization. Medical history included chronic pain, foot operation on an unknown date. There was no family history relevant to adverse event. There was no adverse event prior vaccination. No prior vaccinations (within 4 weeks). No vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient's concomitant medications were not reported. The patient previously took fentanyl and oxycodone. The patient was also given Dilaudid during the foot surgery. Patient stated she was a patient who has been on fentanyl and oxycodone for a couple years. She stated she recently had been in the hospital for surgery, and she was given Dilaudid and didn't bother her one bit. She stated medicine doesn't affect her, she got chronic pain. Patient stated within 3 or 4 hours, she was out of it, she couldn't get off the couch, she couldn't watch a movie. She stated if she wouldn't have come straight home, she wouldn't have been able to drive, she would have been in an accident. She stated she hated to imagine if she wouldn't have come home, they would have had to take her to the hospital. She stated it lasted for about 3 to 4 hours, she doesn't know what to say, she doesn't get high like that. Medical history was reported as she stated she was under the care of a gastro doctor. She stated she was having some problems, they were running a lot of tests, but that doesn't have anything to do with this. She states she had to have surgery recently, she wasn't walking at the time of the test, she was on wheels. She stated she had foot surgery, so she wasn't walking she was on a three wheeler and again if she wasn't home and was out when this happened, it would have been bad. She stated now, she's walking in a boot. She stated she was in a boot and a three-wheeler when it happened. She stated things turned out okay, she was high in her house safely. On 17May2021, 45minutes after getting the vaccination the patient felt so high that she was out of her mind, as if she had been somewhere it would have been horrible. The reporter reported that it was not like the patient slowly came down. The patient felt like she was higher than a kite then she was okay, and she thought what the heck happened to her. The patient did not had a hangover. Patient stated it was like it hit her, boom, then went away. Reporter stated that afternoon patient was okay, the next day she was okay. It was like something hit her, she had a reaction, and then she was okay. The patient mentioned it wasn't bad later on, wasn't bad the next day and she's fine now. There was no relevant test. No emergency and physician office visit. The outcome of the event was reported as recovered on 17May2021. Follow-up attempts are needed. Further information is expected.
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| 67 | 2021-06-03 | insomnia |
Body aches, after both vaccines; Very tired after both vaccines; Headache after first vaccine; Left ...
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Body aches, after both vaccines; Very tired after both vaccines; Headache after first vaccine; Left arm soreness, after both vaccines; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Could not sleep on left side, after both vaccines; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for Injection Batch/Lot Number: EW0172), via an unspecified route of administration, administered in arm left on 03May2021 15:30 (at the age of 67-year-old), as single dose for COVID-19 immunisation. Medical history included covid-19 from an unspecified date in Jan2021. The patient concomitant medications were not reported. On 03May2021, the patient experienced left arm soreness, after both vaccines, swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. caller reports these events together, could not sleep on left side, after both vaccines, on 04May2021 body aches, after both vaccines, very tired after both vaccines, headache after first vaccine. Patient was not administered with Additional Vaccines on Same Date of the Pfizer Suspect. The patient under-went lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Out-come of the events Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together, Left arm soreness, after both vaccines was resolved on an unspecified date in 2021, Headache after first vaccine was resolved on 04May2021, Body aches, after both vaccines, very tired after both vaccines was resolved on 24May2021, could not sleep on left side, after both vaccines was resolved on 26May2021. Agency Communication: Multiple reclarifications made with patient in adverse event section, to clarify if events occurred after the first or second vaccine, or with both vaccines. For events occurring with both vaccines, patient reports start date as when event occurred after first vaccine and end date, as the date event ended after the second vaccine.
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| 67 | 2021-06-03 | sleep disorder |
Soreness at injection spot; chills; pains and achy; muscle spasm in right lower quadrant underneath ...
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Soreness at injection spot; chills; pains and achy; muscle spasm in right lower quadrant underneath rib cage; fatigue; sleeping; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 05Mar2021 at 16:15 pm (age at vaccination was 67 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had known allergy to bee stings. On 06Mar2021 at 00:00 am, the patient experienced soreness at injection spot, chills, pains and achy, muscle spasm in right lower quadrant underneath rib cage, fatigue and sleeping. The facility where the most recent COVID-19 vaccine was administered was other (Residential Community). The patient did not receive any other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of events was resolving. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
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| 67 | 2021-06-04 | sleep disorder |
Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, aft...
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Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, after second vaccine:; Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, after second vaccine:; Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, after second vaccine:; Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, after second vaccine:; Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, after second vaccine:; Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, after second vaccine:; Sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision, after second vaccine:; Left arm soreness, after both vaccines; redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Could not sleep on left side, after both vaccines; Body aches, after both vaccines; Very tired after both vaccines; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection and Lot Number: EW0179) via an unspecified route of administration at Arm Left on 24May2021 15:30 single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, via an unspecified route of administration at Arm Left on 03May2021 15:30 single dose for covid-19 immunisation and experienced Left arm soreness, after both vaccines, Swelling of arm, itching, and redness at injection site, left arm, first vaccine, Swelling of arm, itching, and redness at injection site, left arm, first vaccine Swelling of arm, itching, and redness at injection site, left arm, first vaccine, Could not sleep on left side, after both vaccines, Very tired after both vaccines, Headache after first vaccine and Body aches, after both vaccines. On an unknown date May2021, left arm soreness, after both vaccines, redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine, could not sleep on left side, body aches, after both vaccines, very tired, on 25May2021 07:00 sinus cold symptoms: runny nose, sore throat, some coughing, hoarseness of voice, blurry vision. Patient did not visit emergency room or physician office due to events. The patient underwent lab tests and procedures which included COVID-19 was positive on an unknown date in Jan2021. Outcome of the events left arm soreness was unknown, redness at injection site, left arm, first vaccine, and swelling and itching was recovered on an unknown date in May2021, Sleep disorder was recovered on 26May2021, generalized aching and Tiredness were recovered on 24May2021, runny nose, sore throat, some coughing, hoarseness of voice, blurry vision were recovering. Therapeutic measures were taken because of, very tired after both vaccines (fatigue). Information on Lot/Batch number is available; Further information has been requested.
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| 67 | 2021-06-05 | disturbance in attention, memory impairment |
Vertigo, memory and cognitive issues, headaches, stomach aches, fatigue, shortness of breath,difficu...
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Vertigo, memory and cognitive issues, headaches, stomach aches, fatigue, shortness of breath,difficulty with concentration
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| 67 | 2021-06-08 | feeling abnormal |
had mild foggy head; upset tummy; diarrhea; just not feeling right; This is a spontaneous report rec...
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had mild foggy head; upset tummy; diarrhea; just not feeling right; This is a spontaneous report received from a contactable consumer (Patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection and Lot Number: EN6201) via an unspecified route of administration in Arm Left on 08Feb2021 16:45 (age at vaccination: 67 years) as single dose for COVID-19 immunization. Medical history included Reiters syndrome and mild food allergy to turkey. Concomitant medications were reported as none. Patient did not received other vaccines in four weeks. Patient did not had other medications in two weeks. Patient did not had COVID prior vaccination. She was not tested for COVID post vaccination. On 09Feb2021 24 hours after receiving vaccine she had mild foggy head, upset tummy, diarrhea and just not feeling right. Lasted about 36 hours. All the events were considered as non-serious. No treatment was received for the events. The outcome of events was recovered on an unspecified date in 2021. Follow-up (24May2021): Follow-up attempts completed. No further information expected.
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| 67 | 2021-06-08 | feeling abnormal |
problems with her breathing; itching in her mouth and all over; itching in her mouth and all over; f...
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problems with her breathing; itching in her mouth and all over; itching in her mouth and all over; fine rash on her upper body; Itching; Wheezing; I feel like I have ticks and fleas all over me.; Cough; This is a spontaneous report from a contactable consumer and nurse (patient) via Medical information team. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208, Expiration date was not reported), via intramuscular in left arm on 16Mar2021 13:20 as single dose for covid-19 immunisation. Medical history included allergies to seafood, peanuts allergy, ongoing lupus, ongoing Sjogren's syndrome, asthma (Diagnosed many years ago. States it was well controlled until she had the Covid Vaccine), ongoing blood pressure high (diagnosed a long time ago; maybe in 1992), ongoing seizures (States they are well controlled and her last one was 10 years ago), restless legs and food and drug allergies. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) via unspecified route from unspecified date and ongoing at 550, two times a day for asthma, salbutamol (ALBUTEROL HFA) via unspecified route from unspecified date and ongoing at 3-4 times a day for asthma, metoprolol via unspecified route from unspecified date and ongoing at 25 mg, two times a day for hypertension, levetiracetam (KEPPRA) via unspecified route from unspecified date and ongoing at 500 mg, twice a day for seizure, diltiazem via unspecified route from unspecified date and ongoing for hypertension, clonazepam (KLONOPIN) via unspecified route from unspecified date and ongoing at 50 mg for seizures, epinephrine (EPIPEN) via unspecified route from unspecified date and ongoing for drug and food allergy and topiramate (TOPAMAX) via unspecified route from unspecified date and ongoing at 50 mg, two times a day for seizures. Patient received her first dose of the Pfizer COVID-19 vaccine. patient first had a problem with her breathing. Within a few minutes, she had itching in her mouth and all over. She had a fine rash on her upper body. She was itching and wheezing. The doctor administered the EpiPen she carries in her left thigh. 911 was also called to take her to the hospital. She was also given 50mg orally of Benadryl. She was taken to the ER and administered 2 different IV medications. She mentions she was given an IV push of salmeterol; it was like Pepcid. She clarifies further it was like a form of prednisone. She was also something else IV but she doesn't know the name of it. The caller confirms she has no NDC, Lot number or expiry date for these medications she was given at the ER and/or vaccination facility site. The caller states she is still having problems with itching. She is still really itchy. She asks, when will this stuff clear out of her system. She has been taking Benadryl to calm down. She was given the COVID-19 vaccine through her arm, so it was in her system, but the itching is still here today. She is constantly scratching. She took Benadryl and used her rescue inhaler. She has her inhaler, but she keeps itching. She clarifies her rescue inhaler is Xopenex HFA (Lot number: 180456). She is prescribed to take 2 puffs every 6 hours as needed. When probed for the Benadryl she is currently taking, she clarifies it is Equate dye-free allergy relief, 25mg (Lot number: P11756, Expiry date: Oct2021). patient states she is still itching and she "feels like there are ticks and fleas all over me". patient wants to know how long to expect the itching to last? patient also stated she would not be getting the second dose. Patient reportedly received her covid vaccine and 20 minutes after experienced shortness of breath, cough, wheezing, rash and itching which is still ongoing 1 month later. The consumer further stated that she still has itching on her arms and back. HCP and the safety team is authorized to contact the HCP. Atarax, strength unknown, was prescribed for treatment of the adverse events. The outcome of the event feeling abnormal, itching all over, Itching mouth was unknown while remaining events was not recovered.
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| 67 | 2021-06-08 | excessive sleepiness |
Extremely tired slept 12 hours straight; Extremely tired slept 12 hours straight; very sore arm; wea...
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Extremely tired slept 12 hours straight; Extremely tired slept 12 hours straight; very sore arm; weakness; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 10:00 as single dose for covid-19 immunization at Pharmacy or Drug Store. Medical history included known allergies which is not specified. Concomitant medications included metoprolol (METOPROLOL) 50 MG twice a day and amlodipine besylate (AMLODIPINE BESYLATE). Patient did not have covid prior vaccination. Patient was not covid tested post vaccination. Patient did not have other vaccine in four weeks. On 08Mar2021 15:00, the patient experienced Extremely tired slept12 hours straight, very sore arm, weakness, and muscle aches. Treatment was not received for adverse events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-06-09 | excessive sleepiness |
headache; nausea; vomiting; dizziness; body aches; tiredness; stomach cramps; diarrhea; sleeping lon...
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headache; nausea; vomiting; dizziness; body aches; tiredness; stomach cramps; diarrhea; sleeping long; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: bn6198, Expiration date: unknown) dose 1 via an unspecified route of administration administered in left arm on 03Mar2021 12:30 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus from an unknown date, high blood pressure from an unknown date, bell's palsy from an unknown date, brain tumor from an unknown date. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR), rosuvastatin (ROSUVASTATIN) pioglitazone hydrochloride (ACTOS) taken for an unspecified indication, start and stop date were not reported. patient experienced allergies to sulfur. No covid prior vaccination and no covid tested post vaccination. No other vaccine in four weeks. On 05Mar2021 the patient experienced headache, nausea, vomiting, dizziness, body aches, tiredness, stomach cramps, diarrhea, sleeping long. No treatment taken for adverse events. Outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
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| 68 | 2021-01-11 | impaired work ability |
developed fever, aches, chills in the middle of the night after receiving the vaccine. did not repo...
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developed fever, aches, chills in the middle of the night after receiving the vaccine. did not report to work the following day
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| 68 | 2021-01-13 | confusional state | 1) Ice cold toes & feet, sweat in toe area of socks 2) confusion, 3) chills |
| 68 | 2021-01-13 | feeling abnormal, anxiety |
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metal...
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Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes. After that amount of time, I felt better and safe to leave the hospital. Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea. No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow. Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
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| 68 | 2021-01-16 | feeling abnormal |
chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 ...
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chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 days-this felt similar to how I felt when I had Covid 19 March-April.
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| 68 | 2021-01-19 | nervousness |
20 minutes after injection , middle finger right hand started jumping for approximately 10 minutes,...
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20 minutes after injection , middle finger right hand started jumping for approximately 10 minutes, getting less vigorous with time. 1-10-21 stared having tremors every 2-3 minutes in both hands, left leg and occasionally in right leg. Left leg and bottom of left foot numb feeling off and on.
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| 68 | 2021-01-21 | feeling abnormal |
I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightnes...
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I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightness. I say I was fine until 3-4 hours later, I had extreme headaches. At 430pm, I still had the headaches and I took Tylenol 500mg. At night my headache got worse and it felt like I had the flu. I then went to bed and when I woke up my left arm felt intense like hornets and it was swollen. I then took another Tylenol and Ibuprofen 600mg. At 4am, I felt awful and horrible. I had joint pain with aches, felt nauseated. I called my PCP and he told me to take Prednisone 10mg. My fever was 101.4F. By the night my fever was gradually coming down and it was 102F. By the next day I felt much better. I also had Covid-19 on March 2020 and also got tested for antibody test in July 2020. I spoke with my PCP and he is recommending I do not take the 2nd dose injection.
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| 68 | 2021-01-21 | nervousness |
Felt shaky, started to have facial swelling and tongue swelling and had to take diphenhydramine. St...
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Felt shaky, started to have facial swelling and tongue swelling and had to take diphenhydramine. Started to feel abdominal and chest tightness. Taken to ER and given IV diphenhydramine and IV dexamethasone
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| 68 | 2021-01-22 | anxiety |
Patient became short of breath and had to take inhaler Patient states she was anxious about getting ...
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Patient became short of breath and had to take inhaler Patient states she was anxious about getting the vaccine and had not taken her morning inhaled dose before getting her vaccine Released home without any further complaints Vital signs- 97/45, 122, 24, 99% Vital Signs- 126/74, 103, 18, 99%
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| 68 | 2021-01-22 | feeling abnormal |
30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudde...
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30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudden felt weak, lightheaded, trembly, with chest tightness and a need to lay down. The biggest problem was that my eyes became strangely affected, like there were shutters being opened and closed in rhythmic waves inside my eyes. They were also very photosensitive and blurry. My whole head felt wrong. drove me home, (I could not have driven). This lasted several hours. I had chills and stayed laying down with my eyes closed. By the end of the day I felt mostly recovered. This series of events recurred 6 days later, on Jan. 20th. This time it also lasted most of the day, but I continued feeling moderately unwell the next day, and today it continues. I feel weak and unsteady. My eyes are better but not entirely. They ache and feel insecure. I am not currently feeling up to any activities besides resting.
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| 68 | 2021-01-23 | anxiety |
Patient received her vaccination around 730 am on her left deltoid. Patient approached the observer ...
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Patient received her vaccination around 730 am on her left deltoid. Patient approached the observer around 735 am about concern of dizziness. Patient also states that she has cancer. Patient was then escorted to the bed stretcher. Patient vital signs were taken in which her BP was 181/91, O2 sat 79%, HR: 104. Patient was also noted to be anxious and states that she does not take any oxygen at home. Patient was encouraged to relax and lay down comfortably on the bed stretcher. Patient was cold upon touch. There was an attempt to warm the patient but the patient was still cold upon touch. Vital signs were taken again in which her BP was 179/84, O2 sat fluctuating between 80-90's. The decision was then made to take the patient to the emergency department.
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| 68 | 2021-01-25 | feeling abnormal |
About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hur...
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About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hurt to lift my arm. Also had some slight nausea and headache. Took Ibuprofen helped some. Next day still felt off, arm still extremely sore, body aches, headache, fatigue. I continued with the Ibuprofen alternating with Tylenol. Finally felt better by Sunday and was able to return to work on Monday.
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| 68 | 2021-01-25 | impaired work ability |
Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept thro...
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Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept through the night and awake in am without symptoms. Getting out of bed sudden drop in BP with weakness, feeling faint, nausea, sweating. Drop in BP to 68/52. Unable to go to work. Improved with upright resting in am with BP at 10:30 am 119/69 (low as my usual BP averages 130's/mid 80's). Still slightly nauseous. Able to have toast and tea. Felt better as am progressed and able to drive to work at 11:45 am. Worked until 6 pm without further symptoms.
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| 68 | 2021-01-26 | anxiety |
.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No ...
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.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No outward sign. Symptoms continued throughout the rest of the day. Mild headache, some nausea. No difficulty breathing, no fever, no hives or rash. General uneasy feeling. Next morning awoke with "fullness "in ears, with some ringing. Facial symptoms would come and go. On Sunday, two days after vaccine, I felt much better, facial symptoms better, ears still felt plugged. Could ear fine. On Monday , symptoms pretty much gone. I was in contact with primary physician through email/phone message. No treatment was necessary.
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| 68 | 2021-01-27 | disorientation | Debilitating headache, nausea, chills, aches, pains, light-headed, disorientation, diarrhea, more |
| 68 | 2021-01-27 | nervousness |
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio...
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Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-01-28 | anxiety |
2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing...
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2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing and my pressure started going up. After 3-4 days, my hairline started receding slightly on the sides of my scalp in the front. This continued each day and I had to increase my blood pressure medicine and double the dose because it was getting so high. I was anxious and upset and am afraid to take the second dose because I feel that I will get a worse reaction, and am frightened.
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| 68 | 2021-01-28 | poor quality sleep, irritability |
On the two hour ride home, my arm would ache then be fine. I was cranky, not myself, going to bed, ...
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On the two hour ride home, my arm would ache then be fine. I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm. When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything. As the day went on I was just mad about everything, I began to drink lots of water and tried to exercise to get the swelling down. About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable then. I am still swollen and still angry and it is Friday.
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| 68 | 2021-01-31 | loss of personal independence in daily activities |
PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT L...
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PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT LIFT OR USE A SPATULA TO EVEN TURN EGGS OVER IN FRYING PAN. STARTED ON SUNDAY 1/24/21 3 DAYS AFTER RECEIVING FIRST DOSE OF VACCINE. PAIN MINIMAL AT INJECTION SITE, BUT PAIN ALSO OCCURS IN SHOULDER. UNABLE TO RAISE ARM ABOVE HEAD OR EVEN STRAIGHT OUT. WAS SEEN IN URGENT CARE. PROVIDER REPORTS NO SIGNS OF PROBLEMS AT INJECTION SITE. NO REDNESS, NO SWELLING, NO NECROTIC TISSUE.
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| 68 | 2021-01-31 | sleep disorder |
About 6 hours after receiving the shot, I began to have severe lower back pain (9 pm). By Midnight...
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About 6 hours after receiving the shot, I began to have severe lower back pain (9 pm). By Midnight, I had excruciating nerve pain shooting across my lower back along with the muscular back pain. I was up all night in pain. I did not take anything for the pain for fear of comprising the vaccine. the next day pain was worse, called my doctor and was told I could take Tramadol, 50 mg. It did nothing for the pain until I took another dose. Pain got worse and I was unable to get myself out of bed, or from a sitting position without my husband pulling me up. My muscles were not working, or it was just too painful, I'm not sure. Could barely walk. This lasted for 3 full days and then the pain gradually started to subside. Took a full week for back pain to totally go away.
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| 68 | 2021-02-01 | feeling abnormal |
Was exposed to a COVID + person on the 12/20/2020, took a COVID test on 12/23/2020 negative results,...
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Was exposed to a COVID + person on the 12/20/2020, took a COVID test on 12/23/2020 negative results, on 12/26/2020 started feeling feverish at night, just did not feel good, felt tired, felt different. Then the next day started developing a cough in the afternoon, no fever during the day, took my temperature and it was 99.8F and it was later on the afternoon. On the 27th I started coughing a lot more, it kinda hurt a little bit like Bronchitis, not productive at all, I coughed a lot. Did not feel bad at all but the cough was very present. On Tuesday evening it felt like I was coming down with a cold and Wednesday my taste buds started changing, I could not taste as well and then my cough got better. Just had a stuffy nose like a cold, I was feeling fine, was able to do all my normal activities as usual. It might have lasted overall 7 days and I was completely fine.
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| 68 | 2021-02-02 | anxiety |
Following the Pfizer BionTech Covid 19 EUA, the Patient complained of rash on arms bilaterally, some...
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Following the Pfizer BionTech Covid 19 EUA, the Patient complained of rash on arms bilaterally, some anxiety related to rash. Vital signs: 11:05 am BP 148/78 HR, 11:10 am 117/79 HR 69, 11:15am BP 129/80 HR 75, Benadryl exlir 12.5mg/5mL administered at 11:15am PO. Vital signs: 11:20am BP 133/79 HR 67, 11:30 amBP 124/76 HR 63 Symptons of rash disappered at 11:30am. Vital signs: 11:45am BP 116/77 HR 63 ). Oxygen saturation stayed at 97 -99% the entire time. Patient reported felling fine. Pateint was released to home at 11:45 with spouse driving car.Pt told to follow up with ER or PCP if symptons reoccur.
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| 68 | 2021-02-03 | feeling abnormal |
Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimm...
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Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
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| 68 | 2021-02-04 | anxiety |
Within 10-minutes of vaccination, the patient reported feeling lightheaded. EMS assess the patient o...
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Within 10-minutes of vaccination, the patient reported feeling lightheaded. EMS assess the patient on-site and they were found to be hypertensive (152/88). No PMHx of HTN. Patient was anxious during evaluation. Their 12-leade EKG and other vitals were WNL. Patient's BP decreased (140/66) during the evaluation and refused transport to a hospital. Patient appeared improved and was in proper decision making capacity.
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| 68 | 2021-02-06 | restlessness |
Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever ...
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Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever (high of 101), chills, pounding headache, body aches, vomiting, diarrea. I felt incredibly tired and slept, restlessly, on and off for 24 hours. I was unable to even drink anything for about the first 15 hours. Finally I was able to eat two crackers and tea and take tylenol which took the edge off the headache. All of these sympoms persisted for 36 hours. It was miserable and I honestly have never felt so sick. That is coming from someone who has been through labor, childbirth, c- sections, and several major surgeries. I don't think I could do another vaccine without being supervised in a health care facility to help manage the side effects for the first few days. Also, I had a mild case of Covid beginning November 9, 2020 that lasted about 2 weeks. I was only exposed to one person who had covid that I am aware of. When I was with that person for about 15 minutes, we were masked and 6 feet apart. I do not go anywhere but work and am always masked, as is everone else I work with and we are always at least 6 feet apart.
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| 68 | 2021-02-07 | depression |
Patient was found unresponsive on 2/5/2021. Brought immediately to Emergency department due to respi...
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Patient was found unresponsive on 2/5/2021. Brought immediately to Emergency department due to respiratory depression/distress. At this time it is unclear etiology of presentation. However patient is slowly becoming more alert/awake.
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| 68 | 2021-02-07 | feeling abnormal |
Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ...
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Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion. Felt extremely weak in the evening.
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| 68 | 2021-02-10 | fear |
left face and ear were red and hot; left face and ear were red and hot; She got scared; side where t...
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left face and ear were red and hot; left face and ear were red and hot; She got scared; side where the injection was given on her face felt like NOVOCAINE wearing out after the dentist/left side of the face cheeks to eye felt numb tingling, it felt different/like it was numb but not numb; left side of the face cheeks to eye felt numb tingling, it felt different; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EZ9262), via an unspecified route of administration in the left arm on 25Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history included high cholesterol diagnosed a few years ago. Concomitant medication included atorvastatin for high cholesterol. The patient took the vaccine yesterday (25Jan2021) and the side where the injection was given on her face felt like procaine hydrochloride (NOVOCAINE) wearing out after the dentist and she doesn't see this listed on the sheet given. The left side of the face cheeks to eye felt numb tingling, it felt different. She wants to know if it's normal. She got the shot at 25Jan2021 10:00 and by 25Jan2021 17:00, her left face and ear were red and hot. Then, she felt her face. It felt like procaine hydrochloride wearing out after the dentist, like it was numb but not numb. She got scared and got up and looked at herself to see how it looked and there was no change. She scratched both sides of her face and they felt the same. It continued all night. This morning (26Jan2021), she thought it went away but she felt it all over again, not as much. She is not burning up, not like yesterday. She did not take her temperature; she should have to see if she had a low grade fever. Outcome of the event "she was scared" was unknown while of the remaining events was recovering.
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| 68 | 2021-02-11 | feeling abnormal |
Fever chills, body aches cough .I felt really bad and could not move out of bed . All symptoms laste...
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Fever chills, body aches cough .I felt really bad and could not move out of bed . All symptoms lasted 4 days My fever was 101.5
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| 68 | 2021-02-13 | insomnia |
Approximately 2:30 am I awakened from sleep with difficulty breathing and a stuffy nose. Similar to...
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Approximately 2:30 am I awakened from sleep with difficulty breathing and a stuffy nose. Similar to a common cold, but with the breathing issue. I contacted Dr on Demand to ask if it was ok to take medication. This was ok and as I would normally at the onset of a cold with these symptoms I took one Mucinex and used one inhalation of BREO. After about 30 minutes I felt better and was able to sleep. I woke up approximately 8 am and had symptoms of a common cold, no breathing issues. I did not repeat the BREO. However at 10PM that night I took another Mucinex for a stuffed nose. On Feb 14 I took a Mucinex at 10 am. as the day progressed the stuff nose lessened.
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| 68 | 2021-02-14 | feeling abnormal | infection site pain, tiredness, headache, chills, joint pain, fever, foggy thinking, feeling unwell |
| 68 | 2021-02-15 | sleep disorder, restlessness |
After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days aft...
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After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days after I had itching, prickly tingly sensations everywhere, especially arms, legs, neck, and back. These lasted for 11 days after that, finally subsided. But then I got dose 2, and had sore arm, and next day, aches in muscles, low fever, congestion but all mild. Took ibuprofen and went away after 24 hours. 5 days later, the itching, tingling started up again and was more intense and everywhere. Have had some redness, swelling, red bumps in itchy areas, they come and go. Worse when I have hot flash. Itching is keeping me awake along with anxiety and restlessness. Hope this won't last for another 10 days, very uncomfortable.
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| 68 | 2021-02-16 | insomnia |
lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pa...
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lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pain; Her husband had to pull her out of the bed because she felt she had no muscle activity; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EL8982), via an unspecified route of administration in the left arm on 17Jan2021 at 15:00 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included benign spinal cord tumor from 1987 and unspecified if ongoing (a lot of bone had to get cut), lot of scar tissue (wonders if it is a weak spot) from an unspecified date and unspecified if ongoing, thyroid removed in 2015, neurosurgery (to remove the benign spinal cord tumor) on an unspecified date, thyroid on an unspecified date and unspecified if ongoing and cholesterol from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing levothyroxine (strength: 125 ug) taken for an unspecified indication at 125 ug, 1x/day, ongoing pravastatin (strength: 40mg) taken for cholesterol from an unspecified date at 40mg, 1x/day and ongoing multivitamin. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID-19 vaccine. The patient experienced lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity, all on 17Jan2021. The patient called and stated "she had a very extreme reaction from the first dose of the vaccine, which she had last Sunday the 17th. It began with lower back pain, which did not alarm her too much but then it went in to nerve pain. By the end of the evening, by about midnight, she was in what she considered to be excruciating pain. She changed positions and it was hitting the nerve and she was getting pain and having muscle pain. She was up all night because she could not sleep with the pain. Monday and Tuesday were very excruciating, and she took Tramadol Monday after consulting with her doctor. She did not get any relief until Wednesday, 3 days after the shot. Even today she had some lower back pain, but it is way better than it was. It was improving from Wednesday to today but Sunday to Wednesday was excruciating since it was giving her nerve pain. Her husband had to pull her out of the bed because she felt she had no muscle activity. In 1987 she had a spinal cord tumor and a lot of bone had to get cut and she stated she was sure she had a lot of scar tissue and wondered if it was a weak spot. She stated this could be an isolated incident, but she really thought she had another tumor at first until it started dissipating on its own. She stated she did not know anyone who has had this reaction and asked if it was safe/advisable to get the second shot? She stated she was afraid of the permanent nerve damage but as long as it cannot do anything permanent, she wanted to get it. Was this a reported symptom? Has anyone ever gotten paralyzed? After verbal response she stated she will talk with her doctor and maybe see a neurologist." Upon follow-up the patient called and stated "I had two questions actually. I received the Pfizer Vaccine yesterday and last night I started with the excruciating back pain, my lower back. I do not know if it was coincidence or not because I have back trouble before. I did not do anything to throw my back out. However, I was told it would be okay to take Extra Strength Tylenol. I took 4 Tylenol within like 3 hours period because it was not working. I took another two this morning. Tylenol was not doing anything at all for the pain relief. My question was, I have a prescription of Tramadol which I took for pain for different reason, but I have it. First of all, I hope by taking the Tylenol yesterday that it did not interfere with the efficiency of the vaccine. My other question is can I take the Tramadol now? Since the vaccine was 24 hours ago would it interfere with efficiency?" Upon follow-up the patient called to report that "she went to her chiropractor late Wednesday afternoon, and he did some stretching, but her spine was not out of alignment, so he felt her pain was due to the vaccine. Stated that it was not until her back started getting better on Wednesday without treatment that she first started to attribute it to the vaccine, because her back just did not get better on its own. Stated that the first day she did not take anything for the pain because she was worried that it might interact with the vaccine or its effectiveness, but the next day she began taking Tramadol pain meds that she already had in the house for her knee. Stated that the pain in her back was so bad, that even a strong medication like the Tramadol did not take away the pain. It did not help all that much, she had to take a 2nd 50mg tablet 3 hours later. Should she get the second dose of the vaccine? Could it possibly do more nerve damage; could she be jeopardizing her nervous system? Have there been any other reports about this? Stated that other people had minor things like, one person reported being tired for a couple days, and another person reported body aches like with the flu, but after 3 days they both were fine. Her husband was 74 and had the vaccine and he had no side effects." The events prompted a visit to her physician. The patient stated that "this was the first day since Sunday that she was feeling almost 100%. She had the pain from Sunday evening all the way until noon on Wednesday; at that point it improved about 50% and she had some mobility." The outcomes of the events lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity were all recovering/resolving.
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| 68 | 2021-02-19 | sensation of foreign body |
Some difficulty in swallowing, a feeling of lump in the throat, unable to swallow one time. Lasted...
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Some difficulty in swallowing, a feeling of lump in the throat, unable to swallow one time. Lasted a few hours. Fatigue for 24 hours.
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| 68 | 2021-02-20 | sensation of foreign body |
Some tightening of the throat (lump). Lasted a couple of hours. Affected swallowing. Fatigue, head...
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Some tightening of the throat (lump). Lasted a couple of hours. Affected swallowing. Fatigue, headache, fever, sore arm for 24 hours. Fatigue, headache still continuing 36 hours later after injection.
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| 68 | 2021-02-21 | impaired work ability |
That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning...
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That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning went to work and then around 9:30 the chills started, checked my temp 99.8 decided to take myself home, at took temp again, 101.7 then an hour later 102.7 where it remained for the rest of 2/18/21. By the next morning no more chills and temp 97.6. I do have a lingering headache on both sides of my head which meanders down my neck. The site of the injection is still sore and seems to have moved 3 inches down my arm. And there is also a lingering phlegm problem building up at the back of my throat.
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| 68 | 2021-02-22 | anxiety |
Reported that she experienced slight blurry vision. Moved to observation chair- BP 124/76 pulse 72. ...
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Reported that she experienced slight blurry vision. Moved to observation chair- BP 124/76 pulse 72. Had 5 oz bottle of water. Reports that she has had high blood pressure. After 5 minutes- vision no longer blurry. Reported that she believe she was anxious.
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| 68 | 2021-02-22 | confusional state | Dizziness, weakness, sweating, confusion,stumbling when trying to walk. |
| 68 | 2021-02-26 | anxiety | Anxiety and Pyrexia . Negative all other symptoms. Pt held for observation and provider released |
| 68 | 2021-02-27 | feeling abnormal, memory impairment |
First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects wer...
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First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects were very different. Received the shot around noon on Tuesday , February 23, 2021. Later in the afternoon experienced muscle aches and chills. My head felt kind of weird. Hard to describe except I once had a morphine shot that made me feel close. I spent the next ~60 hours in bed. Fever, severe joint and muscle pain, migraine like headache, and brain fog is about all I remember. It could have been 2 hours or 60 hours, I don't remember. On Wednesday and Thursday my sedentary heart rate was 101 and 95 according to my Apple watch up from 77 on Tuesday. Couldn?t eat. Food tasted and smelled differently but not in a good way. Woke up this morning,Friday, with a mild headache and very fatigued but mostly back to normal.
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| 68 | 2021-03-01 | sleep disorder |
soreness @ injection site initiated 2 hours later & persisted for days: fatigue & sleepiness initia...
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soreness @ injection site initiated 2 hours later & persisted for days: fatigue & sleepiness initiated after 2 hours & persisted for days after 16 hours of sleep; dull headache at base of skull initiated after 4 hours & dissipated after 48 hours.
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| 68 | 2021-03-02 | anxiety |
3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face...
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3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face, and then some "rubbery" weakness in my arms and legs. Treated in an ambulance at vaccine site with IV Benadryl, had some skin tingling, also given IV solumedrol and observed for almost 2 hours with no other symptoms. I was also hypertensive, probably due to anxiety.
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| 68 | 2021-03-02 | anxiety |
Palpitations, anxiety, and dizziness. BP 144/76 (pulse 66), and stabilized after receiving albuterol...
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Palpitations, anxiety, and dizziness. BP 144/76 (pulse 66), and stabilized after receiving albuterol.
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| 68 | 2021-03-02 | anxiety |
Pt. at the observation site felt difficulty breathing and anxious. Paramedics assessed pt. Once p...
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Pt. at the observation site felt difficulty breathing and anxious. Paramedics assessed pt. Once pt. symptoms subsided she was released by paramedics to leave.
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| 68 | 2021-03-02 | insomnia, anxiety | Severe headache, extremely high blood pressure 220/120, low blood sugar, anxiety, insomnia |
| 68 | 2021-03-02 | sleep disorder |
Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where ...
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Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where I have issues now and then). It is bothersome to the point that I cannot find a comfortable position to relieve the pain. It feels like my lower body is being seized up, so to speak. The only way I can sleep is to take 2 Aleeve PM tablets. I take regular Aleeve throughout the day to take the edge off the pain. The reason I suspect it is a side effect is that a year ago I took the new Shingles 2-dose vaccination. I had this same reaction after taking the first dose - and it occurred about 2 weeks after that shot.
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| 68 | 2021-03-03 | memory impairment, feeling abnormal, confusional state |
she is having confusion and dementia,; went into this kind of like dementia-like state where she tal...
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she is having confusion and dementia,; went into this kind of like dementia-like state where she talked incessantly/ she is having confusion and dementia,; She had days of vomiting and nausea; She had days of vomiting and nausea; She complained of brain fog and couldn't focus on the tv or her programs; kidney functions were not good enough; she has mood swings; she could not remember or know everything from the present; she had a UTI; This is a spontaneous report from a contactable consumer (patient's sister). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular injection on 20Jan2021 (at the age of 68-year-old) at single dose for COVID-19 immunisation. Medical history included ongoing breast cancer stage IV, patient was in treatment for breast cancer stage IV, she had cancer 13 years prior the report in 2008, and then was found again and diagnosed 3 years prior the report, in Jun2018; chronic obstructive pulmonary disease (COPD), a long time, a lot of her adult life. The patient was on oxygen; she had a lot of fluid built up from the cancer; patient tested positive for COVID in 2020 (Feb2020 or Mar2020, as reported). She and her roommate tested positive and had a cough. They had no fever or other symptoms. Both in the nursing home got over the cough and 21 days later tested negative. Patient tested negative for COVID ever since. The nursing home tested the residents and staff every week. They had tested the patient so much to the point her nose was bloody which the reporter got upset about; hallucinations and paranoid thoughts. Concomitant medications included ongoing perphenazine (TRILAFON) taken for hallucinations and paranoid thoughts; treatment for breast cancer stage IV and oxygen. The patient lived in nursing facility and had received both Pfizer vaccine doses. The patient received the first vaccine for COVID-19 immunisation in Dec2020. She was fine. She got the second one on 20Jan2021. Since patient received the 2nd vaccine dose, in Jan2021, she was having confusion and dementia, which was not an issue before the vaccine doses. The patient was having trouble putting words together. Patient initially had vomiting, nausea and brain fog where she could not concentrate on her TV, in Jan2021. She was hospitalized from 17Feb2021 to 20Feb2021 to have all kinds of tests run and see if her cancer had spread to her brain. Patient had 3 years with stage 4 breast cancer and had fought so hard and was aware of her confusion and it was very upsetting to her. She had days of vomiting and nausea. She complained of brain fog and could not focus on the tv or her programs. Within days, she went into this kind of like dementia-like state where she talked incessantly and could not get a thought completed. Patient would go from one thought to the next. It was very bizarre. She had never had this kind of issues. This went on for so long, they finally put her in the hospital. Patient had stage 4 breast cancer, and the doctors thought maybe her cancer had gone to her brain. The doctor did not think it was related to the COVID-19 vaccine. She was checked for a urinary tract infection (UTI), for brain cancer, for a stoke, for everything. She saw so many doctors. She still had not come out of this a month later. She was currently on psych meds because she had mood swings, since Jan2021. It had been one thing after another. The patient could not tell the time. On some level, patient knew something was wrong. She was in a very confused state. She did not know how to tell anyone what she wanted to tell. It was very distressing to say the least. She had made a little bit of progress. She could tell time with some struggling but she got upset and cried. Patient could only tell that the time was 3, but not 3:15. But, then she cried and got upset. She had been able to tell time a couple of times, but if you asked her what day was it, she had no clue. She had no clue what day it was and would ask "what day is it?" Her moods all over the place. The patient was still very confused. The reporter explained the patient could be 5'3'', she was unsure. The reporter really did not know the patient weight, she was guessing around 270lbs. She had a lot of fluid built up from the cancer, and reporter had not seen her since COVID started. Patient told that her weight was up around 300lbs. The reporter declined to include a healthcare professional for the report, stating she had not spoken to her sister's primary care doctor. She was waiting for her to call back. The patient was sent to the ER and admitted into the hospital on 17Feb2021. She came back from the hospital on 20Feb2021 at 6:30pm. She had a CAT scan, MRI, bloodwork done, in Feb2021. She saw a psychiatrist, neurologist, her oncologist. There was so many doctors seeing her and talking to the reporter. The last doctor the patient saw in the hospital said that she thought the patient was dehydrated from her vomiting episodes, but did not know for sure. In Feb2021, the nursing home did blood tests and a urinalysis to see if she had a UTI. The blood work would have shown if patient was dehydrated and she was not. The head nurse thought it was the vaccine, but she was not sure. Everybody was not sure. No one could tell her anything concrete about patient. She was not normally like this. Patient had recovered completely from the nausea and vomiting. They tried for a while to give her an anti-nausea medicine, but she could not keep anything down. It was given to her orally, she did not know why an injection was not given. This lasted for a few days, clarified as maybe 3 days. The reporter had no name, NDC, lot number or expiry date for the anti-nausea medicine the patient took. She knew it was given to her once and when they tried to give it to her again, patient refused. Reporter had no product information to provide for the first and second doses of the COVID-19 vaccine, did not have the patient vaccine record card. This would be with the nursing facility. She mentioned patient went into the nursing home on Jan2018 and then was diagnosed with breast cancer Jun2018. She did not know if there were any interactions there with the patient having the breast cancer and receiving the COVID-19 vaccine. The reporter had no product information for the first dose. When probed for the date in which the first dose was given, she explained she was sent constant emails which could have provided a date, but she did not know this information offhand. It was approximately a month before the second dose, or it could have been on 27Dec2020, which was a little closer than a month apart. No additional vaccines were administered on the same date of the Pfizer vaccine. The events required a visit to emergency room. Patient had constant testing while in the hospital. In the hospital, in Feb2021, they did MRI and CAT scan to see if the breast cancer had gone to the brain and both were negative. They tested for UTI. They did the first UTI test at nursing home in 2021 and they said she had a UTI and patient was put on an antibiotic. They tested her again for a UTI when she was admitted into the hospital in Feb2021 and they said she did not have a UTI. She did have a buildup of urine in her bladder because her kidney functions were not good enough for the MRI at first, in Feb2021. Her bladder was relieved of the urine build up and her kidney functions improved and she was able to get the MRI. The MRI did not show any cancer in the brain. None of it relieved her symptoms. This was just bizarre. It happened within a week of receiving the vaccine. She could not talk with patient and patient had never been like that. The patient had always been lucid and open and you could talk about anything: the past, the present, she had no problems. She could remember everything crystal clear from the past but she could not remember or know everything from the present. The reporter would ask her what day was it and the patient did not know. The patient would absorb the information she was told but there was like this strange disconnect, almost like a dementia of some form. About concomitant medications, the reporter explained the patient had not started anything new. She had been on the same stuff for many years. She had psych meds that she had been on, but she had been on those for many years. She clarified further that patient had been stable on her psych meds for many years, and the nursing facility had the patient stable for 3 years at the nursing home. At the time of the report, her mood swings were all over the place, she had never had that before. She had hallucinations and paranoid thoughts in the past, but she had never had mood swings like this and never had dementia. She had been on the same medications for a long time, but they were currently trying to play with them and trying to adjust her psych meds. It was apparent it was not working and this was something more organic, something going on in her body. The psych med was perphenazine all of her life. The psych nurse was a new nurse and was not familiar with the patient. The psych nurse informed the reporter she raised the perphenazine to the highest dose she could possible go on and told she could have to try the patient on a mood stabilizer and could have to put her in a psych unit. The reporter would not have any NDC, lot numbers or expiration dates, or anything like that. The reporter had been told an UTI could have caused the patient symptoms. It could have been brain cancer, or this or that. She did not know what was going on. Reporter asked if there had been any reports or had other people called in with these types of reactions or adverse events. The patient had recovered from vomiting and nausea on an unknown date in 2021, had recovered from kidney functions were not good enough and UTI in Feb2021, the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-03-04 | feeling abnormal |
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pres...
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week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
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| 68 | 2021-03-04 | mental status changes |
found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the...
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found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the ER- fever 101.2, HR elevated, decreased BP
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| 68 | 2021-03-04 | nightmare, restlessness, crying |
6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint ...
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6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint pain and stiffness., muscle soreness. Noticed voice hoarseness. Attempted to sleep after taking Advil with nightmares and restlessness. Felt this overall feeling of crying and uncontrolled sobbing. I had COVID in May of 2020 with hospitalization, Remdesivir IV. Pneumonia . July I was feeling better with noted Shortness of Breath not brought on by activity. I was able to resume my exercise activity. I walked but no longer able to walk 3-4 miles per day. I am walking 2 miles w strengthening exercise. The headache comes and goes with the addition of Advil and Tylenol alternating takes the edge off. I take a Zyrtec but it does not help
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| 68 | 2021-03-04 | restlessness |
30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient w...
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30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient was coughing and clearing throat. Fluids were offered and patient was moved to a more private area, vitals were taken. Pulse ox 96% RA, blood pressure was elevated, HR was 86 bpm. Rapid response team was notified and took the patient to the hospital's emergency department.
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| 68 | 2021-03-05 | impaired work ability, sleep disorder |
About 12 hours after 3/4 vaccine, began to experience intense flare-up of neuropathic pain in droppe...
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About 12 hours after 3/4 vaccine, began to experience intense flare-up of neuropathic pain in dropped R foot, especially around large R toe. Went to bed. Woke up in pain around 3 am on 3/5. Drank water. Applied Castor oil and Arnica. No sound sleep rest of night. On rising, showered. Heat helped a bit. Drank more water. Applied more Castor oil and Arnica. Pulsing electrical/spasm-like pain continued in R foot, especially between big toe and 2nd toe. Though felt vaguely nauseous, ate and stayed hydrated. Could not work. Laying down and warming, elevating foot helped. Around 9 pm on 3/5, intense flare-up began to subside.
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| 68 | 2021-03-07 | anxiety |
@841 client walked 10 feet to ask a question and suddenly felt dizzy. Assisted to sit down in chair...
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@841 client walked 10 feet to ask a question and suddenly felt dizzy. Assisted to sit down in chair. Vitals obtained @0842: 90, 110/69, 99% on RA. Head-to-toe assessment completed. Patient noted to be anxious and hyperventalating. Instructed to take slow, deep breaths. Given reassurance and water to sip. Client refused to have EMS called to check here out and reported feeling better after a few minutes. Monitored for an additional 15 minutes. Client assisted to stand and walked without issues. Denied dizziness. Client walked to door and left with husband ambulating, AAOx4. NAD.
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| 68 | 2021-03-07 | insomnia |
SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT ...
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SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT MUCH. UPON WAKING DAY TWO, I HAD A VERY PRONOUNCED ACHE IN THE BACK OF LEFT SHOULDER AND THE ACTUAL SHOULDER BLADE WAS SORE AND PAINFUL TO THE TOUCH. I DID NOTHING THE FIRST DAY OF THE DISCOMFORT (THINKING IT WOULD GO AWAY). I NOW APPLY CBD/THC BALM ON THE AREA 3 TIMES A DAY AND I'VE BEEN TAKING EXTRA STRENGTH TYLENOL , TWO TABLETS, THREE TIMES A DAY. I AM SLEEPING IN A ZERO-GRAVITY MODE ON MY SLEEP NUMBER BED...OTHERWISE I CAN'T SLEEP AT ALL. I HAD A HOLE IN MY ROTATOR CUFF SURGUCIALLY REPAIRED ABOUT 18 MONTHS AGO AND THE PAIN I HAVE NOW ACTUALLY FEELS LIKE MY SHOULDER FELT BEFORE AND FOR AWHILE AFTER THE SURGERY! I AM BEGINNING TO WONDER IF THERE IS A RELATIONSHIP TO THE TWO EVENTS.
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| 68 | 2021-03-07 | loss of personal independence in daily activities |
I had body aches and I had pain in my right wrist. After my second dose on 2/25/2021 I had pain in m...
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I had body aches and I had pain in my right wrist. After my second dose on 2/25/2021 I had pain in my left groin joint and cannot walk. 2nd dose of Pfizer received in my left arm lot#EL9266 on 2/25/2021
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| 68 | 2021-03-07 | thinking abnormal |
Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to proces...
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Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to process thoughts logically. Arm somewhat sore, but not horrible. This lasted until I went to bed Friday night at 11:00 PM
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| 68 | 2021-03-08 | disorientation | couldnt stay awake, headache, disorientation, swollen and pain at site |
| 68 | 2021-03-09 | loss of personal independence in daily activities |
11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (...
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11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (not the injection site, the whole upper arm muscle). Three weeks after the shot, my arm is still very sore and I can hardly use my left arm. It's very painful to get dressed, take off a jacket, shirt, etc. I can hardly use the left arm to hold anything due to the pain in the muscle.
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| 68 | 2021-03-10 | anxiety |
Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergen...
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Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergency room. Admitted to hospital for hospital for 1 day. Was given anti-vomiting/dizziness drugs, CT scan, IV for dehydration, pain and anxiety medicine. Diagnosis was vertigo. Upon release from hospital, consult with internist further diagnosed condition as labarynthitis. Headache and slight dizziness continued for a couple of weeks . After second dose dizziness, light-headedness and headache are significant enough to take Tylenol regularly. These effects are still in place 12 days after 2nd dose. Will see internist if symptoms continue after 2 weeks.
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| 68 | 2021-03-10 | feeling abnormal |
She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsid...
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She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsided; The extreme pain, mental fog, and disconnect that came with it has all subsided; Cytokine storm; extreme chills with teeth chattering; This is a spontaneous report from contactable consumer. A 68-year-old female patient the second dose of BNT162B2 (Batch/lot number: EN5318) on 04Feb2021 at 1:00 on Left arm for covid-19 immunization. Medical history was ongoing Arachnoiditis (this is a spinal cord disease). Concomitant drugs were not reported. Historical Vaccine was 1st dose of BNT162B2 (Lot Number: EL1283) on 15Jan2021 administered in left arm for covid-19 immunization. She was calling to report a severe reaction that occurred after the second injection. On 05Feb2021 she started to have extreme chills with teeth chattering at 3 AM. She knew this could be part of the symptoms. At 6 AM on 05Feb2021 she got up and with her husband's assessment who is also is a doctor it was determined by her husband she was in a cytokine storm that attacked her spinal cord disease. The extreme chills ended within a couple of hours on 05Feb2021. The cytokine storm has pretty much resolved. It is still there, but better. She still has fatigue. However, the extreme pain, mental fog, and disconnect that came with it has all subsided. Caller stated she knows from research and talking to other people most people might have the chills after the COVID Vaccine. The chills is not the severe side effect she is referencing as severe. The Cytokine storm reaction for her wit her spinal cord disease is unexpected and not normal. This was the severe event. No Emergency Room visited. Physician's Office visited for Cytokine Storm. She should have gone to the hospital, but she did not want to go. Seven days after event started, she went to her physician. This was as soon as she was able to get up and get out of the house. Treatment was mainly self-treating. Her husband is a doctor and they did what they needed to do at home. These side effects were pretty horrific. Outcome of the event cytokine storm was recovering, for fatigue was not recovered, for other events was recovered. No follow-up attempts are possible. No further information expected.
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| 68 | 2021-03-10 | feeling abnormal |
late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick ...
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late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick yellow bile. felt nausiated all day, "foggy" headache and lack of appetite. night sweats for 2 nights. no fever.
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| 68 | 2021-03-11 | anxiety |
Patient received vaccine at local health department clinic on 2/18 and started experiencing itching ...
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Patient received vaccine at local health department clinic on 2/18 and started experiencing itching and a rash during the monitoring period. Also complained of nausea. Patient has h/o autoimmune disorder and rosacea. Took 50mg diphenhydramine prior to arrival in this reporters facility ED. patient states very anxious about receiving vaccine. symptoms resolving discharged home from ED
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| 68 | 2021-03-11 | sleep disorder |
Sore arm began on afternoon of shot, the next day was very tired and a headache. Overnight, woke up ...
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Sore arm began on afternoon of shot, the next day was very tired and a headache. Overnight, woke up with vertigo. All symptoms went away within the next 24 hours.
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| 68 | 2021-03-12 | mental impairment |
I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed wh...
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I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed what I would describe as discomfort in the lymph system. Also, I have difficulty thinking clearly. Tasks that I usually complete easily such as online banking have been more difficult. I'm making mistakes. As I write this I am now three days from the inoculation. I have burning pain under my right arm. I have burning pain in tops of my feet. My hip joints are stiff. My eyes are sore. I feel generally fatigued. This is not my normal level of functioning.
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| 68 | 2021-03-12 | sensation of foreign body, feeling abnormal, disturbance in attention |
Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused...
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Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused room spinning and broke out in cold sweat. Severe vertigo continued through second day (Feb 22), but seemed to diminish somewhat toward evening. Day 3 still had moderate vertigo/nausea but better than previous day. Went on a long walk. Day 4 moderate vertigo/nausea continued. Tried doing Epley exercises for vertigo. Vertigo/nausea became severe again, so severe I vomited several times. After vomiting got the shakes and felt very cold. Checked blood pressure and it was very high (170/98), but pulse rate was in low 30s. After a few hours blood pressure and pulse rate became closer to normal. Almost decided to go to ER clinic, but decided to wait until my daughter came home from work because I was way too dizzy to drive. After I calmed down I decided it wasn't an emergency. Severe vertigo continued through evening of day 4. On day 4 I called primary care doctor to see if there was anything I could do for the vertigo. She prescribed meclizine, but hearing that it is an antihistamine, I declined it (antihistamines make my heart race and make me very anxious). Severe vertigo/nausea continued through day 5 and day 6. (Severe vertigo/nausea being that I could not move around at all other than to sit still staring forward without the room spinning.) All this period I also had a headache, a feeling of pressure through my whole head/sinus area, and my vision was blurred. I also felt as though I could not focus my eyes or concentration. I tried using some over-the-counter nasal decongestant spray for 2 days to relieve congestion in head, but they made me feel very anxious, so I stopped. I also tried taking some Aleve a couple of times. It helped a little, but made me feel woozy, so stopped. Day 6 the vertigo/nausea improved to moderate, but I could still not walk straight. I felt unsafe to drive. Day 7 continued to improve, but still moderate vertigo/nausea. Day 8 I noticed a lot of improvement in vertigo/nausea. Kept improving day 9. By evening on day 10 I was noticing a rawness and lump in the back of my throat. Called primary care office day 11 to see someone. Drove car, but felt marginally safe driving. Was diagnosed with a sinus infection and prescribed a 10 day course of Amoxicillin/Clavulanic Acid (875-125 mg for 2 pills a day for 10 days). Felt improvement in throat and sinus over next few days. Day 15 I felt greatly improved with head ?fog? and vertigo. Had an appointment with an ENT clinic on day 15 to see what was causing vertigo. All tests were good for hearing, and visual examination of ears. Was checked for BPV but that was ruled out. Said vertigo was probably caused by viral infection or inflammation of vestibular nerve or canals. Recommended waiting for improvement and coming back if it persisted. Began doing more normal activities even though I still had mild vertigo. Day 16 felt still better in morning, then in afternoon bent over quickly to catch something and got a terrible wave of spinning again. Moderate/severe vertigo continued that evening. Improved to moderate on day 17 and 18. All along, when vertigo was worse, so was the ?fog? (blurry vision, inability to focus mentally). At day 19 I feel like I did on day 15, but I have noticed the pressure/lump around my ear and on left side of head is improved. Brain ?fog? is improved too, very mild and the vertigo is mild. I finish my antibiotic tomorrow.At present vertigo is not gone. Its mild today, but this is only one of maybe 2 1/2 days in which its been this mild (out of almost three weeks since I was vaccinated). I have been drinking a lot of water every day, and ginger tea when I get nauseous. I had my 2nd dose of the COVID Pfizer vaccine scheduled for Mar 15. I?ve cancelled it and intend to wait to see how long it takes for vertigo to finally resolve before considering a 2nd dose.
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| 68 | 2021-03-13 | sleep disorder |
Almost immediate fatigue that lasted about 5 hours. Slight headache. Later that night while sleepi...
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Almost immediate fatigue that lasted about 5 hours. Slight headache. Later that night while sleeping I woke up and could not breathe and my chest hurt. It lasted about 15-20 minutes. I would like to know if it is safe for me to take the second dose as I have heard from friends that it was a little bit more difficult if you had side effects.
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| 68 | 2021-03-15 | fear |
afraid; lump formed at the site of the injection; Itches also; This is a spontaneous report from a c...
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afraid; lump formed at the site of the injection; Itches also; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration, in the left arm, on 09Feb2021 09:45 at a single dose (at the age of 68-years-old) for COVID-19 immunization in a public health department. The patient received the first dose of BNT162B2 (lot number: EL1283) on 19Jan2021 09:30, in the left arm (at the age of 68-years-old) for COVID-19 immunization. Medical history included asthma and known allergies with sulfa and penicillin (reported as "pennicillian"). Concomitant medications included losartan; amlodipine; potassium chloride (POTASSIUM CHLORIDE CR WM); and hydrochlorothiazide; all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had a lump formed at the site of the injection appearing the second day (11Feb2021) after injection. The lump was not going away. Itches also. The patient did not know if she should see a doctor or not. The patient wanted to know if she should take Benadryl or take pain relief. The patient was afraid. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The events were considered non-serious by the patient. The patient has not recovered from the events.
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| 68 | 2021-03-15 | feeling abnormal |
68 yo WF in excellent health with prior history of intermittent benign positional vertigo for seven ...
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68 yo WF in excellent health with prior history of intermittent benign positional vertigo for seven years and a cerebral concussion two years ago from which she recovered uneventfully in 6 weeks with no residual neurologic or physical issues. Patient received first dose 1/19/2021 with only mild fatigue and arm soreness at injection site. 16 hours after the second dose, Patient developed a dull total cranial headache and fatigue , retiring to bed , taking no medicines. She had taken only her premarin 0.625 mg for the last week. Patient awoke at 4:30 am with severe headache, nausea and vertigo, being unable to stand without assistance. urinary incontinence also occurred, but most likely occurred as she was unable to to get to the bathroom due to vertigo and pronounced vomiting of clear yellow fluid. incontinence never occurred again throughout the illness. examination at this time showed nystagmus on bilateral lateral gaze and vertical nystagmus. no other neurological signs or symptoms were present. On return to bed, Patient continued to have vertigo headache and nausea even supine with eyes closed. Vetigo and standing instability did not respond to epley manuvers. Headache remained mild to moderate, along with persistent vertigo and nystagmus for 4 days, becoming slightly less each day. On the fifth day, Patient was able to ambulate unaided by holding onto walls furniture etc. vomiting did hot reoccur after her initial bout. Headache abated on the fifth day. Patient remained "fuzzy" and imbalanced for the next 14 days with occasional mild posterior cranial headache. Rotary nystagmus abated on the 7th day. Note is made that no abnormalities of the tympanic membranes were noted. no cardiac symptoms or irregularities were noted HR 60 BP 110/70 several attempts at epley manuvers only resulted in symptom worsening. Patient felt well enough to traveled by airplane day 8 post dose, having still some "fuzziness 'and slight imbalance, being unable to walk briskly due to gait instability..symptoms worsened slighty after air flight, and on return to home, slight barotraumatic changes were noted in the tympanic membranes, slight fluid levels and some small streaky membrane hemorrhages noted. her gait became slighty more unstable, but she was able to walk unaided. symptoms improved daily and by day 14 symptoms seemed to be much lessened, no nystagmus being noted. vertigo was present only on rapidly standing , position change and vertical looking up., vertigo abating quickly after each motion at rest. Patient traveled by plane on 3/4/21-3/8/21, vertigo escalateed to mild to moderate..no response to epley manuvers. Vertigo worsened daily and Patient again developed mild gait instability and nystagmus bilaterally and vertically. Ear exam was unchanged. no headache was present during this time. Patient was taken for balance training to a specially trained Physical therapist on 3/10/21 for evaluation , Patient being markedly symptomatic, examination showing both right and left ear abnormaities as well as vertical nystagmus. driving was prohibited. The constellation of symptoms for the even are most consistent with acute vestibular neuronitis or central vertigo.. Neuologic localizing signs suggestive of cerebral thrombosis, etc were not present , so MRI was not performed. Patient had Had a Notmal CT scan with here cerebral concussion two years prior. As the symptoms weer worsening and the result of the balance training session on 3/10/21 resulted on significant worsening on awakening on 3/11/21 with moderate gait instability, bilateral horizontal and vertical nystagmus, Prednisone 40MG po was administered. Approximately 8 hours after the prednisone dose, Patient was able to stand unaided, and vertigo was almost totally cleared. 30mg prdnisone was administered on 3/12/21 with Patient being totally asymptomatic. No nystagmus could be detected and epley manuvers done by the physical therapist resulted in no symptons or evoked nystagmus. Predinsone dose was deescalated by 10 mg daily, Patient remaining totally asymptomatic. today 3/16/21 Patient will take 5mg of prednisone, still assymptomatic, prednisone to be discontinued tomorrow.
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| 68 | 2021-03-16 | disorientation, confusional state |
Pt describes getting a vaccine on 3/5, then on 3/8 woke up in the morning and was very confused and ...
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Pt describes getting a vaccine on 3/5, then on 3/8 woke up in the morning and was very confused and disoriented. This was experienced by her significant other. She went to bed again immediately and then woke up later at 3 PM.
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| 68 | 2021-03-16 | sleep disorder |
Stomach cramps, vomiting, chills 4 hours Sleep disturbance and fatigue for 6 days Headaches 4 days. ...
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Stomach cramps, vomiting, chills 4 hours Sleep disturbance and fatigue for 6 days Headaches 4 days. Handled by Ibuprofen or aspirin
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| 68 | 2021-03-17 | insomnia |
Chills for approximately 24 hours after Dizziness, overall weakness, and tiredness with inability to...
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Chills for approximately 24 hours after Dizziness, overall weakness, and tiredness with inability to sleep (ongoing, 6th day) Swelling of the face, particularly left side more affected (noticed on 6th day after injection) Bad taste in mouth and dryness Eye sockets darkened, more so in the left eye (noticed on the 4th day after injection; ongoing)
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| 68 | 2021-03-18 | feeling abnormal |
Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left a...
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Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 (Lot Number: EN6201) as single dose for covid-19 immunization. Medical history included sulfa allergy (reported as sulfa based) from an unknown date and unknown if ongoing. Concomitant medications reported as in two weeks included unspecified allergy nasal spray. The patient previously took codeine and experienced allergy. On 12Feb2021, at 13:00, the patient experienced initial injection slight pain; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy. There were no treatments provided for the events, and no noted COVID testing post vaccination. The outcome of events was not recovered.
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| 68 | 2021-03-18 | feeling abnormal |
She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vacci...
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She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vaccine, got up from that and had dry heaves, lost her speech and had loose stools. The aide caught her as she was fainting as she would have fallen on the floor. She said it was weird, she looked at people and it looked like they were 2 dimensional and knew something was wrong, but couldn't figure out what as they attended to her. They asked her questions, but she was not able to speak to them. They apparently spent 2 hours with her, but she doesn't believe it was that long, and then they knew she wanted to go to one Hospital and not the other. She had been loosing words before this happened, but not as bad as this one. This was about the same reaction that she had when she got the COVID virus in January. She was then taken to the hospital where she was given fluids and hydrated her and checked her heart, saw a cardiologist and a neurologist to see if those things caused the fainting and had blood work done. They also did a CAT Scan of her head and neck. They told her that she was fine and was discharged back home after 5 days, which was 3/11/21. Since then she has been very tired, she does have GERD and her stomach has been hurting a lot as well.
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| 68 | 2021-03-18 | insomnia, sleep disorder |
Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands...
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Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands suddenly started tingling, like pins and needles. That was on Feb. 11th, and now, March 19th I still have tingling everywhere from my neck down to my feet. Mostly arms and legs. It has gotten worse at times, then is milder, I notice it most when I try to fall asleep. The paresthesia keeps me awake or wakes me up. It also makes my heartbeat increase, along with hot flashes. I've been to the ER two times, have taken antihistimines but they do not agree with me. My doctor thinks it's a neuropathic reaction to the virus and will go away but it's been over 5 weeks and is still there. I will see a neurologist soon to rule out other possible causes, but I've never had paresthesia before, so think it must have been the Pfizer vaccine.
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| 68 | 2021-03-18 | nervousness |
Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point...
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Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point of almost fainting. I called 911 which I never would do normally but there was no one but me and I wasn?t sure what was happening. Medics took vitals and all was ok. By the time they arrived I was shaky but all other symptoms had gone.
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| 68 | 2021-03-18 | sleep disorder |
Very painful skin rash on back and chest. Still spreading as of 3-12-2021 and preventing sleep. Doct...
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Very painful skin rash on back and chest. Still spreading as of 3-12-2021 and preventing sleep. Doctor prescribed triamcinolone acetonide 0.1% for two weeks maximum. Still symptomatic after 1 week twice a day but seems to be calming down.
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| 68 | 2021-03-18 | sleep disorder |
I had significant pain at site of injection starting about 1 day after initial injection. From that...
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I had significant pain at site of injection starting about 1 day after initial injection. From that time unitl now I experienced shoulder and muscular pain intermittently around the injection site and throughout my left shoulder region. Sharp pains occurred with certain movements and at unexpected time. On 3/18/21 I experienced serious pain at the injection site and radiating down my left arm. I was unable to move my arm due to the pain. The pain was so severe (10 out of 10) that I couldn't sleep and I was concern it might be a heart attack. I went to an urgent care center, They did an EKG and assuerd me that it wasn't a heart attack. The physican diagnosed a frozen shoulder and asked about the timing of my Covid vaccine. I followed up the next day with my primary care physician and he suggested I report this as possibly related to vaccination. The pain today is still centered right at the injection site.
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| 68 | 2021-03-19 | feeling abnormal, anxiety |
Patient had a metallic taste in the back of her throat. She has a history of several allergies and s...
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Patient had a metallic taste in the back of her throat. She has a history of several allergies and she felt like she was going to have an allergic reaction. She became anxious and had slight shaking in her hands and legs. She removed her mask and jacket and sat calmly. We took her BP and Pulse Ox and she was normal. She sat for 1 hour and then felt better to leave. I followed-up with her 4 hrs later and she was okay but just didn't feel right. I advised her to come to the ER if her symptoms worsened.
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| 68 | 2021-03-19 | sleep disorder |
Severe chills for 1.5 hr despite multiple heated blankets, comforter, etc.; high fever, severe heada...
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Severe chills for 1.5 hr despite multiple heated blankets, comforter, etc.; high fever, severe headache (pain in ears and eyes as well as head), severe muscle and joint pain body-wide, skin painful to touch. Symptoms so severe that sleep was impossible for most of night. Headache severity lessened by 8a.m. 3/20, but is still present, and widespread joint pain, myalgia and fatigue continue up to the time of this report (24 hrs after injection).
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| 68 | 2021-03-20 | excessive sleepiness |
Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; ...
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Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
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| 68 | 2021-03-20 | sleep disorder |
First 48 hours fever 101 degrees, chest pain, aches, chills, unable to sleep due to pain everywhere ...
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First 48 hours fever 101 degrees, chest pain, aches, chills, unable to sleep due to pain everywhere Approximately 6 days later severe vertigo.....now still soon 4 weeks later, off and on vertigo mild to moderate. Blood work on 3/10/21 my basophils is high and my mean corpus all hemoglobin concentrate low. Two months before this shot, everything was normal
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| 68 | 2021-03-21 | amnesia |
Loss of memory of recent events of morning. Occurred when planting flowers. Lasted 3-4 hrs. Regaine...
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Loss of memory of recent events of morning. Occurred when planting flowers. Lasted 3-4 hrs. Regained memory little at a time by 6:00 pm same day. No headache, dizziness, or pain. No signs of physical distress. I knew who and where I was. Recognized the people I was with.
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| 68 | 2021-03-21 | excessive sleepiness |
severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expec...
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severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expected to confirm Sweet's Syndrome.
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| 68 | 2021-03-21 | mental impairment |
Blacked out completely while driving home on the highway about 50 minutes after the vaccine was admi...
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Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period.. After awakening, nauseated, vomiting, woozy, dizzy, felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made. Examined and tests done at Emergency room.
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| 68 | 2021-03-22 | feeling abnormal |
very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, bra...
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very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, brain fog, all my skin felt like it a bad sunburn its still not back to my normal state, cronic sinus issues for about 2 weeks with headaches,
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| 68 | 2021-03-23 | feeling abnormal |
Exacerbation of chronic fatigue, "burning" eyes, "brain fog", chills, metallic taste in mouth, mouth...
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Exacerbation of chronic fatigue, "burning" eyes, "brain fog", chills, metallic taste in mouth, mouth sores, decreased appetite.
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| 68 | 2021-03-23 | sensation of foreign body | "Feels like there's lump in throat". Evaluated by EMS-Cleared |
| 68 | 2021-03-24 | anxiety, nervousness, excessive sleepiness |
Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry...
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Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry and could not focus on anything- trouble standing up and not falling over- started at 6:30 Sunday morning and gone by 1 - except very fatigued, (slept mostly for 3 days) shaky (trembling) , no appetite , headache and chills- lasting thru to Thursday morning. Was very scary!
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| 68 | 2021-03-24 | anxiety |
Progress Notes (Nurse Practitioner) ? ? Hospitalist Expand AllCollapse All ...
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Progress Notes (Nurse Practitioner) ? ? Hospitalist Expand AllCollapse All Subjective Patient is a 68 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, . She denied rash. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, hypotension, increased swelling, rapid progression of symptoms and respiratory distress. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Musculo negative Previous Reactions: None Objective Vitals Vitals: 03/25/21 0852 BP: 132/71 BP Location: Left arm Patient Position: Sitting Pulse: 82 SpO2: 97% Physical Exam Eyes: Extraocular Movements: Extraocular movements intact. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: had patient remove mask and provide calming measures. Patient replaced mask before exiting clinic. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Patient responded to removing of facial mask and her lightheadedness resolved. Patient ambulated out of clinic with steady gait.
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| 68 | 2021-03-25 | feeling abnormal |
Felt exhausted, sciatic nerve in left buttocks flared up badly, felt a slight, brief chill like a fe...
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Felt exhausted, sciatic nerve in left buttocks flared up badly, felt a slight, brief chill like a fever for about 5 minutes, dizzy, felt out of it.
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| 68 | 2021-03-26 | feeling abnormal | Extreme Fatigue, brain fog, nausea, headache, body aches for 5 days |
| 68 | 2021-03-26 | nightmare, depression |
All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: inj...
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All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: injection site arm sore, fatigue, sleepiness, joint pain, diarrhea, bad nightmares for four (4) nights and bad dreams (unusual for me) for two plus nights after (I had nightmares after the first covid shot, too), minor dizziness for three days, chills, depression.
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| 68 | 2021-03-27 | excessive sleepiness |
2 days: sore arm, fever, aches, extensive sleep days 3-10 vaccination arm swollen lymph nodes with ...
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2 days: sore arm, fever, aches, extensive sleep days 3-10 vaccination arm swollen lymph nodes with low grade fever
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| 68 | 2021-03-28 | feeling abnormal, impaired work ability |
Got the vaccine, and the first 48 hours she had incredible body pain, every inch of her body hurt so...
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Got the vaccine, and the first 48 hours she had incredible body pain, every inch of her body hurt so bad. After 2 days that got better, although she still has some random pain. Really tired, really spaced out. Had a lot of pain when she breathed deeply for a few days, which has subsided now. She had headaches, tired, sleeping a lot, nauseous. She has been off work for about a week. She is a psychologist and having to cancel appointments. She still has fatigue and lays down a lot. She does have some brain fog. The inside of her ears have been itching a lot as well. She took some pain medications for the symptoms as well as nausea medicine. She called her doctor and he didn't give much advise other than rest and take the week off, drink a lot of fluids. She had extreme chills and put her thermostat on 74 to try to get over the chills, these lasted for several days and had some fever as well.
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| 68 | 2021-03-29 | feeling abnormal |
Patient went out of town and got very sick 2 days later.She was seen at a clinic there and given ant...
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Patient went out of town and got very sick 2 days later.She was seen at a clinic there and given antibiotics.She called the pharmacy to report the event .She said the arm was huge and red and very uncomfortable.We checked back on 3/27 and she was better just slightly red however still feels not herself.
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| 68 | 2021-03-29 | mental impairment | fevers, chills, arm pain, fatigue, unable to think straight, nausea |
| 68 | 2021-03-30 | depression, crying, insomnia |
Sudden onset severe depressive episode (no history of depression) starting 2 days after receiving th...
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Sudden onset severe depressive episode (no history of depression) starting 2 days after receiving the vaccine (3/12/21) which have been ongoing since then. Starting 3 days ago began having paranoid delusions (3/28/21-today). Frequently crying with no life stressors. Severe insomnia (a few hours of sleep in the past 5 days). Cataract surgery on 3/30/21, started experiencing feelings of hopelessness. Symptoms have been accompanied by poor appetite, intermittent dizziness over the past 2 weeks. PCP believes they may be related to vaccine.
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| 68 | 2021-03-30 | excessive sleepiness |
MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms...
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MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
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| 68 | 2021-03-30 | loss of personal independence in daily activities |
Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingli...
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Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingling; Struggle to do anything with arms or hands; Struggle to walk; Exacerbation of MS following first dose of vaccine; Legs are weak, numb, tingly; Legs are weak, numb, tingly; Legs are weak, numb, tingly; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 04Mar2021 08:00 as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history included multiple sclerosis from 1994 and ongoing Verbatim: MS. There were no concomitant medications. Historical vaccine included Tdap vaccine (DPT VACCINE) on 18Feb2016 for vaccination. The patient stated that she was looking for direction as well as reporting an exacerbation of MS following her first dose of the vaccine, clarified as the Pfizer Covid-19 vaccine, on 04Mar2021. Weight: Caller stated she would give her Covid weight. HCP: Caller reported that she is unsure of MD zip code. She reported that the phone number for her MD ends in DOCS but she did not know which numbers that corresponded to. Caller reported that she did not experience any of the common side effects from the first dose of the Covid-19 vaccine. She did not experience a sore arm, fever, muscle aches, none of that. She reported that she did not have any side effects until the afternoon of Saturday, 06Mar2021. Caller reported that she's had MS for many many years and that it has been in what she calls remission for a long time. She stated that the last exacerbation she experienced was following a Tdap vaccination five years before. Because of this experience, when the Covid vaccine came out, she went through her doctor to see what she should do, if she should get it. Her doctor recommended that she get the Covid-19 vaccine, but told the caller that she should make sure to go to a health care facility to receive it instead of drugstore or a clinic due to her experience following the Tdap vaccine in 2016. Caller reports that she is now having a similar exacerbation following the Covid-19 vaccine. Exacerbation of MS: Caller stated that it is an ongoing exacerbation that is not getting better. She stated that she's sure that it will get better, but she is not sure what she should do about the second dose. Legs weak, numb, tingly: Caller reported that the weakness, numbness, and tingling in her legs was progressive. She stated that the weakness, numbness, and tingling began on Saturday afternoon, 06Mar2021, in her feet and lower legs, and had then progressed to her thighs by Sunday 07Mar2021 or Monday 08Mar2021. Arms are weak, numb, tingly: Caller reported that she noticed on Sunday, 07Mar2021 that her hands were a little clumsy. She reported that throughout the day of Sunday, 07Mar2021 and Monday, 08Mar2021, the numbness and tingling progressed into her upper arm. Facial tingling: Caller originally stated that she has been experiencing a lot of nerve sensation, then clarified as facial tingling, in particular around the mouth, below the nose, and on both sides of her face. She stated that it began on Sunday, 07Mar2021 and was intermittently present on 08Mar2021 probably into 09Mar2021, then it just went away. She stated that it would come and go. Caller reported that while she is able to walk and has not had to use her wheelchair, that it is a struggle to walk. She also reported that it is a struggle to do things with her arms and hands. She stated that if she wanted to eat, in order to pick up the fork she would probably be using 2 hands to get the fork up but can use it once it's in her hands. She also reported that a pencil is difficult to pick up as well, stating that she would need to use both hands to pick it up but would be able to use the pencil once she had picked it up. Caller reported that the tingling comes and goes, and she experiences varying degrees of numbness. She reported that they are a little numb throughout the day and it may get worse depending on what she's doing. She stated that she isn't a sitter, she has to get up and move. Caller reported that she called her physician, about the side effects she was experiencing and they instructed her to go to the Emergency Room. She stated that their concern was what was going on and if it could be Guillain Barre disease, which she stated is extremely rare. Caller reported that when she went to the Emergency Room on 09Mar2021, they did not really do any tests. She stated that in order to see if there were any new lesions for the MS, they would have to do an MRI of her brain. Caller reported that they did not believe that there were any new lesions, that they thought it was old lesions. Caller reported that they told her to go home and make an appointment with the neurology resident clinic for that week, clarified as last week, week of 09Mar2021. Caller reported that she called the neurology clinic as she does not currently have a neurologist, and they informed her that they would not be able to get her in for an appointment until the end of Apr2021. She stated this was not doing her much good. Caller stated that they had wanted to admit her to the hospital, but told her that she could go home if she promised to follow up with the neurology resident clinic. Caller expressed some frustration, stating that she was really trying to reach out to see what she should do regarding the second dose. Her physician tells her to go to the Emergency Room, the Emergency Room tells her to go to neurology. She wants to know what will the second dose do. She stated that she called the (state) chapter of the national MS society this morning, where they informed her that they had not heard any reports of exacerbations from the Covid-19 vaccine. Caller states that getting additional doses of the Covid-19 vaccine is a lifelong decision. She stated that Covid may not always be a pandemic, but it could come back like a yearly flu. She stated that because additional doses of the Covid-19 vaccine could be required, she wanted guidance on how to proceed. Her second dose of the Covid-19 vaccine is scheduled for 25Mar2021. Clinical outcome of facial tingling was recovered on 09Mar2021, while for the rest of the events was not recovered. Information about Batch/Lot number has been requested.
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| 68 | 2021-04-01 | feeling abnormal |
I became dizzy and light and foggy headed after both shots a week later. 3 weeks ago I was mowing th...
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I became dizzy and light and foggy headed after both shots a week later. 3 weeks ago I was mowing the lawn and became light headed and fell backwards on the grass but did not hurt myself
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| 68 | 2021-04-01 | sleep disorder, disturbance in attention |
I am an avid meditator and I have developed tinnitus soon after my second shot I can not meditate ,...
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I am an avid meditator and I have developed tinnitus soon after my second shot I can not meditate , it is so laud and distracting . Hard to sleep due to the noise.
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| 68 | 2021-04-01 | sleep disorder |
sore arm (including right arm from first injection), temperature 100.8, hard shaking chills for eigh...
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sore arm (including right arm from first injection), temperature 100.8, hard shaking chills for eight hours (then low grade for 48 hours, very severe muscle pain, very severe joint pain accompanied by severe muscle cramps torso to feet for 48 hours, severe headache for at least 72 hours, drenching night sweats for two nights, nausea, bowel cramping and frequent stools, fatigue but inability to sleep, loss of appetite (but increased sense of smell).
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| 68 | 2021-04-03 | feeling abnormal |
@2-2:30 AM got shakes-not shivers but a bit cold. Went to bed. Awoke feeling hot. Hubby took temp....
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@2-2:30 AM got shakes-not shivers but a bit cold. Went to bed. Awoke feeling hot. Hubby took temp. 95? Felt nauseous. Wanted only water. Slept all day Wed. 3-17. When awake felt nauseous to the point of feeling likely to throw up. Sat on floor by commode till feeling passed. Had to have help getting up as legs didn't want to move. Brain was in a fog. Couldn't think. Went back to bed. No appetite. Had a dry cough enough to make stomach muscles hurt. Slept through the night. Thurs.3-18 still felt nauseous. No energy. Ate some crackers. Fri 3-19 Felt like getting dressed and take a car ride. Still no energy. Still nauseous but less so. Sat.3-20 Started to feel like old self. No nausea. Wanted to eat. Clear headed but a slight headache. Some energy returned.
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| 68 | 2021-04-04 | sleep disorder |
Day 1: mild fatigue Day 2: severe dizziness resulting in multiple episodes of emesis, multiple near-...
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Day 1: mild fatigue Day 2: severe dizziness resulting in multiple episodes of emesis, multiple near-miss fall incidents throughout entire day - reported that she was woken up by feeling dizzy Day 3: ongoing dizziness w/ N/V, mild vertigo - mild improvement w/ 25 mg dose of meclizine Day 4: ongoing dizziness, mild vertigo when turning head/eyes, looking up/down - continues to take 25 mg meclizine BID-TID w/ mild improvement Day 5-current: ongoing dizziness w/ mild vertigo when turning head/eyes, looking up/down
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| 68 | 2021-04-06 | feeling abnormal |
reports vague symptoms of feeling " lightheaded, foggy- changing to a heavy feeling in her occipital...
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reports vague symptoms of feeling " lightheaded, foggy- changing to a heavy feeling in her occipital region." no other associated S&S. A&O x 3, conversant; following commands. Symptoms improved but not resolved after 15 mins. TX: mask removal; fresh air; seat reclined X 10 mins; Sat upright & given bottle of water; will allow to relax & recheck after 15 mins.
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| 68 | 2021-04-06 | nightmare, feeling abnormal |
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo...
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Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
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| 68 | 2021-04-08 | sleep disorder |
After 2nd dose I sat there for an hour because I have a lot of allergies, 3-4 days later there was a...
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After 2nd dose I sat there for an hour because I have a lot of allergies, 3-4 days later there was a humming in my ears and I thought that it was apart of my allergies, then it started bothering me and I couldn't sleep, I tried sleeping with a white noise sounds but the humming in my ears was still there. I saw the doctor on 3/18 and was given medicine for congestion and blocked ears, it didn't work and Doctor gave me a low dose steroid.
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| 68 | 2021-04-08 | thinking abnormal, excessive sleepiness |
Exttremely tired, slept 4/01-4/03 most those days, and slowly increased energy following days, but s...
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Exttremely tired, slept 4/01-4/03 most those days, and slowly increased energy following days, but still required more rest than normal; pounding headache; sores on legs that itched, kind of like bumps that seeped if scratched too hard. Couldn't watch TV. Eyes had trouble focusing. Eight days after vaccine I got a few new itchy bumps, and stll low on energy, and have a headache that isn't as bad. Still having trouble thinking, brain isn't working as sharply.
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| 68 | 2021-04-09 | anxiety, feeling abnormal, crying |
Headache which got worse 2 hrs after vaccine and then worse at 10 hrs after vaccine. Dizziness for 2...
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Headache which got worse 2 hrs after vaccine and then worse at 10 hrs after vaccine. Dizziness for 2 days after vaccine, slight fever overnight 8 hours after vaccine and into the end day. MAJOR DEPRESSIVE AND ANXIETY SYMPTOMS. CRYING ALL DAY FOR 2 days. Stomach anxiety. Feeling of dread and doom and fear of going to hell for 2 days and is still not resolved as of 04/10/2021
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| 68 | 2021-04-09 | excessive sleepiness |
Cold; Chest pain/Chest soreness under left breast to back and side, hurt like heck when she moved; C...
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Cold; Chest pain/Chest soreness under left breast to back and side, hurt like heck when she moved; Chills and feeling cold; Chills and feeling cold; Horrible nausea to the point where she feels weak and has no strength, the nausea took her appetite too; headache; Feeling unwell/sick; Horrible nausea to the point where she feels weak and has no strength, the nausea took her appetite too; Horrible nausea to the point where she feels weak and has no strength, the nausea took her appetite too; She needs something for her stomach, it is upset; couldn't even wake up sleeping more than usual- Hard for her to wake up because she was feeling sick; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Pharmacy, via an unspecified route of administration, in left arm on 20Mar2021 around 11:30-12:00, at 68 years of age, (Batch/Lot number EP6955) as single dose (0.3 dosage units unknown, injection) for COVID-19 immunization. Medical history included allergies - she had them all her life and she let her doctor know before receiving the vaccine: she was highly allergic to second hand smoke and severely allergic to cats since an unknown date, hypersensitivity from 2020 and ongoing, diabetes mellitus from 2005 and ongoing, hypertension from 2005 and ongoing and she had a family medical history of high blood pressure. Concomitant medications included metformin for blood glucose increased from 2005 and ongoing; glimepiride for diabetes mellitus from 2005 and ongoing; atenolol taken for hypertension from 2005, amlodipine for hypertension from 2020 (they switched her from another unknown medication - they no longer use that one anymore), all taken by oral route, and vitamins. On 21Mar2021 in the morning the patient woke up with the headache and nausea, she experienced chills (with no fever) and feeling cold, horrible nausea to the point where she feels weak and had no strength, the nausea took her appetite too, she had headache, was feeling unwell/sick, she needed something for her stomach as it was upset and she couldn't even wake up, she was sleeping more than usual, it was hard for her to wake up because she was feeling sick (caller explained when she gets sick and doesn't have the strength she needs, she does a lot of sleeping) and suffered from chest soreness under left breast to back and side, it "hurt like heck" when she moved. On the same day at around 16:00 the patient experienced chest pain that hit her so bad that she thought she was having a heart attack. Moreover, on an unspecified date, she experienced cold. The patient clarified she did not have a rash, redness, or itching - none of that. The patient didn't go to the Emergency Room or physician office. The patient reported that she called the doctor and he told her to wait it out for a week and if it gets worse or doesn't subside by the end of the week, then go to Emergency Room. The patient stated that she does not like to take pain pills, but that headache got her. She did not take anything, but she drank some ginger tea to help her stomach. The events "chest pain" and "chest soreness under left breast to back and side, hurt like heck when she moved" resolved on 22Mar2021 but the patient explained that when her chest pain subsided, it hurt her to move. The caller clarified she hasn't had that episode since Sunday [21Mar2021] and explained the only thing that lasted was the soreness and hurting to move, but the next day she didn't have that problem; no chest pain or soreness the next day (the next day, it was still a little sore, but as the day progressed she didn't feel it anymore, the soreness was very mild on 22Mar2021); the events "chills and feeling cold", "horrible nausea to the point where she feels weak and has no strength, the nausea took her appetite too", "headache" and "feeling unwell/sick" had not resolved yet at the time of the report (she feels like nausea was leveling out; it's not getting worse and it's basically balanced; she is hoping the nausea will subside as she doesn't like this), the event "she couldn't even wake up, she was sleeping more than usual, it was hard for her to wake up" was recovering and outcome of the events "needed something for her stomach as it was upset" and "cold" was unknown. Follow-up activities were performed for additional information.
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| 68 | 2021-04-12 | confusional state, mental status changes |
68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE. DAUGHTER STATE...
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68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE. DAUGHTER STATES INCONITNENCE STARTED Friday 4/9 AND FEVER AND CONFUSION STARTED TODAY WITH SHORTNESS OF BREATH. PT WAS SEEN AND SWABBED FOR COVID AND FLU BUT REFERRED TO ER FOR FURTHER EVAL AND WORKUP. PT IS DIABETIC BUT DAUGHTER REPORTS NOT KNOWING WHERE ACCUCHECKS ARE AS THEY HAVE NO MONITOR AT HOME. Admitted Inpatient 4/13/21
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| 68 | 2021-04-12 | mental status changes, confusional state |
Patient presented with weakness and AMS. On admission, patient had severe hyponatremia and confusion...
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Patient presented with weakness and AMS. On admission, patient had severe hyponatremia and confusion continued as was also found to have supratherapeutic tacrolimus level. Patient started experiencing respiratory symptoms on day 2 of admission requiring O2 and treatment for COVID.
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| 68 | 2021-04-13 | feeling abnormal |
4-3 3:00PM R wrist swelled, rash red like sunburn 4-4 Tired; lack of appetite 4-5 Rash on chest, ba...
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4-3 3:00PM R wrist swelled, rash red like sunburn 4-4 Tired; lack of appetite 4-5 Rash on chest, back, face 4-6 Dr. prescribed Benadryl every six hours. 4-8 Dr. prescribed Prednisone 4mg as rash was still there and I had swelling and rash on palms. Stopped Benadryl as I was jittery and in a fog 4-9 Swelling R hand and fingers, starting to itch all over body then get hives 4-11 Rash went away on chest, back, and face 4-12 Reported to Dr. that rash was still on palms and he sent me to Urgent Care. Took Zyrtec at night. Urgent Care checked hands hands for numbness which I didn't have and said I must contact the CDC. 4-13 Finished Prednisone in the morning. Took Zyrtec at night. Stopped itching but rash continues on palms of hands- looks like sunburn. 4-14 Joint swelling when I woke up. Tingling in L fingers and hand, called Dr. He said that I'm retaining fluids from Prednisone and it's affecting my nerves. Urgent Care, the pharmacy and Dr. do not know how to help me. They can't tell me when my symptoms should go away or what I should be taking. You can also call me on my cell?
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| 68 | 2021-04-13 | sleep disorder, crying |
She got her vaccine, and by evening her arm was swollen, puffed up and she can barely move her arm. ...
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She got her vaccine, and by evening her arm was swollen, puffed up and she can barely move her arm. It is very painful and she is not able to use it. Her husband said that she was moaning and crying out in the night. She took 2 hydrocodone/Acetominophen 5/326 which did not alleviate her pain, which she has taken twice, but not relief of the pain.
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| 68 | 2021-04-14 | sensation of foreign body |
Client reports feeling a lump in her throat after vaccination. Fire Rescue at scene to evaluate clie...
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Client reports feeling a lump in her throat after vaccination. Fire Rescue at scene to evaluate client. Client reports symptom subsided. Vitals all wnl. Per Fire Rescue, no further eval. needed. Client released at 10:32am.
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| 68 | 2021-04-15 | loss of personal independence in daily activities, impaired work ability, excessive sleepiness |
I have experience moderate fatigue (needing to sleep 15 hours each day to feel rested when I used to...
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I have experience moderate fatigue (needing to sleep 15 hours each day to feel rested when I used to sleep 8-9) and diarrhea (moderately interrupting daily schedule) for four (4) weeks now. I have had to take time off from work to get extra sleep every week and sleep away most weekends. The diarrhea would not be manageable if I were at my workplace and not working from home, with 2-3 daily loose stools. I also feel chills. Oddly, I have lost no weight, just my bad luck. I figure if I start to lose weight, I will see my doctor.
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| 68 | 2021-04-17 | amnesia |
testing positive for covid; 24 hour amnesia; This is a spontaneous report from a Pfizer-sponsored pr...
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testing positive for covid; 24 hour amnesia; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 68-year-old female patient (reporter's mother) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient had an accidental finding of COVID positive on 19Mar2021. She had blood work when she had an overnight stay at the hospital but everything was fine. The patient was completely asymptomatic other than that. It was also reported that the patient ended up having 24 hour amnesia (as reported) on an unspecified date in Mar2021. During the day of the report, 01Apr2021, the patient was due for her second shot but was not allowed to get her second shot that day and that she needed to wait at least a month. The reporter wanted to know if this was correct. The patient did not receive treatment for the events. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the timing of finding a Covid positive test relative to day of vaccination, event 'Covid-19' was an intercurrent medical condition assessed not related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-04-17 | feeling abnormal |
her MS symptoms exploded; head became foggy; blurred eyes; slight headache; This is a spontaneous re...
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her MS symptoms exploded; head became foggy; blurred eyes; slight headache; This is a spontaneous report by contactable consumer(patient) from Pfizer Sponsored program. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Mar2021 at single dose for COVID-19 immunization. Medical history included Multiple Sclerosis (MS) for 20 years and autoimmune disease. Concomitant medications included interferon beta-1a (AVONEX) for MS. The patient previously took Avelox for MS. Caller also states she would like to report that she has a history of Multiple Sclerosis (MS) and she goes to the clinic. Caller states since no studies were done on people with MS, she would like to report her experience. Caller states she received her first dose of the vaccine on 17Mar2021 and hours afterwards her MS symptoms exploded. Caller states she has had MS for 20 years and she doesn't even realize she has it because she is able to walk the dogs at the pound and she does 3600 steps a day and it doesn't keep her from doing anything. Caller states after the shot she has torn meniscus in her knees and her knees were so tight and she has heel spurs, and they were burning and hurt. Caller states she hurt her hand previously and her hand was tight, and it felt like it was going to explode. Caller states every injury she has ever had it felt like it was exacerbated and got worse. Caller states she was instructed by the Clinic to take Tylenol every 6 hours and these symptoms lasted for 12 days. Caller states she takes a medication called Avelox for MS once a week and she didn't take it after the shot because it is known to cause flu like symptoms, but she is back taking it now. Caller states she was working on the computer and her head became foggy and this lasted for six or seven days. The caller has MS and is on Avonex, it's a beta 1 interferon injectable that she has been taking for over 20 years. The caller's doctors told her it was okay to get the shot. Because of the caller's autoimmune disease, the caller's doctors don't know how effective the shot will be with an autoimmune disease. The caller has done well with Multiple Sclerosis; her Multiple Sclerosis was really good she was walking 3600 steps a day. The vaccine seems to have flared up everywhere the caller has been hurt. It made those spots worse. The caller had a torn meniscus and it felt like her knee was stiff like a board. The caller had a bone spur in her foot that it began to hurt where that was removed. The caller broke her left hand and then it felt like it was going to explode. The caller also had head fog and blurred eyes. It took 6-7 days for head fog to get better. The other symptoms it was 12-13 days to get better. The caller also had a slight headache. The clinic said there were no studies in someone with MS who took the covid vaccine, they only reported to them about the autoimmune disease. Someone on the thing said the second dose was 10 times worse than the first one. Then the caller was told if she gets those symptoms with the first shot then the second one will be better because your body is used to it and knows what to do. It is kind of like a trial by fire and no one knows what to expect. The caller wants to know if Pfizer had any information on Avonex interfering with MS. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-04-17 | excessive sleepiness |
flu like symptoms; Fever/low grade fever at night; body aches; excessive sleeping; vaccine arm enlar...
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flu like symptoms; Fever/low grade fever at night; body aches; excessive sleeping; vaccine arm enlarged lymph nodes; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration in left arm on 18Feb2021 11:30 (68-years-old at the time of vaccination), as single dose for covid-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9263), via an unspecified route of administration in left arm on 28Jan2021 11:30, as single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered:Public Health Clinic Administration facility. Medical history included chronic lymphocytic leukaemia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Feb2021 at 11:30, the patient experienced flu like symptoms, fever/low grade fever at night, body aches, excessive sleeping and vaccine arm enlarged lymph nodes. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
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| 68 | 2021-04-19 | abnormal dreams, insomnia |
A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day...
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A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day. Five days after the vaccination I started to go into a sweat if I exerted myself too much. I continued to have a dizzy head and my stamina was greatly reduced. I used to ride my exercise bike for 90 -150 minutes a day but after the vaccine I could only go 20 minutes the first week and then I got progressively weaker and more dizzy. I could barely walk a half block. I also experienced some shortness of breath and a racing heart at times. The third week out was the worse. I could hardly care for myself. I started to get a lot of pain behind my eyes and other sinus pressure. Also the lymph gland under my ear was swollen and painful. I was extremely tired for a couple of days at that point but have found it hard to sleep on most other nights. I have strange dreams that are almost like an hallucination. I also have head aches but they seem to have improved as the weeks have gone by, especially since I have been taking Aleve every day. I am unable to exercise and have very little energy still. The dizzy head continues to persist even 6 weeks out. I had this same kind of dizzy head in August when I had Covid but it went away in a week or two. I get dizzy just reading a book or looking at my piano music also. Having had Covid twice I am very confident that these symptoms were caused by this vaccination. It also seemed to make my blood sugar more volatile. The sad thing is that I was feeling perfectly normal when I went in! I am devastated by these symptoms and they have completely altered my life. I am so discouraged that they never go away. Some days I feel like I am improving and then they pop up again. I was a very active person and now I can hardly do anything. I think I got the shot too close to when I had covid and that it has triggered an immune response that is overwhelming my body. Will it ever get better? I can't stand to go on like this!
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| 68 | 2021-04-19 | confusional state, feeling abnormal |
MRN: 7049276; DOB: 5/9/1952; dose #1: 3/23/21 Lot # EN6208 ? LD site; dose #2: 4/13/21 Lot # ER8732 ...
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MRN: 7049276; DOB: 5/9/1952; dose #1: 3/23/21 Lot # EN6208 ? LD site; dose #2: 4/13/21 Lot # ER8732 ? LD site; Patient had a history of chronic back pain. She recently underwent spine stimulator placement. She presented to the emergency room with some nonspecific complaints to include fatigue, myalgias, and some increasing confusions from baseline per her family. She got a second dose of the COVID-19 vaccine on 4/13 and following day, she had been feeling poorly.
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| 68 | 2021-04-19 | feeling abnormal |
Felt dizzy and couldn't feel feet while walking (felt like walking on air). Had to go to bed. When ...
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Felt dizzy and couldn't feel feet while walking (felt like walking on air). Had to go to bed. When I woke up I was wet from sweating. This lasted for 3 days. Arm was swollen, itching, and painful for one week. Arm was red and warm at vaccination site. Felt tired for 8 days.
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| 68 | 2021-04-19 | sleep disorder |
Extreme fatigue, restless sleep, headache, digestive problems, eye and visual problems, skin irrita...
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Extreme fatigue, restless sleep, headache, digestive problems, eye and visual problems, skin irritation, sore throat
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| 68 | 2021-04-21 | feeling abnormal |
Nausea, chills, low grade fever, headache, body aches, fatigue - started at 5:00pm five days after v...
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Nausea, chills, low grade fever, headache, body aches, fatigue - started at 5:00pm five days after vaccination - fever resolved with Tylenol - remaining symptoms resolved with rest. Still feeling fatigued and fuzzy-headed on day following onset of symptoms.
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| 68 | 2021-04-22 | sleep disorder |
She got the vaccine at 2:00, around 4:00 she started with fatigue with headache, dizziness, somewhat...
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She got the vaccine at 2:00, around 4:00 she started with fatigue with headache, dizziness, somewhat blurry vision (not extreme), chills up her full spine to her head from the bottom. She also at that time noticed a lump on her right arm and difficulty raising her arm straight out due to severe intensity of pain. She had difficulty of neurological function and paralysis and reaction of the right leg to just above the knee into her toes. She had paralysis feeling and also heavy swelling that was noticed by 6:00 that day. She also noticed that night that no position gave her comfort to be able to sleep, which kept going and she still has the paralysis, numbness, chills, fatigue. The headaches are getting sharper, more intense in her right temple area which is very sharp, which is not normal for her. The tumor she had gave her squeezing headache pain across her eyes and the to of her head but not the temples. The 2nd shot brought about 3 days of wheezing, which she does not have any lung or heart issues. She has been having difficulty with just having normal breathing patter as she does not feel it is quite right for getting oxygen as it had been prior. She went to her PCP last Friday, 4/16/21 who has ordered an MRI. He has consulted with the neuro-specialist that she had with her tumor. He will follow through with more blood work more than likely. He did mention to her about having a COVID test to double check that end of that. She did not have this done due to the fact that she had the brain tumor surgery and that is how they did that approach. She was just staring to have resolution of some of her symptoms from the 1st vaccine from the right leg when she got this one. When she got the 2nd vaccine she had intense swelling in the left leg from the knee down. There is a definite difference in the size of the legs. Her PCP said that there is definite damage from his testing at her recent appointment.
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| 68 | 2021-04-23 | anxiety |
Low grade headache; arm site pain; un-wellness/feeling unwell; muscle ache; fatigue/ tiredness; anxi...
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Low grade headache; arm site pain; un-wellness/feeling unwell; muscle ache; fatigue/ tiredness; anxiety; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (COVID-19 vaccine, Lot Number: EL9264), via an unspecified route of administration in the arm on 28Jan2021 (at the age of 68-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. On unspecified date in 2021, the patient experienced low grade headache, arm site pain, un-wellness, muscle ache, fatigue/ tiredness and it has lasted beyond 72 hours, and anxiety, but it's hard to tell if because the patient have been feeling unwell that's causing anxiety or if that was a side effect somehow. On unspecified date in 2021 (72 hours ago), the blood test was taken with unknown result. The patient will have the second dose on Thursday, 18Feb2021. No treatment was received for the events. The outcome of the event anxiety was unknown while the other events recovered on unspecified date in 2021.
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| 68 | 2021-04-24 | insomnia |
Racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody ...
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Racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; General weakess; insomnia; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 68-years-old female patient (Non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:45, as SINGLE DOSE for COVID-19 immunisation. Medical history included colostomy, osteoporosis and seizure (Grand Mal Seizures). The patient had no known allergies. Concomitant medications included felbamate (FELBATOL); levothyroxine sodium (SYNTHROID), lisinopril (ZESTRIL); calcium carbonate (OSCAL [CALCIUM CARBONATE]) and vitamin c [ASCORBIC ACID]). On 21Jan2021, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in Arm Left, as SINGLE DOSE for COVID-19 immunisation. Patient not received COVID prior vaccination. Patient not tested for COVID post vaccination. On 21Feb2021 (13:00), the patient experienced racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; general weakness; insomnia. Patient not received treatment for the events. At the time of this report event outcome was recovering. No Follow-up attempts are needed. No further information is expected.
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| 68 | 2021-04-26 | loss of personal independence in daily activities |
Pt developed chest pain early am day following vaccine administration, presented to ED on 4/25 and w...
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Pt developed chest pain early am day following vaccine administration, presented to ED on 4/25 and was diagnosed with pulmonary emboli. She had recent muscle strain and chest/back pain that she attributed to lifting heavy objects the week prior to the vaccine (4/15), and had been mostly staying in bed or on the couch with minimal movement/activity 4/15-4/22 due to those symptoms.
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| 68 | 2021-04-27 | feeling abnormal, insomnia, confusional state |
aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap...
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aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion. The patient's concomitant medications were not reported. The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today on an unspecified date with outcome of unknown , painful and hard on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful on an unspecified date with outcome of unknown , definitely something abnormal on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen on an unspecified date with outcome of unknown , congested in her chest on an unspecified date with outcome of unknown , she is feeling a little confused on an unspecified date with outcome of unknown , chills on 12Apr2021 with outcome of recovered , fever on an unspecified date with outcome of unknown , felt achy on 12Apr2021 with outcome of not recovered , excruciating pain in my head on 13Apr2021 with outcome of not recovered , swelling of my arms and hands on 12Apr2021 with outcome of recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-29 | confusional state |
Milf confusion, escalating to severe cold symptoms. Severe fatigue and sleepiness. Fever of 101, tak...
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Milf confusion, escalating to severe cold symptoms. Severe fatigue and sleepiness. Fever of 101, taken under arm
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| 68 | 2021-04-29 | feeling abnormal | Brain fog, Full body aches, Pain still on right side of body, reduced hearing in right ear |
| 68 | 2021-04-30 | confusional state |
confused/When talking to her she is talking out of her head/hought her condo was turned completely a...
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confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-30 | feeling abnormal |
today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is ir...
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today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is irritating her lungs and she can't stop; it was making her lungs hypersensitive.; all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2; burning in her stomach and a stomach ache; burning in her stomach and a stomach ache; never has that much energy when she was normal/had tons of energy; woke up on day 4 in the middle of the night and her lungs were pinching, pinching, pinching, like and asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it; tired; had weakness with climbing stairs and with exertion/ zapping her energy; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Apr2021 14:40 (lot number: EW0150) at age of 68 years as single dose for COVID-19 immunisation. Medical history included low vitamin D, lungs were working at 75% the capacity of an 84 year old and not 68 year old and asthma attacks. Concomitant medications included vitamin D2 and D3 and regular vitamins for low vitamin D, had been taking that for 6-7 weeks, tiotropium bromide (SPIRIVA RESPIMAT) 2.5mcg takes 2 inhales a day in the morning and salbutamol sulfate (PROAIR) 2 puffs and a special medication because her lungs were working at 75% the capacity of an 84 year old and not 68 year old and put her on an asthma medication to open her lungs. Patient got a flu shot every year and got it in Jan2021 and nothing. Patient stated that her symptoms were mild. Patient stated on day 1 after she got the shot she had nothing, that was 07Apr2021. Stated the next day (08Apr2021) she did not have injection site soreness but 2 inches below the injection site the muscle was hard and swollen and sore and remained that way for days 2, 3 and about day 4 it started to recede and day 7 it was tender. Stated it was one muscle and it was below the injection site, not at the injection site. Stated it was a lifting muscle, if she lifted her arm up it could only go so far and she would feel it and drop her arm down. Stated she got the injection in her left arm as she used it the least. Stated on days 2 (09Apr2021), 3 and 4 she had weakness with climbing stairs and with exertion, she could do it but she would notice it was more of a struggle. Stated that today she was off kilter again. Patient relayed that she looked all over online to see if she was sick with something. Stated she was tired on days 3 (10Apr2021) and 4 and that on days 5 (12Apr2021) and 6 she had tons of energy and she worked from dawn to dusk waxing floors and never has that much energy when she was normal. Stated that all of a sudden on day 5 and 6 she was perfect and then toward the evening of day 6 she thought it was her as she had to go to the Secretary of States and stand in line to renew her license and she did well and got home and started feeling tired. States she woke up last night of day 6 (13Apr2021) with a burning in her stomach and a stomach ache and it woke her and made her feel like she had food poisoning or something like that and nothing happened and she took 2 Tums and it kind of settled that down. Stated on day 7 (14Apr2021) she woke up and the stomach part was gone and all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2, which is not much for most people but she feels and she took Motrin and after that she still feels a heaviness in her eyes and her temperature is 98.6 and she is normally in the 97's and was running a 2 degree fever and now maybe a 1 degree fever and she felt it in her eyes and didn't feel sick. Stated she felt fatigued like she want to take a nap but didn't feel ill. Stated whatever was going on was zapping her energy. Stated she woke up on day 4 (11Apr2021) in the middle of the night and her lungs were pinching, pinching, pinching, like an asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it. Stated this hadn't happened and she had been taking the special medication for 3 weeks now and it was very rare for her to get those attacks and this was worse than any. Patient relayed that today all day even with the special medication to open her lungs she can feel in her lungs that they were, she can't explain it, like they are gripping and releasing and gripping and releasing a little but. Stated she knew she was having some kind of asthma thing going on, it was not making her cough it was making her lungs hypersensitive. Stated she was expecting everything and she did read and nobody had symptoms that last more than 7 days and she was expecting them to be gone tomorrow, or she hopeed anyways. Stated the last 10 days had been easy-peasy and all of a sudden she was waking with all that coughing like something was irritating her lungs and she can't stop. Patient provided that it woke her husband up with her coughing for half an hour. States this lasted half an hour and was more than normal and something really irritated her lungs, shouldn't have happened as she is on the other thing every day and has not had an attack with that. Patient stated her provider didn't know as it was so relatively minor and was unusual but minor and she did not feel like it was life threatening. Stated her brother had Covid and she did not feel like she was trying to breathe and couldn't, or suffocating and dying. She did not feel that. The air irritated to even breathe and made her cough and couldn't stop and that was the first time she had to use an inhaler on top of on inhaler and something made her lungs respond to nothing there. Stated it may be her immune system thinking something was there, the headless thing in her lungs. Patient stated she thought she was over it and then got the fever not understanding if the fever was Covid related and she stayed at home and didn't go out until yesterday it was the 1st day out since Thursday and how could she have caught anything if she wasn't near anybody. Stated these were just thoughts in her head. Outcome of events was unknown.; Sender's Comments: The reported event of asthma aggravated was assessed as possibly related based on temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 68 | 2021-04-30 | insomnia |
Severe stiff neck; Can hardly sleep; so sick the day after and slept all day; Neck was sore/neck is ...
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Severe stiff neck; Can hardly sleep; so sick the day after and slept all day; Neck was sore/neck is still sore, but not severe; Nauseous; so sick the day after and slept all day; can hardly move it; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration at the age of 68-year-old on 07Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 for COVID-19 immunization and after the first dose, she only had a mild headache. She experienced a severe stiff neck after the second dose in Apr2021. It has been 5 days. She can hardly move it and can hardly sleep in Apr2021. She was so sick the day after and slept all day in Apr2021. The next day was better. Then her neck was sore and she got nauseous in Apr2021. Her neck was still sore, but not severe. She wants to know if she should wait a whole week and then see her doctor or does she need to see a doctor now. She received the second dose last Wednesday (07Apr2021) and still has symptoms today. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-05-03 | feeling abnormal |
fever; fatigued; Did not have much energy/having no energy/low energy; Left Arm was painful and it g...
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fever; fatigued; Did not have much energy/having no energy/low energy; Left Arm was painful and it got swollen a bit; Left arm painful; Foggy and not clear; extreme shortness of breath/cannot catch her breath; almost hyperventilating/Hyperventilation; This is a spontaneous report from two contactable consumers (including husband and patient self) and patient self. A 68-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6204) at single dose on 20Mar2021 14:54 injected in left arm in the muscle for Covid-19 immunization. Medical history included shortness of breath, hypothyroidism and COVID-19 back in Dec2020. She had some food allergies that were diagnosed prior to getting the vaccine. Patient was tested positive for COVID on 21Dec2020 and negative on 20Jan2021. The symptoms followed for patient was a little coughing and no smell for 3 days and a little shortness of breath. Family medical history was none. Concomitant drug included levothyroxine 0.75 ug, once daily for hypothyroidism, which was taking for 15 years (as of 19Apr2021). No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. Patient experienced left arm painful on 20Mar2021 about an hour or two after she got the injection, did not have much energy on 21Mar2021 08:00, foggy and not clear from 21Mar2021 to 22Mar2021 08:00, shortness of breath started 24Mar2021 or 25Mar2021, and hyperventilation on an unknown date in Mar2021 (reported as a week or 9 days after receiving vaccine). The shortness of breath was what she referred to as hyperventilating. That came a week after the vaccine. The same date they took shot was when the arm pain started and the low energy was the day after. Foggy and not being clear was from 21Mar2021 to 22Mar2021. Shortness of breath started 24Mar2021 or 25Mar2021. In additional to shortness of breath, she had been hyperventilating. That began approximately a week or 9 days after receiving vaccine. Left arm was painful and it got swollen a bit and lasted for 48 hours. The husband experienced arm pain and said he almost had a fever and felt fatigued. The reporter thinks patient (his wife) felt the same. She had arm pain and not much energy. They came out of that ok. About a week after the first injection, she just cannot catch her breath. She started hyperventilating to the point where the husband thought she would expire. She also experienced being foggy and not clear and having no energy. First, she went to a Cardiologist and he said there was nothing wrong. She then saw a lung doctor who send for respiratory chest and did chest CT scans and everything was clear on both test. He did not prescribe any medications. A week after she saw him, she went to the ER on 31Mar2021for hyperventilation and shortness of breath. They prescribed Xanax (AER 2021434900). She said it did not work and they prescribed something else. It was 25 mg twice a day which was in a pharmacy vial. They then prescribed Lorazepam. She was afraid to take it. She took one instead of two. The dose was 0.25 mg twice daily. The ER did CT scan of chest with Contrast. It was negative for thromboembolism (also reported as CAT scan's negative for blood clots). She had shortness of breath before the vaccination and it got worse. She was managing it though. Outcome of left arm painful, foggy and not clear, did not have much energy/having no energy/low energy was resolving. Outcome of shortness of breath and hyperventilation was not resolved. Outcome of the other events was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-05-07 | nervousness |
she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting ...
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she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting hurting; she is scared; She used to weight 143 pounds 9 months ago, she states she is swelling up.; overall body aches; cramping; eyes had swollen; fever of 101.9°F/temperature like 101.9 degrees, a fever; chills; nausea; wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) as SINGLE DOSE (at the age of 68 years old) for covid-19 immunisation. Medical history included she is on the borderline of Chronic obstructive pulmonary disease (COPD). She was taking breathing medicine, but has been taken off of it, she is doing so well; osteoporosis; osteoarthritis; osteopenia. Concomitant medication included hydrocodone (HYDROCODONE) taken for osteoporosis, osteoarthritis, osteopenia, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On unspecified date the patient experienced feeling chest pain/her chest is sore, headache/her head just starting hurting, she is scared, she used to weight 143 pounds 9 months ago, she states she is swelling up and overall body aches. On 14 Apr2021, she experienced wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker. She wiped this morning, and she thinks it stopped. She felt cramping. It started light pink, then a couple days ago it was darker. She was a walk in patient at the clinic to be checked out. She lives alone, has no companion for a sex life, she had no new medications. She went to her physician yesterday 22Apr2021, and had a pap smear and blood draws. Her MD told her to take Airborne around the time of the second vaccine. On 16Apr2021 she experienced nausea. On 22Apr2021 the patient experienced eyes had swollen, fever of 101.9°F/temperature like 101.9 degrees, a fever, chills. On 23Apr2021 the patient experienced cramping.The headache has been on and off all weekend. She felt she was dying. The worst yesterday. She read all the Covid symptoms and all her symptoms point toward Covid. She feels like she has Covid from unknown date.She has chest pain and tries to ignore it, but she can't. She has to go get her pain pills because her head just starting hurting.The patient underwent lab tests and procedures which included body temperature: 101.9 degrees fahrenheit on 22Apr2021, blood test: unknown results on 22Apr2021, pap smear: unknown results on 22Apr2021, weight: 143 lbs on 9 months ago. Therapeutic measures were taken as a result of overall body aches. She took gas pain pills, allergy relief pain pills because her whole body hurt. She has been applying warm towels to her eyes to help with swelling. Outcome of fever of 101.9°F/temperature like 101.9 degrees, a fever, chills was recovered on 23Apr2021. Outcome of eyes had swollen, headache/her head just starting hurting, nausea, wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker was recovering. Outcome of feeling chest pain/her chest is sore was not recovered. Outcome of she feels like she has Covid, she is scared, cramping, he used to weight 143 pounds 9 months ago, she states she is swelling up, overall body aches were unknown.
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| 68 | 2021-05-10 | feeling abnormal |
I started having parathesoas of bilateral lower extremities the evening of my second dose.; The next...
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I started having parathesoas of bilateral lower extremities the evening of my second dose.; The next day I saw my pop and my pulse and blood pressure were elevated.; The next day I saw my pop and my pulse and blood pressure were elevated.; I am also having headaches; stuffy nose; sinus pressure; brain fog; my vision is blurry; tinnitus; This is a spontaneous report from a contactable Nurse (Patient). This 68-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Ec3302) via an unspecified route of administration, administered in left arm on 03Feb2021 at 08:15 AM (at the age of 68-years-old) as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EI8982) via an unspecified route of administration, administered in left arm on 15Jan2021 at 08:00 AM as single dose for COVID-19 immunisation. Patient received no other vaccine in four weeks prior vaccination and was not tested for COVID prior vaccination. The patient medical history included known allergies like airborne allergies, grasses, molds, trees, pollen, dust and had controlled hypertension. Concomitant medications included Losartin 50 mg. On 03Feb2021 (at evening, same day of vaccination), patient started having parathesias of bilateral lower extremities. Patient saw pop and pulse rate and blood pressure were elevated. This had continued for the past five days. Patient also had headaches, stuffy nose, sinus pressure, brain fog, vision was blurry and tinnitus. Patient not tested for COVID post vaccination. Outcome was not recovered for all the events.
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| 68 | 2021-05-24 | feeling abnormal |
After 1st shot - day 9 syncope at 5:00 am fell and hit head. Sought ER treatment. General symptoms...
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After 1st shot - day 9 syncope at 5:00 am fell and hit head. Sought ER treatment. General symptoms, dull headache, stomach upset, weak, jittery feeling, heart pounding. After 2nd shot - waves of malaise come and go - generally feel poor in every way. Dull headache, stomach upset, jittery. mild dizziness, weakness, feel faint.
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| 68 | 2021-05-25 | insomnia |
rings of redness around my wrist and beneath my arm; sick; tired; burning; Worse allergy; When the i...
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rings of redness around my wrist and beneath my arm; sick; tired; burning; Worse allergy; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; When the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear; keeping me awake; I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas.; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 04:00 (Batch/Lot Number: ENO273) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies: Aspirin. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). On 04May2021 04:00, I have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. On 04May2021 16:45, When the itching and hives around my writs, neck, forearms, eyes, palms front and back/ hives in the arms, neck would disappear> I tried all kind of ointments and antihistamines. This has being going on for 10 days. On an unspecified date, rings of redness around my wrist and beneath my arm, tired, burning, Worse allergy. Hives around both writs, on forearms, neck, eyes, inside palm of hands. It is awfully itchy, burning and unbearable, keeping me awake. Tried Benadryl, several steroid creams, the patient is still suffering after 10 days. Therapeutic measures were taken as a result of when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (urticaria), when the itching and hives around my writs, neck, forearms, eyes, palms front and back would disappear (pruritus), i have an itchy rash around my wrists, underneath my breasts and on my forearms that is spreading further around these areas. (rash pruritic), rings of redness around my wrist and beneath my arm (erythema), keeping me awake (insomnia): Benadryl, Loratidine, Trimcinolone Acetonid + Fluo, Benadryl Allergy Antihistamine 25 mg gels tablets. The outcome of the event sick, tired, burning, Worse allergy was unknown, while not recovered for the other events. Follow-up attempts are completed. No further information is expected.
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| 68 | 2021-05-25 | nightmare, excessive sleepiness |
felt the prickling and tingling in her chin and neck noting that it was only on her skin; rash / it ...
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felt the prickling and tingling in her chin and neck noting that it was only on her skin; rash / it as one solid circle that was about four inches, slightly raised, warm to the touch and bright red; pain; loss of taste and smell; loss of taste and smell; sit down and fall asleep; Sore ears; woke up like she couldn't breathe; when she swallowed it was irritated; pressure in her throat and ears; Nausea; Generally unwell; Sore Arm; Large, Red, Hot, Swollen, Painful area on Injection Arm; Large, Red, Hot, Swollen, Painful area on Injection Arm; Large, Red, Hot, Swollen, Painful area on Injection Arm; Sore throat; lethargy; tired; Headache; chills; painful lymph nodes on the left side (injection on the left side) then moved to the right axilla; Prickly Itchy area on left side of neck; pressure in her throat and ears; her arm got sore and in the night it felt like she was shot in the arm; nightmares; Caller stated it felt like she had covid again after the first dose; This is a spontaneous report received from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8734, expiration date: unknown), via unspecified route of administration in the left arm on 04Apr2021 at 12:00 (at the age of 68-year-old) for COVID-19 immunisation. Medical history included COVID-19 had previously in late January/early February 2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had quite a reaction to the first dose of the Pfizer COVID 19 vaccine stating she was told it was because she already had COVID then treated with advil and they went away. Patient felt like she had COVID again after the first dose which went away 2.5 - 3 weeks. Patient felt the prickling and tingling in her chin and neck noting that it was only on her skin. A week later the rash appeared in that area and it was quite red for a few days then it went away and prickling and itching still present used cortisone then changed to Aveeno. Eight hours after the first dose her arm got sore, and in the night, it felt like she was shot in the arm and took Advil and then the circle developed which described it as one solid circle that was about four inches, slightly raised, warm to the touch and bright red. The pain went away, decreasing over time and continued Advil over the next couple of weeks. On 04Apr2021, patient experienced headache, chills but no fever, painful lymph nodes on the left side (injection on the left side) then moved to the right axilla, sore throat and pressure in her throat and ears noting when she swallowed it was irritated and it went away after a few days, lethargy (lasted 1.5 to 2 weeks after the first dose) noting she would have to sit down and fall asleep. She reported that halfway through the day she would feel really tired. She had nightmares after the first vaccine and would wake up in the night yelling and she could not breathe, large, red, hot, swollen, painful area on Injection Arm, Sore ears, generally unwell, nausea and sore arm. Patient had loss of taste and smell but noted that it has not come back since she had COVID. She had the rash on her neck on her skin still bothers her off and on since the first dose. The first dose symptoms were more noticeable. The events were assessed as non-serious. The outcome of felt like she had COVID again after the first dose, nightmares, Headache, chills, painful lymph nodes on the left side (injection on the left side) then moved to the right axilla, Prickly Itchy area on left side of neck, pressure in her throat and ears, when she swallowed it was irritated, pressure in her throat and ears, lethargy, tired, Large, Red, Hot, Swollen, Painful area on Injection Arm (Vaccination site erythema), Large, Red, Hot, Swollen, Painful area on Injection Arm (feeling hot), Large, Red, Hot, Swollen, Painful area on Injection Arm (Vaccination site swelling), Generally unwell was recovered; felt the prickling and tingling in her chin and neck, sit down and fall asleep, Sore throat, Sore ears, woke up like she couldn't breathe was unknown; rash / it as one solid circle that was about four inches, slightly raised, warm to the touch and bright red, her arm got sore and in the night it felt like she was shot in the arm, loss of taste and smell (Loss of taste), loss of taste and smell (Loss of smell), pain was not recovered. The causality for the events large, red, hot, swollen, painful area on injection arm, painful lymph nodes, sore ears, prickly itchy area on left side of neck, nightmares; woke up like she couldn't breathe, chills, no fever, sore arm was related.
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| 68 | 2021-05-27 | insomnia |
hypertension level 2/ 165-170/95/ 190/101; shortness of breath and difficulty breathing; very fast h...
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hypertension level 2/ 165-170/95/ 190/101; shortness of breath and difficulty breathing; very fast heart rate (ranged from 95-99 beats per minute); fever/low grade fever- developed 4-5 days later and has been running 99.7-100.0; headache; stomach pain; nausea; fatigue; dizziness; constipation; bad cold chills; hot and cold; sore throat; no appetite; pain all over; joint aches; muscles aches; stuffy nose; sneezing; runny nose; cant sleep; eye were tearing on and off; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ER8735) as 1st dose, single for covid-19 immunisation. The patient's medical history included allergic to ibuprofen. The patient's concomitant medications were not reported. Patient experienced multiple side effects after the first dose. Some of those side effects she experienced shortly after, within 2 hours, and some of them she has continued to experience. She states that within 2 hours of receiving her first dose she experienced shortness of breath and difficulty breathing, very fast heart rate (ranged from 95-99 beats per minute per a pulse oximeter that she carries with her) and hypertension level 2, her baseline is 116-125/70-80 but since the shot she has been high 165-170/95. It was 190/101 2-3 hours and the next day right after the shot; it was super high, this is still going on. The other side effects that she has been experiencing as follows: fever/low grade fever- developed 4-5 days later and has been running 99.7-100.0; headache that gotten better but she still has them every day and takes Tylenol; stomach pain, nausea, fatigue, dizziness, diarrhea started 2 days after the shot, it stopped for a day, then started again for a day or two, stopped for a day, and then started again and went on for 9 days straight; and has constipation, bad cold chills, hot and cold, sore throat, no appetite (ate only lunch can't eat dinner) comes and goes; pain all over, joint aches, muscles aches. Up until morning on 14May2021 still had chills, extreme fatigue, store throat and stuffy nose, sneezing like no tomorrow, one minute will have a runny nose and the next it will be stopped up and stuffy. She can't sleep but very tired. Her eye were tearing on and off, had a runny nose, throat was sore and is every morning so she drinks honey hot water, and she had a cold and has been sneezing for the last 2 weeks. The first time was 2 days after the shot she went to urgent care because she couldn't breath and had all the symptoms, except diarrhea, and she wanted to be tested for COVID. They did a rapid and PCR and they were negative. She has had several rapid and PCR COVID test and all have been negative. On 09May2021, she went to the emergency room but was not admitted trying to find out why she was having these symptoms. She was given steroids and an inhaler to treat her symptoms. She has had an echo cardiogram, EKG, chest x-ray, sonogram of her stomach, blood tests, urine tests, and 9 covid tests all of which were negative and could not explain why she has been feeling the way that she feels. Patient was given Irbesartan when blood pressure high, azithromycin 250mg for 6 days which is also by Sandoz, albuterol sulfate inhaler 200puffs that is manufactured by Par, a steroid nose spray called Fluticasone Propionate 50mcg manufactured by Apots corp. The shortness of breath, stomach pain, nausea, Chills, hot and cold, no appetite, was not recovered, headache, fatigue, dizziness, was recovering, diarrhea was recovered, other event outcome was unknown.
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| 68 | 2021-05-28 | feeling abnormal |
Vaccination site pain left deltoid; joint pain, especially right shoulder joint where I have bursiti...
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Vaccination site pain left deltoid; joint pain, especially right shoulder joint where I have bursitis; joint pain, especially right shoulder joint where I have bursitis; fatigue; chills (freezing my ass off); a little headache; back pain; I also felt like I had smoked some good weed; This is a spontaneous report from a contactable Other HCP (reported for herself). A 68-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiry date was not provided) via an unspecified route of administration in the left arm deltoid, on 29Jan2021 at 08:45 (at the age of 68-years-old) as a single dose for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Medical history included anxiety, depression and allergies to sulfa drugs. Concomitant medications included aciclovir sodium (ACYCLOVIR), venlafaxine (VENLAFAXINE ER), bupropion and levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 29Jan2021 at 09:15, patient experienced vaccination site pain left deltoid, joint pain, especially right shoulder joint where have bursitis, fatigue, chills (freezing my ass off), a little headache, back pain and felt like had smoked some good weed. Everything was brighter and sharper especially the trees. No treatment was received. The outcome of all events was resolved. Follow-up attempts are completed. No further information is expected.
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| 68 | 2021-05-28 | feeling abnormal |
The night of the shot (3/8/2021) i felt like I got "hit by a truck". I went to be early and slept th...
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The night of the shot (3/8/2021) i felt like I got "hit by a truck". I went to be early and slept through the night. The next morning, I felt better, but for a slightly sore shoulder at the injection site. The night of 3/11, I woke up to go to the bathroom and felt dizzy and "off", but went back to sleep and slept through the night. The morning of 3/12/2021 I woke up and could not hear ANYTHING in my left ear! I went to a local Urgent Care facility. They treated me for a bacterial infection in my ear and gave me the following medicines: Antivert 25 mg oral tablet: = 1 tab(s) ( 25 mg ), Oral, tid, x 7 day(s), PRN: for dizziness, # 21 tab(s), 0 Refill(s), Type: Acute pharmacy, 1 tab(s) Oral tid,x7 day(s),PRN:for dizziness, 63, in, 03/12/21 18:08:00 EST, 03/12/21 18:0... cefdinir 300 mg oral capsule: = 1 cap(s) ( 300 mg ), PO, q12hr, x 10 day(s), # 20 cap(s), 0 Refill(s), Type: Acute, 1 cap(s) Oral q12 hr,x10 day(s), 63, in, 03/12/21 18:08:00 EST, 03/12/21 18:08:00 EST I continued the medication as directed, but nothing improved. I did secure a family Dr. by then and scheduled an appointment for him to check my ears because I was supposed to fly and was worried about flying with a bad ear. he said my ears looked good and I was OK to fly. Still nothing improved, so upon returning home at the end of April, I got an appointment for an ENT here to check my left ear. After extensive hearing tests, they determined I have "Profound Hearing Loss" in my left ear! I am scheduled for an MRI to see if anything else could be the culprit,. but at this time, they are thinking I the hearing loss as a result of the Pfizer vaccine, since they've treated other patients with the same problem!!! they did say that mine is definitely the worst they have ever seen!!!
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| 68 | 2021-05-28 | excessive sleepiness |
Arm pain (moderate, resolved within 48 hours.) Dizziness (mild, resolved within 48 hours.) Fatigue (...
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Arm pain (moderate, resolved within 48 hours.) Dizziness (mild, resolved within 48 hours.) Fatigue (severe, resolved within 72 hours.) Arthritic hip pain flare up (moderate, when bearing weight, unilateral. Began 72 hours post vaccination, resolved within 5 days of vaccination.) Exacerbation of GERD and nausea (mild, began 72 hours post vaccination, resolved within 5 days of vaccination.) Low grade fever (mild, 2 degrees F above normal basal body temperature for patient, or less - began within 12 hours of vaccination, resolved within 72 hours.) Somnolence (moderate, excessive sleepiness e.g. 3 or 4 hours beyond normal 8 hour sleep requirement daily - began 4 days post-vaccination and resolved within 1 week of vaccination.)
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| 68 | 2021-05-28 | memory impairment |
I had a lapse of memory and was told that I repeated words three times, consistently for approximate...
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I had a lapse of memory and was told that I repeated words three times, consistently for approximately ten minutes; This is a spontaneous report from a contactable other hcp. A 68-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 12:00 (at the age of 68-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included coronary artery disease (CAD) and diabetes. Allergies to medications, food, or other products was reported as NKDA. The patient had received other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received BNT162B2 for covid-19 immunization on 13Jan2021. The patient experienced a lapse of memory and was told that she repeated words three times, consistently for approximately ten minutes on 04Feb2021 at 12:00 pm. No treatment was provided for the events. The event was not serious, and it did not cause life threatening or fatal outcome. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 68 | 2021-06-01 | delirium |
Patient was hospitalized with Delirium on 5/16/21 - 5/18/21. Lab, imaging and EEG did not reveal any...
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Patient was hospitalized with Delirium on 5/16/21 - 5/18/21. Lab, imaging and EEG did not reveal any definitive etiology for delirium
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| 68 | 2021-06-02 | anxiety |
Rash on arms bilaterally; anxiety related to rash; BP 148/78;117/79;129/80; 133/79; 124/76 and 116/7...
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Rash on arms bilaterally; anxiety related to rash; BP 148/78;117/79;129/80; 133/79; 124/76 and 116/77; This is a spontaneous report from a contactable other Healthcare Professional. A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: el3302) via an intramuscular route of administration, administered in right arm on 03Feb2021 10:30 (at the age of 68 years 2 months) as a single dose for COVID-19 immunization. Medical history included allergic reaction: Sulfa-rash, and Chronic or long-standing health condition included hypertension (HTN). Concomitant medications included loperamide hydrochloride (IMODIUM), mometasone furoate (FLONASE), pancreatin (CREON), valsartan and oxybutynin; all was taken for an unspecified indication, start and stop date were not reported. Patient did not have an adverse event following any previous vaccine. On 03Feb2021 11:00 the patient experienced rash on arms bilaterally, and some anxiety related to rash. There was no other prior illness at the time of vaccination and up to one month. The patient underwent lab tests and procedures which included: on 03Feb2021 at 11:05 am blood pressure (BP): 148/78 (unit not reported) and heart rate (HR): unknown result, at 11:10 am BP: 117/79 and HR: 69 (unit not provided), at 11:15am BP 129/80 and HR: 75. Benadryl elixir 12.5mg/5mL administered at 11:15am per oral. Vital Signs included: 11:20am BP: 133/79 and HR: 67, at 11:30 am BP: 124/76 and HR: 69; Symptoms of rash disappeared at 11:30am and at 11:45am BP: 116/77 and HR: 63. Oxygen saturation stayed at 97 - 99% the entire time. Benadryl elixir 12.5mg/5mL administered at 11:15am PO. Patient reported feeling fine, Patient was released to home at 11:45 with spouse driving car. Patient told to follow up with ER or PCP If symptoms reoccur. The patient was resolved from the events on 03Feb2021. Follow-up attempts are completed. No further information is expected.
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| 68 | 2021-06-02 | anxiety |
Patient reports anxiety. increased heart rate. vitals obtained. heart rate 75 oxygen level 97%. pati...
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Patient reports anxiety. increased heart rate. vitals obtained. heart rate 75 oxygen level 97%. patient asked to lay down. water offered monitored for 15 to 20 minutes. Patient became fine and drove down.
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| 68 | 2021-06-02 | feeling abnormal |
headaches that stopped her in her tracks; she felt like she had the flu; weakness in her muscles; Sh...
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headaches that stopped her in her tracks; she felt like she had the flu; weakness in her muscles; She is tired; feels like she needs to lay her head down by lunch time; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7533 and Expiration date was not reported), via an unspecified route of administration in left arm on 08Apr2021 (at the age of 68-year-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Prior Vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. The patient medical history included joint pain and arthritis. The patient historical vaccine she reports maybe a sore arm with the flu vaccine. She's had her shingles and pneumonia vaccines and never had any problems. NDC/Lot/Expiry for the flu vaccine not known. The sore arm is not even anything she would have been concerned about, there's no issue with a sore arm. The concomitant medications included levothyroxine sodium (SYNTHROID) and celecoxib (CELEBREX). The pharmacist told her to call Pfizer and report her symptoms and side effects. She and her husband both had their first Covid 19 vaccine on 08Apr2021 and she was fine for a few days. Then she noticed that she was getting headaches that stopped her in her tracks. The headaches would last a while then ease up. Then, in her muscles, she felt like she had the flu. She kept thinking her symptoms will work their way out of her system, but it's been constant. She hasn't received her second Covid 19 vaccine because honestly, she's afraid. She's still having headaches every day and weakness in her muscles. She's tired. She's usually energetic, she's a grandmother and she has many duties as a grandmother but now she feels like she needs to lay her head down by lunch time. She would like it known that her symptoms aren't debilitating or keeping her down or at home all the time. Sometimes she just has to stop in her tracks and rub her head a little bit. The napping and tiredness are not how she usually is but none of this is debilitating. Her symptoms haven't gotten worse or better, it's staying about the same. She has not taken anything different that would have affected the vaccine. She hasn't reported her symptoms to her primary healthcare provider. She thought her symptoms would go away. She hasn't been to the emergency room or any medical care facility. The outcome of the event was reported as not recovered.
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| 68 | 2021-06-02 | excessive sleepiness |
The day after I received the vaccine, I had a sore arm, dizziness, chills, heart palpations, extreme...
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The day after I received the vaccine, I had a sore arm, dizziness, chills, heart palpations, extreme fatigue, stiff neck, tingling and creepy-crawly feelings in my torso, arms, up my neck, into my head, and thighs . The dizziness was so intense, I was unable to drive, or even walk without hanging on to something. I slept most of the day. These symptoms have continued for 21 days.
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| 68 | 2021-06-03 | insomnia |
Lost voice; Lose of appetite; Feet and legs very swollen; Muscle aches; Headache behind right eye; F...
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Lost voice; Lose of appetite; Feet and legs very swollen; Muscle aches; Headache behind right eye; Fever for one day(temp unknown); Not sleeping at night; Tight vocal cords; Feel lousy; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199 Dose number: unknown) as a single dose via unspecified route of administration in the left arm on 05Mar2021 at 16:30 PM for COVID-19 immunisation. The patient's medical history included high blood pressure and high cholesterol. Concomitant medications included venlafaxine, lisinopril and atorvastatin all for unknown indications from unknown dates. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient had no symptoms associated with COVID-19 and not had a COVID-19 test. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Mar2021, the patient had headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night. Therapeutic treatments included ProAir Inhaler and advised to drink lots of fluids. Events lead to doctor or other healthcare professional office/clinic visit. Clinical outcome of the events headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night were reported as recovering/resolving. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-06-03 | insomnia |
sore ribs; sleep loss; Sinus congestion; Headache; Cough; Sore throat.; cough worsened; This is a sp...
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sore ribs; sleep loss; Sinus congestion; Headache; Cough; Sore throat.; cough worsened; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot: EN6207) via an unspecified route of administration in the Left Arm on 14Mar2021 at 13:30 (at the age of 68-years) as a single dose for COVID-19 Immunisation. Medical history included Neuropathy in feet, Seasonal allergies and Corn products. The patient previously took Caffeine and experienced allergy . Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Zolpidem (MANUFACTURER UNKNOWN), Doxepin (MANUFACTURER UNKNOWN), Alendronate (MANUFACTURER UNKNOWN) and Multivitamins (MANUFACTURER UNKNOWN) and Flute. Since the vaccination, patient had not tested positive for COVID-19. On 14Mar2021 at 19:30, the patient had experienced sinus congestion, headache, cough and sore throat and cough worsened. Four days later, patient still had sinus congestion, headache and cough which had resulted in sore ribs and sleep loss. Therapeutic measures were taken as a result of sinus congestion, headache, cough, cough worsened, sore throat, rib pain, sleep loss and included treatment with aspirin, drinking hot liquids, applying warm compress and benedryl, but it did not help with congestion. The clinical outcome of sore throat was recovered, of the sinus congestion, headache, cough, rib pain, sleep loss were not resolved and of cough aggravated was unknown. No follow-up attempts are needed. No further information is expected.
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| 68 | 2021-06-07 | confusional state |
This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202, Expiration date was not reported), via intramuscular route in the Arm left on 24Feb2021 15:50, as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history included Mitral valve prolapse in 2005, Colon cancer in 2016, 2016 Colon cancer sigmoidectomy allergic reaction to the chemo, Chemo 6 months from March 2016 to 16Aug2016; whole body constricted including throat closing; Allergy, L knee pain Arthritis and Constipation. Family medical History included: Father Side of family- Heart disease, diabetes and Mother Side- Crohn's disease, colon cancer. The patient's concomitant medications included ibuprofen (IBUPROFEN) for L knee pain arthritis twice daily by oral from 2016 and still ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, 1 dose per day by oral route, every night from 2017 and still ongoing; plantago ovata (METAMUCIL [PLANTAGO OVATA]) for Constipation by oral from 2018, PRN (as needed). The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER2613, Expiration date was not reported), via intramuscular route in the Arm left on 17Mar2021 15:50, as 2nd DOSE, SINGLE for COVID-19 immunization. The patient stated that she had 1st shot in her lunch hour. The patient stayed in hospital for 1/2 hour for any reaction she might have because she had a chronic reaction to chemotherapy since 2015, later clarified to 2016. She left and it takes 20 minutes for her to get home and back to work, and then her arm injection site was tingling with numbing to her fingertips. she got to work and it was so busy she jumped in working, then a little while later saw she had a bruise to the top of her hand where the wrist meets the top of where her hand starts, about the size of a fifty cent piece. She says she knows she didn't hit it, she would have felt the tingling if she had. She said that her bruise is starting to go away. She said that she called her pharmacy and they suggested for her to go to the urgent care, which she did. She says the urgent care said they hadn't heard about bruise like this. She also has a headache, is nauseous, has pain at the injection site, is feeling yucky, and has tiredness. She says the provider at the urgent care suggested and said that she had the injection and chose to take the next day off work, and that she had same symptoms though she didn't have a bruise. She said that her vaccine card has a sticker on it that has first dose, product name, health provider facility, though it was given at a supermarket or grocery store. She said that her numbness and tingling are getting better, she just feels fatigued and tired. She says she is sensitive to stuff anyway. Historical AE/PC: Patient said she doesn't remember the name of the chemotherapy that she had a chronic reaction to and doesn't have the NDC/LOT/EXP to provide from it. She says she was gonna compare ingredients after she got the injection to see if there was anything similar. She says that the urgent care said her BP was high when they took that, then said just her excitement of having done, she says that hers is never high. She said she hadn't eaten since breakfast, though she doesn't know whether that would have anything to do with that, she didn't feel well, and still doesn't so she didn't go to work. The urgent care said if anything else happened to go back there or to emergency room, like if she had shortness of breath or was feeling more of what she had. On follow up(09Apr2021): On 24Feb2021, she noticed her left arm injection site where she had the shot was feeling numbness with tingling to her fingertips on the whole arm. On an unspecified date the patient got back to work and noticed that the top of her left hand was bruised about a size of fifty cent piece at wrist, very wined because she doesn't remember bumping it anywhere. Then she started feeling nausea, confused, headache, Injection site pain and she just feels fatigued and tired. She gave her daughter's phone number to one of her co-worker's and told her, if anything happens to her, to call her daughter. The patient took the next day off from her job because she had no energy. She went to urgent care after next. she didn't feel well, urgent care said her BP was high. All the events were non-serious. The patient underwent lab tests and procedures which included bp was high, blood pressure increased: 153/95, blood pressure increased: 120/80- Normal , blood pressure increased: 160/77 on 07Apr2021, body mass index: 23.56 on 24Feb2021, body mass index: 23.38 on 07Apr2021, body temperature: 97.6 degree Fahrenheit on 24Feb2021, body temperature: 97.5 degree Fahrenheit on 07Apr2021, heart rate: pulse 96 on 24Feb2021, heart rate: pulse 85 on 07Apr2021, oxygen saturation: 98 % on 24Feb2021, oxygen saturation: 97 % on 07Apr2021, respiration: 15 on 24Feb2021, respiration: 20 on 07Apr2021, COVID-19 test: negative on 15May2020. The outcome of the event injection site paraesthesia, hypoesthesia, contusion was recovering, other events are unknown. Follow-up (09Apr2021): New information received from a contactable consumer in response to HCP letter sent which includes: Patient's medical history, family history, lab data and narrative updated. Follow-up (18May2021): New information received from a contactable consumer in response to HCP letter sent which includes: concomitant drugs details and lab data updated. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-06-07 | confusional state |
I had all the symptoms when I had COIVD, shortness of breath, severe back problems from neck to pelv...
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I had all the symptoms when I had COIVD, shortness of breath, severe back problems from neck to pelvic, and confusion.
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| 68 | 2021-06-07 | disorientation, hallucination, amnesia |
Within an hour I wasn't feeling well. My stomach was in knots and I felt nausea. My arm was hurting ...
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Within an hour I wasn't feeling well. My stomach was in knots and I felt nausea. My arm was hurting a little but I was ok. 9 days later I threw up a lot and I don't normally throw up. I couldn't move. I was seriously ill. I didn't know where I was, my family came and took care of me. I was so sick, I couldn't get back to bed. I was hallucinating, lost of memory
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| 68 | 2021-06-07 | feeling abnormal, memory impairment | Brain fog; memory problems; slower thinking and movements; general fatigue |
| 68 | 2021-06-07 | feeling abnormal |
She is not dizzy but has a weird feeling; Head hurt: This morning her head felt funny; Her temperatu...
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She is not dizzy but has a weird feeling; Head hurt: This morning her head felt funny; Her temperature is 99; She feels wobbly when she gets up.; cough; She has a cough and post nasal drip in the back of her throat; This is a spontaneous report from a contactable other hcp (patient) who an assistant nurse reporting about herself. A 68-year-old female patient (68 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date were not reported), via an unspecified route of administration on 25May2021 as single dose for COVID-19 immunisation. The patient's medical history included ongoing sinus problem and abnormal conditions of blood pressure and blood cholesterol since an unspecified date. She was allergic to dust, pollen, and cockroaches. She could not take Tramadol, because every time she did, she passed out. She reported that she had received two shots for influenza immunisation (It was a long time between, not 2 at the same time). She mentioned that she had Covid back in December (unspecified date) but had already recovered from it. The patient's concomitant medications included acetylsalicyclic acid (ASPIRIN) taken for unspecified indication, Fluticasone propionate (FLONASE ; does not have an NDC, lot, or expiration date) taken for cough and sinus problems. She also took her cholesterol pill (for abnormal blood cholesterol condition) and unspecified vitamin supplements at night. She was on unspecified blood pressure medication (pills) for abnormal blood pressure. Following the vaccination on 25May2021, the patient experienced cough and had postnasal drip in the back of her throat. Her body temperature was reported as 99 degree Fahrenheit. Her head hurt after she had the shot. Next day morning, on 26-May-2021, the patient experienced wobbly when she got up and her head felt funny. She was not dizzy but had a weird feeling. She was drinking a lot of water. She wasn't throwing up or anything. She added that she did not experience shortness of breath and light-headedness. She stated that she had allergies and sinus problem and took medicine for that. The patient usually took TYLENOL (unspecified formulation and dosage regimen) for her headache which would wear off. But this time she took Paracetamol (TYLENOL FORTE, unspecified formulation; Lot: ABA115, Expiration date: Jan2023) 2 doses but her head still hurt at the time of report. She also took (Over the Counter) medication Fluticasone propionate (Flonase; nasal spray; unspecified NDC, lot, or expiration date) that morning. She had Listerine and spitted up the mucus. She would even take her blood pressure pill at night because she didn't like the feeling. She didn't like any pill to make her dizzy. She also took her cholesterol pill and her vitamin at night because she didn't want it to make her sick. She clarified that she felt chill because she had the AC on. It was cold in her apartment. It was 90 degree Fahrenheit outside. The patient's lab tests, and investigational procedures included lung function test after she had Covid in December and the result was reported as everything was good until she got the shot. On 25May2021, her body temperature was 99 degree Fahrenheit (but as per the patient, it was just because she just came out of the shower), blood pressure was good at 118/84 and heart rate was 82. She added that she contracted Covid-19 in December (unspecified date in 2020) from her co-worker where she worked in hospital. Hence, the patient had also tested for SARS-COV-2 antibody test which resulted positive. The outcome of the event of feeling weird was not resolved at the time of report, whereas the outcome of rest of the events was reported as unknown.
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| 68 | 2021-06-07 | insomnia, feeling abnormal |
ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense bur...
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ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain/ Pain in arm; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; could not sleep for 2 nights.; diarreha; numbness in left hand; brain fog; neck is stiff; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Lot Number: EW0183), via an unspecified route of administration, administered in left arm on 17May2021 at 11:45 at age of 68-year-old as single dose for covid-19 immunisation. Medical history included allergies with poly glycol in cosmetics and penicillin, no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included xantofyl (LUTEIN), ascorbic acid/ zinc citrate (ZINC + VITAMIN C), vitamin D. On 17May2021, at 11:45 AM, immediate reaction after shot was done, patient had left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain, patient stayed 30 min, and took a acetaminophen (TYLENOL) during this time. Patient came home drank lots of water, pain and burning increased all day took ibuprofin and kept icing. No relief. 4 hours after injection, numbness in left hand lasted 10 min. During night, patient was tried to get out of bed left foot number for 5 min. Patient had diarreha for 5 days. Pain in arm was extreme immediately, stayed sore for 5 days, could not sleep for 2 nights. Patient also had brain fog and ringing in ears starting 22May2021. Patient still had burning in left side of neck, shoulder and jaw and neck is stiff. Patient took benedryl, tylenol, ibuprofen, iced, and exercised stretched, no relief. The outcome of events was not recovered. The events were assessed as non-serious.
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| 68 | 2021-06-07 | insomnia |
Left arm where injection was given is sore at the site of the injection. If I sleep on my left side...
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Left arm where injection was given is sore at the site of the injection. If I sleep on my left side my arm will hurt for 4 to 6 hours after I awake. If I lean against something my arm will ache where the injection was given. I don't think this is normal. I had the covid vaccination of 04/01/2021 -- 2 months ago and to have my arm hurt is not normal. I have never had pain from an injection of a vaccination. I did not have any pain from my first injection. only the second injection.
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| 68 | 2021-06-07 | mental status changes | Altered mental status |
| 68 | 2021-06-10 | abnormal dreams |
Sleep, very tired; Vivid dreams; Extremely weak; Soreness on arm; Sweat beads developed; Sensation o...
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Sleep, very tired; Vivid dreams; Extremely weak; Soreness on arm; Sweat beads developed; Sensation on both of her hands; chills; Pins and needles; pain, right hip pain, feet pain, joint pain; joint pain; feet pain; This is a spontaneous report from a contactable other hcp. A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 12Feb2021 at 12:00 (at the age of 68-years-old) as 1ST DOSE, single dose for covid-19 immunisation. Medical history included neck surgery from 2015 on an unknown date She had degeneration. Had to have C3 4 5 6 all replaced, ongoing osteopenia Diagnosed with bone scan, Heredity Glaucoma and hormone level abnormal from an unknown date and unknown if ongoing. Concomitant medication included latanoprost taken for Heredity Glaucoma from an unspecified start date and ongoing at 1 drop, once a day [one drop in right each night 0.005% othamlamogic solution], estradiol taken for Low hormones and prevent UTIs via virginal route at 0.5 mL, twice a week from an unspecified start date and ongoing. Patient previously took flu shot and experienced tiredness, sore arm and She got sleepy. On an unknown date in Feb2021 the patient experienced pain, right hip pain, feet pain, joint pain, pins and needles, chills and on 12Feb2021 patient experienced Soreness on arm, Sweat beads developed, Sensation on both of her hands. On 17Feb2021 patient experienced Sleep/ very tired, Vivid dreams and Extremely weak. Caller stated on day 12 the symptoms resolved except for chills from the pelvis down. Caller wanted to know if the second dose could cause the same symptoms to be exacerbated. Mentioned she had surgery on left eye it was so bad with glaucoma so no eye drops needed in left. She had minor symptoms initially. She had soreness in her arm where got injection for 2-3 days. This was like she would have if had the Flu Shot. It was very easy. The soreness started the night got the vaccine, but no redness. About 30 minutes after getting the shot she started to develop little sweat beads on the back of her neck, forehead, and inside of her arms. She also then felt a sensation on both of her hands. To her this was very minor. The sweat beads came and went within just a few seconds. It occurred on her way home from getting the vaccine. Initially confirmed the sweat beads only occurred the 12Feb2021, but later mentioned it may have occurred a day later a couple of times. She always took her temperature and she never had a temperature. It was always 97.4. It was reported that she thought it was all over at first. However, on Day fifth she was hanging pictures in her new home. She was just doing normal household things, nothing big, but she became unusually sleep and tired. She laid down on day 5 and thought she needed a nap. She closed her eyes and was out like a light. She never woke up. During this time she had very weird vivid dreams. She even remembers 2-3 of the dreams she had after she woke up. She was sleeping hard. She felt this was gone and had the best nap of her life. However, she had to wake up after 2 hours because her grandson was coming home whom she has adopted. She wanted to go to the store as well. So she got up and went to the store as well. However, after waking, during that time she felt extremely tired. She felt like she was not really fully awake, but then that feeling went away. When this occurred she was wondering why this was happening. It was day 5 from getting the vaccine and she thought the symptoms should have come and gone by then as most people say on the news, and from reading on smart phone it was just 2-3 days. Also, during this time on day 5, that Wednesday, something else was starting to develop that she had not fully connected yet. She mentioned this part was serious. She was starting to get extremely weak. She was weaker than she should be at her age. She was not weak in her arms at all or her upper body. However, she had a great deal of difficulty getting out of chairs and it got to the point it was very noticeable. However, she did not connect it. She did not know she was supposed to connect it. She was not sure exactly what day these following events started, but she knows she did not have it before in the beginning. Her feet were hurting so badly and she could not stand on them. Her right hip started to hurt like it was a knife going through the joint. The right side was her good leg. She already knows her left leg was weaker than her right leg. She knew her right side was the stronger side. However, this was nothing to keep her from walking 2 hours a day. However, her right hip should have been good, but after the vaccine it became very painful. She also had chills up and down her leg. She thought the chills were gone yesterday and had 100% recovered from it all on day 12, which was yesterday, but she realized while waiting on hold she had the chills again. While waiting on hold for the DSU agent she had chills occasionally, especially right leg and would get some in left leg. It was like legs have been inflamed or joints inflamed. She thought she would have to have hip surgery. She also had pain in pelvic area. The bones there had pins and needles at that time. She had the pelvic pain and would be driving in a car, a nice comfortable car. Her right leg had pins and needles for several days along with hip pain. She had foot pain in both feet. It hurt when she stood and walked, her feet hurt. Yesterday morning when she got up she thought a miracle had occurred. She was able to walk across the floor and did not realize she was even walking. It was like normal again. Everything had gone away like it never happened. She knows in her heart of hearts and after talking to her sister who was a retired pharmaceutical scientist these events are all related to the Pfizer COVID 19 Vaccine and she should report these to Pfizer. She was so happy when they went away yesterday. She was still active and likes to walk. She was able to walk for 2 hours and was not sore when she got home. She was fine. She was like she normally was. Today, she feels normal except the chills in her legs again that was a little bit. She has no pain whatsoever. Yesterday morning it was like the pain had disappeared, like she never had it. She confirmed the pain and pins and needles as recovered with lasting effects as she still has the chills. She hopes and prays the pain never comes back. She was willing to take normal aging arthritic pain if she get it because that was life. The flu shot maybe had tiredness and sore arm. Does not have a lot/exp/NDC to provide. The tiredness was 20-25 years ago. She got sleepy. Outcome of the event chills was not recovered. Outcome of the event Vivid dreams was unknown. Outcome of the events Sensation on both of her hands was recovered on 12Feb2021. Outcome of the event pain, right hip pain, feet pain, joint pain and Pins and needles was Recovered/Resolved with Sequel on 24Feb2021. Outcome of the events was recovered on unspecified date in Feb2021. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events pain,Paraesthesia and pain in extremity cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-01-07 | insomnia |
fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / receiv...
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fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / received the vaccine on 18Dec2020, at that time she only had symptoms of pain; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number CJ1685) via an unspecified route of administration on 18Dec2020 at single dose in the right arm for COVID-19 immunization. Medical history included gum surgery on 29Dec2020. Concomitant medication included amoxicillin trihydrate (AMOCILLINE) from 29Dec2020 post gum surgery. The patient received the vaccine on 18Dec2020. At that time she only had symptoms of pain (onset date 19Dec2020). On the night of 04Jan2021, she had chills and needed 3 blankets and 2 robes. Three hours later her chills were gone and she had a temperature of 105 degrees (fever onset date 05Jan2021). She also had a headache (headache onset date 04Jan2021). She took two paracetamol (TYLENOL) and was unable to sleep until 3:30am. She woke at 9am (05Jan2021). She checked her temperature again and it was 99.2. This was after going 12 hours without taking paracetamol. Then she had body aches (body aches onset date 04Jan2021) but no headache. She thought she was dehydrated and she drank some water. Her headache was gone. She was scheduled for the second vaccine on 08Jan2021. She was told that her body would respond stronger and the symptoms be worse since she responded 17 days after getting the vaccine. The event pain (after vaccination, on 19Dec2020) was resolved on 19Dec2020, chills was resolved on 05Jan2021, fever was resolving, headache was resolved on 05Jan2021, body aches was resolved on 05Jan2021. The outcome of "unable to sleep" and "she thought she was dehydrated" was unknown.
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| 69 | 2021-01-19 | feeling abnormal |
At 1332, she called into the office to let us know that she was not feeling well after her vaccine. ...
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At 1332, she called into the office to let us know that she was not feeling well after her vaccine. 1331 2 RN's got to her vehicle to assess her. She stated she was feeling "not right", complained of her left arm hurting, a headache, and right ear pressure. Vital signs at 1339 showed a BP of 138/76 done by manual cuff, a pulse was taken radially and was 78 bpm, with a regular rate and rhythm by palpation, respirations were 26 breaths per minute, and her O2 saturation was 99%. 1342 she had episodes of emesis out the side of her vehicle multiple times. 1344 EMS was called. 1347 50mg of IM Benadryl was administered into her right deltoid. EMS arrived at 1349 and care was transferred over at that time. Her husband took her car keys and was driving separate to Emergency Department.
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| 69 | 2021-01-21 | nervousness |
Patient at 1440 patient wasn't feeling right. feeling hot and shaky. BP 149/72. 96% spo2. HR 63 oth...
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Patient at 1440 patient wasn't feeling right. feeling hot and shaky. BP 149/72. 96% spo2. HR 63 other medical conditions was reported as no. but blood sugar was 63. Patient given grape juice and sandwich repeat bs was 102 patient recovered with no further treatment.
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| 69 | 2021-01-25 | sleep disorder |
Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side...
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Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side just behind the injection site. By Sunday afternoon the pain became debilitating and the pain spread to my underarm and the edge of the breast area. I applied heat and rested. The sharp pain interfered with sleep and regular life activities. On Tuesday morning I applied an ice pack, which relieved the pain. After applying ice for two more times, the pain subsided and the swelling under my arm disappeared. I was able to resume normal activities with slight discomfort.
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| 69 | 2021-01-25 | sleep disorder |
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom...
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2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
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| 69 | 2021-01-26 | confusional state |
HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented ...
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HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented with c/o fatigue, fevers, shaking chills, SOB/cough, anorexia, N/V/D for the past 6 days (GI symptoms started 2 days ago). Husband reports she has also had periodic confusion during this time. She received her second COVID vaccine 7 days ago and symptoms started the following day.
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| 69 | 2021-01-26 | sleep disorder |
first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headac...
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first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headache, felt under the weather. Third day more swelling, redness and headache. Today, forth day, swelling going down still red, no headache and feeling better in general. Took tylenol for headache and pain.
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| 69 | 2021-01-26 | sleep disorder |
Extreme night sweats to the point of wrenching bidding. Would occur they the nite waking me. Never h...
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Extreme night sweats to the point of wrenching bidding. Would occur they the nite waking me. Never had this before.
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| 69 | 2021-01-27 | anxiety | Client states she was feeling anxious after receiving the vaccine. Chielt has a history of anxiety |
| 69 | 2021-01-28 | crying |
Nauseous; Lightheadedness; very Emotional; Crying; This is a spontaneous report from a contactable c...
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Nauseous; Lightheadedness; very Emotional; Crying; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:00 at single dose (Lot number= EL3246, Vaccine location=Left arm) for covid-19 immunisation. Medical history included low thyroid, high blood pressure, reflux disease, anxiety, depression, Allergies: sulfa "caflex". Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included calcium citrate, venlafaxine hcl, pantoprazole, nortriptyline, levothyroxine sodium (SYNTHROID), amlodipine, estrogens conjugated (PREMARIN), paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nauseous, lightheadedness, very emotional, crying on 16Jan2021 09:00. No treatment received for the events. Events result in clinic visit. Outcome of events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 69 | 2021-02-01 | feeling abnormal |
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration in Jan2021 (on Thursday) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller received the first dose of the vaccine on Thursday in Jan2021 and she's felling bad, she couldn't go to work and would like to know what she could do. Had been down ever since. Couldn't get out of bed. Has a temperature. Felt so bad she couldn't go into work today (18Jan2021). Not sure what's going on. Clarified she's referring to the Pfizer COVID-19 Vaccine. Had she known what she knows now she would not have taken it. The patient was hot, sweating, and dizzy. (Facility name) administered the COVID-19 Vaccine. Didn't know if she needs to go get tested. Felt like crap. Felt bad. Hasn't been out of bed in three days. Requested to be transferred. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
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| 69 | 2021-02-01 | impaired work ability |
I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot ...
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I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot that high up. She said in a snide voice it?s still the deltoid and she shot my bursa. The evening of the shot I started having severe arm pain and nausea. The next morning I had right scapula rib pain it was hard to breathe my arm hurt very bad I can hardly lift it I went to work. When I got to work I couldn?t function I was so nauseated with the pain I went home that day and I?ve missed three days total from that event of wrong injection site. The pain has gotten worse I can?t lift my arm left right upper down without pain and it?s going into my neck and down to my elbow now I went to the occupational medical doctor. I told him what happened and he said she gave me the shot am I supraspinatus Bursa and I have an injury to my bursa. I came back for a second visit the next week and he said I have bursitis from that now I can?t raise and use my arm that well at all and I have severe pain 24 seven still and he sent me to a physical therapist starting today 2 to 21. It has gotten worse and my shoulder has locked up three times. I still have ongoing pain 24 seven and I want to report a complaint against the girl who gave my shot I thought she was an LPN but she is a MA. We both work at healthcare clinic. I am a 26 year RN and she did not listen to me and she stuck me anyway against my will.
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| 69 | 2021-02-03 | anxiety |
4 hrs after shot severe hives, itching beginning on arms. Over time hives rest of body. 4 days lat...
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4 hrs after shot severe hives, itching beginning on arms. Over time hives rest of body. 4 days later still have hives. Feel anxious, took benadryl
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| 69 | 2021-02-03 | confusional state, anxiety, feeling abnormal |
at 1128 EMT, (MD), and (PHN) responded to clt in observation area. c/o mild itchiness at vaccinati...
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at 1128 EMT, (MD), and (PHN) responded to clt in observation area. c/o mild itchiness at vaccination site. Vitals taken at 1130 am: BP 110/82 HR 70. PT AxO x4. c/o progression of internal itchiness to left arm and lower body, mild dizziness and confusion/"foggy." 50 mg Benedry PO elixer given at 1135 am. Vitals recheck at 1150 am: 145/90, 80 HR. Clt exhibited s/s anxiety. At 12 pm Pt states feeling better, denies dizziness, states is more focused, denies CP, denies s/s tight throat or swelling. no swelling noted. states itchiness is better. left site at 12 pm, PHN instructed Pt to f/u with PMD in 24 hours.
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| 69 | 2021-02-03 | feeling abnormal |
a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a cons...
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a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the right arm on 15Jan2021 at 15:30PM (at the age of 69-year-old) as a single dose for COVID-19 immunization. Medical history included just sensitivities, not allergies, to NSAIDS and some pain meds. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medication taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on the first day nothing. On 16Jan2021, the second day (as reported), the patient experienced lethargy and a bit of fogginess. The third day, 17Jan2021, the patient had a background headache all day. The events were reported as non-serious. The patient finally took (acetaminophen) TYLENOL before bed, for the headache, waking on the fourth day feeling normal. The clinical outcome of the events lethargy, bit of fogginess, a background headache all day was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 69 | 2021-02-04 | anxiety |
Within 5 minutes there was extreme anxiety followed by swelling of finger, face and feet, , loss of ...
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Within 5 minutes there was extreme anxiety followed by swelling of finger, face and feet, , loss of voice, swelling of throat, Treated with Benadryl, oral steroids, with some improvement over 30 minutes Then worsened with increased throat swelling, numbness of feet. Taken to ER above, treated with Epi injection, Iv solumedrol and pepcid with improvement Sent home after 3-4 hours, Next morning 12 hours after leaving Er Voice better but began to worsen another dose of oral prednisone, benedryl andPepcid taken with improvement
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| 69 | 2021-02-07 | confusional state |
felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoi...
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felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoing congestion in one nostril/stuffiness; felt tired and run down; feeling itchy/Her head, neck and back are very itchy; rash/like a fever type rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3249, unknown expiration), via an unspecified route of administration in the left shoulder area on 16Jan2021 at 11:15 AM at a single dose for COVID-19 immunization. Medical history included COPD (has it for lots of years) and nickel sensitivity. She does not have any reactions to her previous unspecified vaccines but had a normal reaction like sore arm. Concomitant medication included bimatoprost (LUMIGAN). The patient previously received flu vaccine and pneumonia vaccine, both for immunization in 2020 around the end of Sep or beginning of Oct. The patient reported side effects regarding the COVID vaccine and said she was a little confused and unsure if she was having a problem or if she should see a doctor. On 16Jan2021 at 11:15 AM, she had the first dose of the COVID vaccine and afterward she had a lot of effects which were mostly muscle and body aches in Jan2021. She also experienced some ongoing congestion in one nostril but saw this as just more congestion and that she was having to blow her nose more in Jan2021. She did the (app name) report but didn't report the stuffiness. She did report that in the first few days she felt like she was having the onset of pneumonia and felt tired and run down (Jan2021). Two days ago, she started feeling itchy (Jan2021) and she didn't know what it was, she didn't know if she ate something or what. Now she has developed a rash (Jan2021) which is ongoing until now. Her paperwork said the rash would happen right away if it was caused by the vaccine. The patient wanted to know if this is something she should be concerned about and if the rash could appear or started this long after she had the vaccine. Her second dose is due on 06Feb2021. The patient wanted to know if the vaccine contains nickel or any metal substances in it since she had compared her rash to her nickel sensitivity. The patient wanted to know if rash is a side effect from the vaccine and how long it will last. She didn't put rash down for the safety check either as she didn't know if it was caused by the vaccine. Today her rash, she is so itchy. She does have it on her neck and certain areas but not everywhere. It looks like what would happen after a bad fever. It is not raised but is like a fever type rash. She did note that she had an increase dose of a medication eye drops (Lumigan; Lot: T and a 0 or O followed by 544, and NDC: 0023320503. Expiry: Jan2022) around the time the rash started but after getting the vaccine. Her head, neck and back are very itchy. She mentioned that she waited 2 days and did not put this event in the (app name). She would have reported it yesterday, but she didn't get one yesterday. She also noted that it was very dry there and cold and a person is going to get dry skin. She does have an allergic to metal and wondered if that was in the product. In her neck area, it looks just like when she would wear a cheap necklace. No treatments received. The events did not require emergency room or physician office visit. The patient has no prior vaccination within four weeks. The patient had not yet recovered from events rash/like a fever type rash and congestion in one nostril/stuffiness; while unknown outcome for the remaining events.
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| 69 | 2021-02-07 | restlessness | Arm is very sore and itchy. Headache, fatigue, restless. Just did not feel well. Lasted one day. |
| 69 | 2021-02-08 | nervousness |
Approx 10-15 minutes after receiving the vaccine, client started c/o feeling shaky and overall jitte...
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Approx 10-15 minutes after receiving the vaccine, client started c/o feeling shaky and overall jitteriness, and elevated blood pressure. She was monitored for several minutes and started feeling better. She admits to being nervous to take the vaccine and has had several episodes like this before after vaccines. She was steady enough to drive herself home and she went to bed for a few hours and woke up feeling fine except for a sore arm for 2-3 days. Had physical 3 days after this episode and he said she was fine.
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| 69 | 2021-02-08 | sensation of foreign body |
Pt in observation area for ten minutes before describing onset of "lump in throat." Confirmed she ex...
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Pt in observation area for ten minutes before describing onset of "lump in throat." Confirmed she experienced the same issue after receiving the first dose. Took a Benadryl after the first dose and it improved symptoms. No other issues (no redness, rash, hives, difficulty breathing). EMT, took pt's vital signs - all WNL. Pt had oral Benadryl on hand and took one orally. EMT took vital signs again after ten minutes - vitals stable and WNL. Approximately 30 mins after taking oral Benadryl pt reported symptoms better. Pt stayed in observation area for approximately one hour total, stood up and walked out after symptoms resolved.
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| 69 | 2021-02-09 | panic attack |
Pfizer-BioNTech COVID-19 Vaccine EUA Fast Heartbeat - initially after injection but I thought it was...
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Pfizer-BioNTech COVID-19 Vaccine EUA Fast Heartbeat - initially after injection but I thought it was a panic attack. But it subsided and I drove home. About 1.5 hours after the injection I realized my heart was pounding. I felt the pounding/racing heartbeat for about another hour. My BP was normal, pulse was 90 but it has often been 90 on other occasions.
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| 69 | 2021-02-10 | confusional state |
Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength ...
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Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength headaches, ripping pain in chest, ribs, upper back, shoulders, neck, head. I could not sit or lie down comfortably. I saw Dr. on February 1 who ordered a CT scan which was clear. He prescribed Prednisone and Robaxin 500 mg. I saw Dr. again on February 4 at which time most of the pain subsided but my body was very sore. It is now February 11 and I still feel a bit of cloudiness, but am much better. Hopefully, I'll feel like myself within a few days.
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| 69 | 2021-02-10 | feeling abnormal, agitation |
About 12 hours after I had severe chills and fever up to 102.2, muscle pains & very slight headache ...
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About 12 hours after I had severe chills and fever up to 102.2, muscle pains & very slight headache Symptoms lasted 24hours EXCEPT for a feeling in my head that I have had when getting off my antideprssant--sort of fuzzy/shaken feeling. Wondering if it's making my meds for that ineffective.
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| 69 | 2021-02-10 | feeling abnormal |
Within a few seconds I felt very sleepy, my face became numb which began spreading to my mouth. Ment...
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Within a few seconds I felt very sleepy, my face became numb which began spreading to my mouth. Mentally spaced-out, weak and unable to drive my car even a few yards. Requested ambulance and was taken to emergency room. EMT administered Intravenous Benadryl. In hospital Pepcid was administered immediately. The numbness eventually spread throughout my body and I felt twitching/trembling, particularly my mouth and jaw. My feet felt like they were being pulled away from my body. After testing was complete, Solu-Medrol was administered and all symptoms disappeared immediately.
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| 69 | 2021-02-10 | loss of personal independence in daily activities |
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache...
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deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
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| 69 | 2021-02-11 | feeling abnormal |
Within 5 minutes I developed a strange feeling in my head, not full blown dizziness but more of a li...
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Within 5 minutes I developed a strange feeling in my head, not full blown dizziness but more of a light headedness with a fullness to both eyes and a pressure sensation behind both of my eyes. After the 1st dose I was fine for the 30 minutes of observation and about 5 minutes after leaving I had a similar reaction but not nearly as intense, It lasted for about 1 hour, the reaction to the second dose lasted 3 1/2 days progressively getting a little better each day.
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| 69 | 2021-02-11 | feeling abnormal |
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he...
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Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
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| 69 | 2021-02-11 | impaired work ability, confusional state |
Patient experienced dizziness and a burning sensation in chest and throat within minutes of this inj...
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Patient experienced dizziness and a burning sensation in chest and throat within minutes of this injection, that initially resolved only to reoccur later that afternoon in conjunction with chills, body aches, headache. Patient was feeling so bad with confusion and dizziness the next morning such that she was unable to get out of bed and had call in sick to work. Patient symptoms continued for the next week and she was unable to return until 19 January (but still symptomatic and short of breath on exertion). Patient was tested for COVID-19 infection on 19 January which was negative. Patient then followed up with her primary care doctor the following and retested for COVID-19 (also negative again). Primary care provider performed basic labs without revealing any abnormalities. Patient does not feel back to normal at this time - she continues to have intermittent chills and the headaches only stopped in the past 7 days.
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| 69 | 2021-02-12 | sleep disorder |
Rapid heartbeat lasting about two hours, started about eight hours after injection, upon retiring. S...
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Rapid heartbeat lasting about two hours, started about eight hours after injection, upon retiring. Started after lying down trying to sleep. No other side effects. Did not report this at the time and was normal in the morning.
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| 69 | 2021-02-13 | hallucination | 104.5 degree fever, rigors, hallucinations, severe joint pain, headache, muscle weakness |
| 69 | 2021-02-13 | nightmare |
Began with general malaise. One night of transient pains perceived as white balls of pain during nig...
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Began with general malaise. One night of transient pains perceived as white balls of pain during night of Feb 9. Exhaustion and fever of 100.4 and chills occurred on February 10, and I spent 4 hours in bed during the day. Transient pains again with strange nightmarish perceptions during night of February 10, Some shortness of breath on February 11, and onset of fairly severe chest, lung, and middle body pain, This pain intensified during night of Feb 11, and continued through February 12, but energy returned. Pain diminished by February 13, when I was almost feeling normal again.
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| 69 | 2021-02-14 | anxiety |
The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, hear...
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The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, heart was beating harder and faster, stomach felt upset, she was burping a lot Feb 8th went to primary care doctor. BP was 175/90. She felt dizzy and lightheaded, ringing in ears was louder than usual She gave another BP med to take, but she didn't take it. Instead took an extra of hr own propranolol. Yesterday was the first day the sxs were better. Other than taking the extra propranolol on Feb 8th, she just rested 2/11/21 is the first day the tiredness has let up
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| 69 | 2021-02-15 | disorientation |
HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HY...
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HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HYPERSENSITIVITY TO LIGHT AND NOISE, LACK OF URINATION, BOUTS OF DIARREAH, CHILLS WITH SKIN ICE COLD TO TOUCH, FREEZING FEET, UNABLE TO DRINK LIQUIDS; COULD NOT EAT FOR 3 DAYS; NO FEVER
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| 69 | 2021-02-15 | sleep disorder, restlessness |
Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at in...
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Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at injection site, red injection site that is about 4? long, itching injection site. Injection site still red, swollen and itching. Taking Tylenol and using topical Benadryl for itching. Appetite returned on 2nd day. Fever, fatigue and chills lasted 1 day.
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| 69 | 2021-02-16 | anxiety |
Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funn...
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Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.
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| 69 | 2021-02-20 | sleep disorder |
5 hr after second shot ate dinner and had diarrhea. Felt ok and then went to bed. 1 AM awoke with st...
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5 hr after second shot ate dinner and had diarrhea. Felt ok and then went to bed. 1 AM awoke with stomach and back aching and cramping. Unable to find comfortable position. Nothing warranting intervention but clearly too uncomfortable to sleep. Some tingling on back of arms and thighs; similar to flu. May have slept briefly and woke saturday to similar tummy pain. No diarrhea or vomiting. Slight headache. Symptoms began to disappear soon with stomach ache dissipating throughout day. Able to sleep fine saturday night and 100 percent good today. Almost no symptoms after shot one; by the way.
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| 69 | 2021-02-21 | anxiety, irritability, depression |
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ...
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After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
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| 69 | 2021-02-21 | sleep disorder | During sleep time kept waking up and feeling like I was going to vomit. Headache. |
| 69 | 2021-02-23 | anxiety, nervousness, insomnia |
The itching was located just below the injection site at a spot where the skin was a little red; The...
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The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
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| 69 | 2021-02-23 | sleep disorder |
Injection site still sore two weeks after injection. Soreness causes sleep loss and pain seems to be...
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Injection site still sore two weeks after injection. Soreness causes sleep loss and pain seems to be circular around injection site (like a ring around my arm)
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| 69 | 2021-02-25 | anxiety, nervousness |
Client c/o dryness of mouth, flushness to face, proceed by hyper salivation (spittle). Client verba...
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Client c/o dryness of mouth, flushness to face, proceed by hyper salivation (spittle). Client verbalized that she felt anxious and nervous about taking vaccine but started to feel decrease in sensation. Client seen by EMS and vitals are BP-168/89, Heart Rate76, O2-97. Client then cleared by EMS to go home.
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| 69 | 2021-02-25 | anxiety |
February 21, 2021 around 4 pm, a woman on the passenger seat of a car, driven by her husband began ...
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February 21, 2021 around 4 pm, a woman on the passenger seat of a car, driven by her husband began feeling ? dizzy?. I was approached by our CIO to see her immediately. Another Nurse came to the rescue and we both assessed the patient. She was awake, alert, oriented but anxious and stating she's dizzy. The back of the seat was lowered down for her comfort and blood pressure was taken. It was 172 /100 mmhg. PR = 72 , Temp = 97.5. RR = 18. Two other RNs came to help. The patient was conversant, her husband was upbeat and being funny. Pt started to play with her dog from the backseat reaching for it. The patient was talking but I decided to tell patient to relax since vital signs will be taken again. BP repeated after 6 minutes and its now 155/100, PR= 75, RR=19, TEMP= 97.3, 02 Sat @89 % . Pt?s hands were cold now. O2 Sat was also hard to get a good reading on all of her fingers. Called Dr. Cat Forest and she came to the scene comforting patient while vitsal signs were repeated again after 5 minutes after they were taken Now getting BP= 55/110 mmhg, PR: 80, Temp 97.2 and O2 Sat still at 89% Pt was adviced to go the ER after the Patient?s O2 Sat stayed at 89% and also after finding out that patient haven?t had any physical for two years and that patient doesnt check her blood pressure. Pt and her husband were counselled on the importance of getting regular check up especially at her age of 69 years old. Husband drove patient to the ER per order. Called patient on Monday, 2/23 and Tuesday, 2/24 with no answer. emailed patient and patient answered back and she said that she went to the ER with her husband that day and was discharged and feeling better and wanting to thank the staff for the way she was taken cared of and hoping they will be there for her second dose when she comes back.
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| 69 | 2021-02-25 | disorientation |
disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a co...
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disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247, expiry date: unknown), via an unspecified route of administration on 23Jan2021 15:15 (at the age 69 years old) at a single dose, in the right arm for covid-19 immunisation. Medical history included fibromyalgia and polymyalgia. The patient's concomitant medications included other medications both prescribed and over the counter. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination. On 24Jan2021 at 0900, the patient experienced disorientation that was present then went away and the patient seemed to be okay; low oxygen saturation and acute congestive heart failure (CHF). On Monday, she was disoriented again and went to emergency room (ER). All the events resulted in emergency room visit and hospitalization for seven days. The patient underwent lab test and procedures which included nasal swab covid test on 25Jan2021 which showed negative. Outcome of all the events was recovered on unspecified date.
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| 69 | 2021-02-25 | insomnia, confusional state |
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th...
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Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
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| 69 | 2021-02-25 | memory impairment, feeling abnormal |
After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, sl...
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After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, slept all day, very weak, couldn?t remember what happen rest of day after booster (2-24) or then next day during sever reaction.(2-25) Day of shot arm hurt for several hours then went away. Day 3 still listless, tired, headache, foggy.
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| 69 | 2021-02-26 | feeling abnormal |
Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours)...
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Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours) Body aches, nausea, fogginess, light headed, tiredness (2 weeks)
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| 69 | 2021-02-27 | feeling abnormal, nervousness |
Within 10 seconds I began to feel that something was wrong. A full body response of a swirling con...
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Within 10 seconds I began to feel that something was wrong. A full body response of a swirling congestion, extreme weakness. very blurry vision and couldn't think straight. I had trouble walking to recovery room, felt nauseous and weak and had a very fast heartrate. I had to stay in private recovery room for 45 min. I was still very ill and nervous at this point. I left with a family member and asked to be driven to the nearby hospital emergency room. For a precaution . We parked across from ER entrance for another 1 hour till I slowly regained strength to 50% normalcy. I went home afterwards and had to go to bed. I was unable to drive my own vehicle home. Day 2, still feel weak, shaky and not normal. I consider this a serious adverse reaction that did not receive medical intervention but will prevent me from getting the second Pfizer shot. After 5 hours post injection I felt 60% normal . Day 2, 70 per cent normal. The vaccination facility was not able to do blood pressure monitoring ( which is a problem for anyone experiencing reactions.) They said their protocol was to call 911/ambulance. My blood pressure was checked by a certified PA with professional equipment at the 3 hour post injection time and the diastolic pressure was still below 50. And heart rate above normal. Still weak and nauseous.
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| 69 | 2021-02-28 | anxiety |
She reported feeling like her throat was closing and was also experiencing lightheadedness, apprehen...
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She reported feeling like her throat was closing and was also experiencing lightheadedness, apprehension, and numbness/tingling in her left hand. Her vital signs were monitored every 5 minutes for 20 minutes, and she was given 20 mL (50 mg) of liquid Diphenhydramine. Her signs and symptoms subsided, and she was ambulatory and stable with no distress at dismissal from clinic.
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| 69 | 2021-02-28 | crying |
muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; pa...
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muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.
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| 69 | 2021-02-28 | hallucination |
temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! se...
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temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! severe Headache neuropathy SEVERE Hands were like frozen
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| 69 | 2021-02-28 | sleep disorder |
Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nau...
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Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nausea, lack of appetite. That evening, awoke out of sleep at 3 am with extreme abdominal pain, walked to bathroom and almost passed out, had to lay on the floor for 15 minutes.. After a half our it happened again. No diarrrhea but had 2 soft formed stools (very unusual for me). A lot of nausea, weakness and abdominal pain. Chills for 2 days.
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| 69 | 2021-03-01 | feeling abnormal |
Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injec...
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Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injection site - 5in long, 3in wide - slept most of day. Symptoms mostly gone by 3/2 7am, with exception of raised area at injection site and mild fuzzy thinking. Took two tylenol for headache 6p
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| 69 | 2021-03-01 | sleep disorder |
1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelin...
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1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement. Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work. Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm. Slept in 2 hrs increments all night. Saturday sipped fluids
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| 69 | 2021-03-04 | anxiety |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extre...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt complained of blurred vision and anxiety 15 min after injection. After another 10 min, pt complained breathing was becoming difficult. She refused oral Benadryl. I called 911. Paramedics gave her IM Bendaryl. Pt refused to go to ER as symptoms had improved. She waited an additional 20 minutes in pharmacy before going home.
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| 69 | 2021-03-05 | feeling abnormal |
It started with a lot of pain in the right arm from the vaccine, a lot of fatigue, a horrible headac...
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It started with a lot of pain in the right arm from the vaccine, a lot of fatigue, a horrible headache that didn't go away with nothing, chills with a high fever. I only had a little water and Coca Cola, with Saltines cookies. I felt disgusted. Today March 6 I am still tired and without appetite. I still have a slight fever. I have taken Advil and switched to Tylenol, but the headache didn't go away with nothing. I feel a little better now 9:20 am 06/03/2021, but still feeling bad.
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| 69 | 2021-03-06 | feeling abnormal |
Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. A...
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Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. At around 3am woke up. Walked to bathroom to urinate. Stood up, started severe nausea and retching. The next thing I remember is finding myself on the ground in the bathroom, retching into the shower area. Called my husband (we are both physicians). My shirt was completely drenched. I was unable to stand up for 5-10 minutes. He noted a 6" hole in the wall (completely through the sheetrock) behind me. I had no memory (and still don't) or falling or hitting my head. He walked me back to bed. My BP was 110/65, pulse was around 70, pulse ox was normal. Continued retching not as severe. Took one Zofran. Eventually fell asleep. In the morning noticed a painful area at the left posterior part of my scalp. There were flakes of sheetrock there. The next day I was tired, felt slightly off balance, otherwise ok. Feeling of vague fuzziness, off-balance continued for a few days, then resolved.
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| 69 | 2021-03-06 | nightmare |
I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I we...
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I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I went to sleep in my clothes. I woke up a few hours later with a pounding headache; the sound of my heartbeat like a snare drum in my ears, nauseated and with a very, very sore arm. Later, throughout the night, I had continuous head pain, nightmares, chills and soreness. I am better today, but still shaky, I took one Naproxen tablet at around 1 am, as well as a melatonin.
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| 69 | 2021-03-06 | sleep disorder |
I received the 2nd dose of the Pfizer vaccine on 3/2/21. My reactions to the vaccine: 1st dose on ...
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I received the 2nd dose of the Pfizer vaccine on 3/2/21. My reactions to the vaccine: 1st dose on 2/9/21: a little sleepy and a bit sore at the site of the injection. Both symptoms were gone within 24 hrs. 2nd dose on 3/2/21: tired and sleepy the next day and a little itchy rash and sore arm at the site of injection that was about one inch in diameter. The sleepiness and tiredness were gone within 24 hrs. The itchy and sore part of my arm at and around the injection site lasted for about 5 days. I put on Benadryl cream and took Tylenol and that helped. I also put on aspercream to take away some of the pain because I'm a side sleeper and it hurt to sleep on that side. Today is Sunday (3/7/21) and there is no more itchiness or pain but I still feel a little hard bump when I rub around the site of the injection. That doesn't bother me because the sore arm and itchiness at the site of the injection are gone.
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| 69 | 2021-03-07 | feeling abnormal |
a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fa...
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a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
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| 69 | 2021-03-07 | excessive sleepiness |
Heà daçhe réally tired stayed in bed and slept most of dà y. Next dà y nót só tired felt some b...
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Heà daçhe réally tired stayed in bed and slept most of dà y. Next dà y nót só tired felt some better bút still had heà dache linger for another 2 dà ys
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| 69 | 2021-03-08 | anxiety |
Patient returned approximately 20-30 minutes post 2nd COVID vaccination with complaints of throat it...
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Patient returned approximately 20-30 minutes post 2nd COVID vaccination with complaints of throat itching and feeling like her throat is closing. Patient and husband waited 15 minutes in office as instructed but while driving home noticed above symptoms and returned to clinic. Patient states that when these symptoms began she used her albuterol inhaler in her car and states symptoms resolved immediately following this. Upon arriving back at clinic patient was noticeably anxious though exibits no evidence of respiratory distress or difficulty breathing. Patient denies any difficulty breathing, current throat/lip/tongue itching or swelling. Treatment in clinic included 50mg IM Benadryl. VS and exam were normal. Patient monitored for 45 minutes and discharged in stable condition with her husband.
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| 69 | 2021-03-08 | nervousness |
patient was in observation and stated that she was ahe started to feel flushed. Notified medics and ...
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patient was in observation and stated that she was ahe started to feel flushed. Notified medics and vital signs were taken blood pressure was elevated at 197/92, pulse 82 an d oxygen saturation 96%. Patient stated that she had " white coat syndrome" and was nervous. Patient refused further evaluation at the hospital and states that she was feelig well after a few minutes.
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| 69 | 2021-03-08 | sleep disorder |
Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt v...
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Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt very thick and heavy. Throbbing. Pulsating, as though I could feel my heartbeat in my arm when I went to bed. Took to Tylenol or sleep would have been impossible. Woke up to a less painful arm and it improved throughout day feeling almost normal by bedtime 24 hours later. Took 2 Tylenol to ensure sleep. Woke up Tuesday morning and arm felt almost 2100% normal. I thought, wow, that wasn't so bad. BUT I WAS WRONG. Tuesday mid morning, I began to feel what I would describe as jittery. Around 11:00 am a wave of nausea washed over me and subsided. I thought maybe I needed to eat as I hadn't yet so I had lunch. After lunch I began to feel nauseous again and like diarrhea was coming. After going to the bathroom, the nausea started building again, and the diarrhea recurred, and the nausea heightened. By mid afternoon I was on the floor hugging the toilet bowl wanting to vomit, waiting to vomit, groaning. It's been years since I've had nausea or vomiting and the whole experience was unexpected from what I read about possible reactions. I wondered if it was food poisoning but my husband and I had eaten the same thing and he was fine. Finally about 3:30-4:00, 48 ours post vaccine, I threw up multiple times, perhaps 5 times. After about 4:30 pm it was over. I was worried that if I ate again I'd be sick so I only drank decaf tea. I felt exhausted from the ordeal but very wired and jittery too. I crawled into bed hoping for sleep. No luck. At 3:00 am I was still watching the clock and shocked that I couldn't sleep. I had to get up at 6:30 in the morning due to some construction at our home. I was legit exhausted Wednesday. I no recurrence of the nausea or diarrhea after the bout on Tuesday afternoon. I ate modestly but normally on Wednesday and slept normally Wednesday night. Nothing more to report, although I read that up to a week later some people experienced a reaction so I wanted to give it a week to see if anything else would happen. Nothing else to report.
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| 69 | 2021-03-09 | disturbance in attention |
Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty c...
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Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty concentrating Large muscle aches, pain in both sides of my neck Left arm red, hot, bruised Feels like the flu after 4 days
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| 69 | 2021-03-09 | feeling abnormal, insomnia |
About 5 hours after vaccination, unusual ?stingy? headache and tiredness, some malaise after nap. Sy...
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About 5 hours after vaccination, unusual ?stingy? headache and tiredness, some malaise after nap. Symptoms lessened, then disappeared during morning of next day. About 30 hours after vaccination, hot flashes (no fever), chills, tired, but jittery with difficulty sleeping, dizzy, head felt ?weird?, - mostly diminished in morning. About 48 hours after vaccination, headache and tiredness returned -still no fever. Very little soreness in arm over the past two days since injection.
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| 69 | 2021-03-09 | poor quality sleep |
her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; ...
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her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported. There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts. She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.
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| 69 | 2021-03-09 | restlessness, feeling abnormal, sleep disorder |
Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Las...
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Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Lasted most of day after injection.
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| 69 | 2021-03-10 | depression |
march 5 sever throbbing headache relieved with a 1000 mg of tylenol. march 6 headache return but na...
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march 5 sever throbbing headache relieved with a 1000 mg of tylenol. march 6 headache return but nagging just enough let yuo know it tis there and feel of blah and depression runny nose, march 7 systems persist . march 8 mild headache and sniffles march 9 a cough still the feel of blah and headache with sniffles
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| 69 | 2021-03-10 | insomnia |
Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea ...
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Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea in ileostomy bag. I did not sleep Monday 3-8 night. Vomiting .stopped the next day. Little appetite. Temp 3/11 was 99.3 slightly high. No adverse event after first dose 2/15/21.
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| 69 | 2021-03-10 | loss of personal independence in daily activities |
02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued throug...
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02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued through 03/06/2021 then became moderate fatigue - continues to present. 02/12/2021 0030 - dry raspy cough - continues to present but lessened in intensity over time. HISTORY 01/2020 01/08/2020 - felt fine at movie theater, while walking to car swallowed & became aware that my throat was suddenly quite sore - difficult to swallow. Within 15min throat so sore could hardly swallow. Had start of dry cough. ON increased dry cough; HA; joint pain; sweats/chills; low grade fever. 01/10/2020 - HA resolved. Sore throat less painful; very uncomfortable dry cough. Extreme fatigue. 01/11-19/2020 - Due to fatigue, unable to be out of bed for more than a few minutes. Hydrating/soup. Couldn't carry on verbal conversation due to dry cough - no SOB if didn't try to talk. 01/20/2020 - Was able to get up & dressed; left house for short time. Felt better, cough less of problem but persisted. Took about 3-4 weeks to feel 100%. AN ASIDE My osteoarthritis pain, in left hip only, began to get much worse after 01/2020 episode. It took a quantum leap forward in pain again after 1st COVID-19 vaccination.
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| 69 | 2021-03-11 | anxiety |
Progress Notes Cosign Needed Expand AllCollapse All 3/12/2021 Patient: ...
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Progress Notes Cosign Needed Expand AllCollapse All 3/12/2021 Patient: DOB: 6/7/1951 Date: 3/12/2021 MRN: Subjective Patient is a 69 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. Past Medical History: Diagnosis Date ? Acquired hypothyroidism 12/7/2017 ? Nextgen PMH Comments TAH - benign fibroids;Endometriosis;I-131 therapy for thyroid nodule ? Thyrotoxicosis without mention of goiter or other cause, without mention of thyrotoxic crisis or storm Hyperthyroidism; NG PMH ? Unspecified essential hypertension Hypertension; NG PMH ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/12/21 1431 BP: (!) 148/72 Pulse: 73 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy and other than removal of double mask for a brief moment Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Bp checked and pt evaluated. Pt doing well. She feels better knowing her bp is okay and not high. She is pleased with care and denies any concerns today. Pt able to ambulate out of the facility w/o assistance.
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| 69 | 2021-03-11 | confusional state, feeling abnormal |
Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressi...
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Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
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| 69 | 2021-03-12 | mental status changes | Altered mental status, moderate dehydration, nausea and vomiting; Addison?s crisis |
| 69 | 2021-03-15 | nervousness |
Chills, shakes, headache, nauseous and full body aches for 6 hrs. Temperature for 3 days started at ...
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Chills, shakes, headache, nauseous and full body aches for 6 hrs. Temperature for 3 days started at 102 for 4 hrs. Then down to 101 - 100 next 24-36 hrs. Next 24 hrs temp. was 99. - 100. Chills, shakes and nauseous came back again 72 hrs later and lasted about 4 hrs. Headache and nauseous lasted a large part of 3 days. Took Tylenol when symptoms first started and stopped after 3 days when symptoms completely stopped.
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| 69 | 2021-03-17 | confusional state | Dizziness, Confusion, Headache 2 days |
| 69 | 2021-03-17 | confusional state |
Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospita...
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Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospital says it could not be caused by the vaccine 2 covid
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| 69 | 2021-03-17 | feeling abnormal |
Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" ...
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Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" symptoms for 48 hours
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| 69 | 2021-03-17 | poor quality sleep |
3/02/21. Very restless sleep followed by 3 days of very achy muscle and joints, strong sensitivity t...
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3/02/21. Very restless sleep followed by 3 days of very achy muscle and joints, strong sensitivity to light, oral sore spots, ( but not open sores ) and a flushed face. There was no fever. I took Tylenol for the aches and stayed restful, napping during the day . By 03/06/21 I felt fine.
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| 69 | 2021-03-18 | excessive sleepiness |
Beside left arm hurt, whole body was aching, headache, sleeping about 36 hours, chill, a little high...
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Beside left arm hurt, whole body was aching, headache, sleeping about 36 hours, chill, a little high fever....
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| 69 | 2021-03-18 | restlessness, insomnia, feeling abnormal |
woke up 2:00 am 3/19 with abdominal cramps; stomach discomfort, vague nausea, intestinal cramps. Had...
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woke up 2:00 am 3/19 with abdominal cramps; stomach discomfort, vague nausea, intestinal cramps. Had 2 bowel movements, soft but not diarrhea, slight sweats. Most of the night had difficulty sleeping, very restless. Upon waking, still very tired, fuzzy feeling, but no more abdominal issues.
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| 69 | 2021-03-19 | feeling abnormal |
After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shakin...
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After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!
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| 69 | 2021-03-19 | excessive sleepiness |
Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lo...
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Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lowered the fever but didn't take it away. Other symptoms included nausea, loss of appetite, muscle aches, pain in both eyes, pain in the lower backside of my head, pain at injection site. Fatigue. Slept all day and through the night. 3/20/2021 8:50 am - as I complete this form I still have side effects even though most symptoms are gone now; Currently, extremely fatigued with a headache that is at the back of my head only. Soreness at injection site. Other symptoms are gone.
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| 69 | 2021-03-20 | depressed mood, feeling abnormal |
I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but fe...
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I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but feeling like I do I can't work; a slight temp 90.2; had choking episodes; feels like her throat is closing up when she is eating; Food get stuck in my throat; sleeping all day; tired; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included food allergies and meds allergies, anxiety, depression and blood pressure (abnormal). Concomitant medications included clonazepam (KLONOPIN) taken for anxiety from 2001, buspirone (BUSPIRONE) taken for anxiety from 2001, bupropion hydrochloride taken for depression from 2001, bupropion hcl taken for depression from 2001, and amlodipine besilate taken for blood pressure abnormal from 08Mar2021. On 05Mar2021 19:00, the patient experienced headache, and nausea. On 06Mar2021 19:00, the patient experienced sleeping all day, and was tired. On Day 2, she still had more side effects which wake her up. On 10Mar2021 19:00, the patient experienced had choking episodes, feels like her throat is closing up when she was eating, and food got stuck in her throat. On an unspecified date, the patient was upset and muscle spasms felt like something crawling in her leg and felt "crap"; she got to work but feeling like can't work. The patient reported that she had been having side effects and she was scared to have the shot because of her side effects and have when her body don't recognize it. She was asking when they go away. She has had a headache and nausea, was tired and sleeping all day. She felt like her throat was closing up when she eats. She had a choking episode and her grand daughter had to hit her on her back. She had choking episodes last night and this morning and she was now eating soft foods. She saw her doctor Monday for a regular appointment and she told him what happened. He wanted her to take the second dose but she was afraid to take it. She was afraid she will have worse side effects. Right now, she had nausea and drinking ginger ale. Her doctor called her which she was upset because he haven't seen her at all. Last time was 2019; and she just told him how she feel and want person to person. Patient reported she was not going to take 2nd dose because she do not want to go through anymore side effects. Everyone said that there were no side effects. That's wrong and she was having side-effects from day 1 on Friday night. There was an ingredient which she has allergies to. She told the nurse all meds allergies and food allergies which they told her that nothing in it will cause any side effects. They were wrong. She felt crap and she got to work but feeling like she can't work. Patient refused to take 2nd dose. Patient stated that she do not want to go through what she was going through now. The patient reported that she had a slight temp 90.2 on an unspecified date. The events required a visit to the physician office. The patient had no prior vaccinations (within 4 weeks). Outcome of events choking episodes, nausea, tired, feels like her throat is closing up when she was eating, Food get stuck in my throat was not recovered; sleeping all day was recovered on 07Mar2021; headache was recovered on 10Mar2021; and outcome of the rest of events was unknown.
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| 69 | 2021-03-21 | memory impairment |
Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER...
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Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER and evaluated and TPA given. Results good following drug administration sent home after two days. Some mental affects still.
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| 69 | 2021-03-22 | incoherent |
seizure like symptoms; she was drooling; Incoherent; was making a bazooka sounding noise; arms and l...
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seizure like symptoms; she was drooling; Incoherent; was making a bazooka sounding noise; arms and legs shot straight out; This is a spontaneous report from a contactable consumer reporting for their sister (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 69-years-old, via an unspecified route of administration, administered in arm right on 24Feb2021 (lot number: EL1269, expiry date not reported) as single dose for covid-19 immunisation. Medical history included stroke from Sep2020 to an unknown date, cognitive impairment from having stroke, chorea movement of the mouth (she is on medication), blood pressure, cholesterol, anxiety, blood thinner, bones, mouth movements and tooth cleaning from an unknown date and unknown if ongoing. Concomitant medications included ongoing amlodipine at 2.5 mg, daily taken for blood pressure abnormal; ongoing rosuvastatin at 20 mg, daily (has been taking for years) taken for blood cholesterol abnormal; ongoing aspirin [acetylsalicylic acid] from Sep2020 at 81 mg, daily (was on a higher dose but was decreased); ongoing sertraline from Oct2020 at 25 mg, daily taken for anxiety; olanzapine from 20Jan2021 at 2.5 mg, unspecified date at 5 mg, 7 mg, and from 17Feb2021 and ongoing at 7.5 mg, daily taken for mouth movements; ongoing alendronate sodium at 70 mg, weekly (has been taking for years) taken for bone disorder; ongoing apixaban (ELIQUIS) from Sep2020 at 5 mg, daily taken for anticoagulant therapy. It was reported that the patient received the first dose of the Covid-19 vaccine on 24Feb2021. Four days later on 28Feb2021, she had seizure like symptoms. It was not a seizure but it looked like it. She is not sure if this is related. The doctors ruled it out. They said it would be immediate. This could be a coincidence. She is on medication for Chorea movement of the mouth. She was taken to the emergency room and she was admitted to the hospital. Her arm did not even hurt. She was incoherent for about an hour. Things seemed to calm when they gave her IV fluids. Her arms and legs were straight out until she went to the emergency room. She made a noise that sounded like a bazooka. It lasted for a little while. The gave her fluids and took her vital signs. Her arms and legs were no longer stuck out. She was calm when they laid her on the table in the emergency room. It was also reported that the patient was drooling. It was reported that they ran all kinds of tests, MRI, EKG, brain wave thing, unable to find any sign of seizure. Her arms and legs shot out and she sounded like an automatic gun, "ah, ah,ah,ah, us". She told them in the hospital, that she had the covid vaccine, and they said no, it was not that because it was to long after the vaccine. The patient was hospitalized for seizure like symptoms from 28Feb2021 to 03Mar2021. The patient underwent lab tests and procedures which included computerised tomogram: normal, electrocardiogram: normal both on 28Feb2021, magnetic resonance imaging: negative on 02Mar2021, scan brain: normal on 01Mar2021. Therapeutic measures were taken as a result of incoherent and was making a bazooka sounding noise which included IV fluids. The patient recovered from seizure like symptoms, was making a bazooka sounding noise, arms and legs shot straight out on 28Feb2021, from incoherent on 01Mar2021, while the outcome of drooling was unknown.
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| 69 | 2021-03-22 | loss of personal independence in daily activities |
Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - be...
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Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - began some time in early morning of March 21 Called Emergency Room. Spoke to ER doctor who recommended: 2 Tylenol, 1/2 Benadryl, plenty of fluids, eating light, light activity level I followed these except used only 1 extra strength Tylenol which I repeated twice during the day. Spent most of day sleeping. Improvement by morning of March 22. March 22 - tiredness continued so limited activity.
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| 69 | 2021-03-23 | disorientation |
Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extre...
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Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extremely tired, all began about 12 hours after injection. Adverse reactions started to subside about 12 hours after onset, and were completely gone after about 36 hours.
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| 69 | 2021-03-24 | excessive sleepiness |
Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day af...
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Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day after the second dose (Tuesday, March 16, 2021), I slept 19 hours, sat up for 1 hour, and went back to bed and slept another 16 hours. Upon waking on the second day after the vaccination (Wednesday, March 17, 2021), the fever had broken and the aches were not as severe but still present. No food or drink were consumed as I slept the entire time. On the third day after the vaccination (Thursday, March 18, 2021), aches were gone, but I was so weak with little energy. In addition, I had lost 3.5 pounds since the day of the vaccination. I could not find a thermometer (as well as was too tired to look), so I cannot tell you what my temperature was, but my face/forehead was hot to the touch.
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| 69 | 2021-03-26 | feeling abnormal |
Pfizer-BioNTech COVID-19 Vaccine EUA I had no symptoms after the first Pfizer vaccine. On Tuesday, ...
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Pfizer-BioNTech COVID-19 Vaccine EUA I had no symptoms after the first Pfizer vaccine. On Tuesday, March 23, 2021 I had the second vaccine and had flu symptoms the next day with body aches and fatigue. I felt better the day after that-Thursday. This morning, Saturday, as soon as I got out of bed, my face burned and turned bright red. I looked like I had a sunburn. My arms, especially around my elbows turned an angry red. They didn't burn as badly as my face. Around an hour later, the redness subsided, but my face still feels hot. I don't feel like myself and am taking it easy today. I want to report this so you are aware of the reaction. I take no medications and am extremely healthy. My last vaccine was in 1976.
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| 69 | 2021-03-27 | feeling abnormal | Chills without fever, total body pain not just aches, mental fogginess, extreme fatigue |
| 69 | 2021-03-27 | loss of personal independence in daily activities, feeling abnormal, sleep disorder |
I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction...
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I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction started. Intense pain and swelling of right side of neck for 3 days. Also left wrist unable to use. Pale, ill. Vital signs ok. Then on 3/8, pain switched to left side of neck and upper back. 3/10, right neck again with swollen lymph nodes bilateral. 3/11 back of neck and upper back hurts. Intense. Could not sleep. 3/12 pain in upper quads and hips, mid pack. Feeling freezing cold. Temp ok. Called my Dr. Right side of neck continued to hurts even now (3/28/2021) but at least I can function now. I no longer feel sick, brain fog, cold. So greatly improved but not normal. Reaction has lasted a month. Vaccine number one resulted in 2 days feeling ill with upper back pain, chills but only a few days. First night vomited, passed out. First vaccine reaction was frightening but was short lived. I am a retired RN.
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| 69 | 2021-03-28 | loss of personal independence in daily activities |
Patient states that she had numbness in both feet and legs. Several days later these symptoms were ...
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Patient states that she had numbness in both feet and legs. Several days later these symptoms were getting worse and she went into a seizure, lost control of her use of her legs, arms and her bladder. She called 911 and transported to y Hospital ER. She had MRI w/ negative results and was given fluids. She was released to go home. Pt has appt w PCP and will discuss her symptoms w/ them. Pt is still weak, has fatigue but can use her arms and legs. She is not able to do normal activities. She had her 2nd Covid dose on 3/26/21 @ 9:20 am in her right arm.
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| 69 | 2021-03-29 | feeling abnormal | Extreme fatigue, muscle aches, pain at site of injection, slight headache and brain fog |
| 69 | 2021-03-30 | insomnia |
last night she couldn't sleep; Itchy Hives/Welts/welts are annoying; on her inner thighs, groin, wai...
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last night she couldn't sleep; Itchy Hives/Welts/welts are annoying; on her inner thighs, groin, waist and arms pits; developed welts and itching; Rash, Hives and welts, and states they are itchy; start with a small regular size and get bigger and elevated on the skin; start with a small regular size and get bigger and elevated on the skin; This is a spontaneous report from a contactable Nurse (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration as single dose 1st dose in left arm on 22Jan2021 (Lot # EL9741), 2nd dose in right arm on 12Feb2021 (Lot # EM9809) for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On 06Feb2021, 2 weeks after receiving her first dose, the patient experienced itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, developed welts and itching, rash, hives and welts, and states they are itchy. Patient also reported she received her 1st Covid dose on 22Jan2021 which is clarified that this is when the hives and welts started (under clarification). On unspecified date the patient experienced start with a small regular size and get bigger and elevated on the skin. On 03Mar2021 she couldn't sleep. The event itchy hives was considered medically significant by reporter. Course of events: Two weeks after receiving her first dose she developed welts and itching that has persisted through today. She has not changed medicines, foods, soaps or detergents. She has been taking Benadryl for about a month now for the itching. She reported rash, hives and welts, and stated they are itchy. They started with a small regular size and get bigger and elevated on the skin. The welts are annoying; on her inner thighs, groin, waist and arms pits. She ruled out foods or any products she had, and she wasn't taking anything new. She was using Benadryl Extra Strength Cream on her hives and after a few minutes it resolved, but last night (03Mar23021) she couldn't sleep, it usually resolved after a few minutes, but this time it lasted over an hour, states she had to just keep slathering it on because it wasn't helping. The outcome of itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, welts and itching, rash, hives and welts, and states they are itchy was not recovered, of start with a small regular size and get bigger and elevated on the skin, last night she couldn't sleep was unknown. A Product Complaint was filed. The reporter assessed the events hives and welts as related to the vaccine.
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| 69 | 2021-03-31 | disorientation |
swelling of the face and tongue. lightheaded. headache. soreness and some disorientated, as well ...
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swelling of the face and tongue. lightheaded. headache. soreness and some disorientated, as well as severe dryness of the mouth.
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| 69 | 2021-03-31 | feeling abnormal |
The day following receiving second vaccine, I woke with a headache. I had eaten little the day befor...
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The day following receiving second vaccine, I woke with a headache. I had eaten little the day before and attributed it to hunger. I went to kitchen to prepare breakfast. Before eating anything, my body felt very strange. I began moaning/screaming for my sister who was upstairs and tried to make my way to my bed. My legs did not seem to go where I wanted them to go. For example, if I wanted my right leg to go right, it went left. i felt like a pinball bouncing off my walls. I made it to the foot of my bed and realized I was going to pass out. I allowed my self to drop to the floor which I thought would be a safer fall. I landed with a thud. I could not get myself up with ut assisstance. I needed the bathroom. I felt like I would vomit. I did not. I did have diarrhea. I spent the rest of the day in bed either shivering or sweating. I ate light, tea, toast, etc. At one point I took temperature . it was 99.6. My bottom was bruised for about 15 days. I had no further complications.
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| 69 | 2021-03-31 | loss of personal independence in daily activities |
Extremely severe overall body pain to the point I could not function at all for 4 days. Almost 2 w...
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Extremely severe overall body pain to the point I could not function at all for 4 days. Almost 2 weeks later almost back to normal
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| 69 | 2021-04-01 | depressed mood |
Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited n...
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Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited non-interventional study report from the marketing program received from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in Jan2021 (Batch/Lot number was not reported) as single dose, second dose intramuscular on 15Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA, Solution for injection in pre-filled syringe), subcutaneous from 2015 (Batch/Lot number was not reported) to 2020, at 40 mg (40 mg,1 IN 2- 2), subcutaneous from 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 IN 2- 2) for Moderate To Severe Rheumatoid Arthritis and lupus. Medical history included hatal hernia, blood clots on legs were not worsened with Humira, non smoker, abstains from alcohol, allergy to latex manifested by rash, allergy to Sulfa drugs manifested by upset stomach. Concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure, start and stop date were not reported; ezetimibe (ZETIA) taken for blood cholesterol, start and stop date were not reported; folic acid (FOLIC ACID) taken for rheumatoid arthritis, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for hiatal hernia, start and stop date were not reported; apixaban (ELIQUIS) taken for blood clots on legs, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; proline (PROLIN) taken for an unspecified indication, start and stop date were not reported; tramadol (TRAMADOL) taken for pain, start and stop date were not reported. The patient experienced lung disorder on an unspecified date with outcome of not recovered, post procedural complication on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of not recovered, tiredness in Jan2021 with outcome of recovered in Jan2021, feeling down on an unspecified date with outcome of unknown. Clinical course: Solicited report by a consumer of a 69 year old female with events of small tumor on thyroid, blood clot on both legs, coughing and shortness of breath and non-serious lungs issue caused by methotrexate, after surgery shaking a bit, tired and cloudy weather caused to feel down a bit with HUMIRA 40MG/0.4ML (ADALIMUMAB). The patient had a relevant medical history of hiatal hernia and blood clots on both legs. On unknown dates, the patient experienced lungs issue caused by methotrexate, after surgery shaking a bit and cloudy weather caused to feel down a bit. In 2016, the patient experienced blood clot on both legs. In Sep2020, the patient experienced small tumor on thyroid. On 01Sep2020, the patient experienced coughing and shortness of breath. In Jan2021, the patient experienced tired. In Jan2021, the tired resolved. Methotrexate and covid-19 vaccine were also considered suspect. In Sep2020, the patient was admitted in hospital for cough, shortness of breath and was treated with unknown oral and intravenous antibiotics. While she was in the hospital, it was discovered that she had a tumor on her thyroid. She had stayed a week in hospital. She also had a lung issue. It was discovered lots of scar tissue on lungs and according to the physician it might be from patient's lupus, rheumatoid arthritis or methotrexate. The physician said that it was caused by the methotrexate not the Humira. Methotrexate was stopped for her. Patient denied to have pulmonary fibrosis and said that according to her doctor she did not have it and she did not know her diagnosis as it was not discussed with her doctors. For problems in lungs, patient was on oxygen. Patient was off of Humira for three weeks. She had surgery on thyroid biopsy. After the surgery she was shaking a bit. She thought it was because of the anesthesia but she was fine shortly after. The biopsy results were inconclusive which looked like it was not cancerous but physician could not really tell patient if it was or it was not. On unknown date in 2020, patient had restarted Humira again. On 04Dec2020, patient had thyroid tumor removed and was on oxygen until 11Jan2021. Sometimes the cloudy weather caused patient to feel down a bit. She did not have any paper work for the blood test. It was unknown if patient was enrolled in a covid-19 vaccine trial. In Jan2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer. On 15Feb2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. The reported events except for coughing were serious as medically significant. The patient underwent lab tests and procedures which included biopsy: inconclusive in Oct2020 and in Dec2020, biopsy of tumor: inconclusive in Sep2020, blood test: unknown results in 2020, computerised tomogram of chest: unknown results in Oct2020, COVID-19 TEST: negative in 2020 and in 2020. The action taken in response to the events for bnt162b2 was not applicable, for methotrexate sodium was permanently withdrawn on an unspecified date, for adalimumab was dose not changed. The reporter's assessment of the causal relationship of the events with the suspect products bnt162b2 and methotrexate sodium was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. Information on Lot/Batch number has been requested.; Sender's Comments: Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of events, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-04-04 | loss of personal independence in daily activities |
extreme fatigue, shortness of breath, lungs feel like they're going to burst. Unable to do simple ...
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extreme fatigue, shortness of breath, lungs feel like they're going to burst. Unable to do simple chores without lungs bursting. Unable to walk daily. Since receiving the 1st vaccine I have been experiencing fatigue and it hasn't gotten any better after receiving the 2nd vaccine. Prior to receiving the Pfizer vaccine, I was very active. I walked 5 miles daily and had an abundance of energy. I'm having a hard time walking 2 miles and my breathing is very labored when I walk. My lungs feel like they're going to burst. I'm out of breath just doing simple chores at home. These symptoms are not getting any better and I'm beginning to get a little nervous. Let me say I was blessed not to have contracted COVID.
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| 69 | 2021-04-05 | excessive sleepiness |
The day following the shot, I was extremely tired in the afternoon, took a 4 hour nap and then went ...
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The day following the shot, I was extremely tired in the afternoon, took a 4 hour nap and then went to bed at the normal time, still tired. Woke up the next morning with no symptoms.
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| 69 | 2021-04-05 | sleep disorder |
General malaise, weakness, urticaria & pruritus mainly on injection arm, but proceeding to other pa...
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General malaise, weakness, urticaria & pruritus mainly on injection arm, but proceeding to other parts of body. The pruritus is awful & wakes me up at night.
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| 69 | 2021-04-06 | feeling abnormal |
Nausea, vomiting, diarrhea, itching, brain fog, speaking in tongs, dizziness. It has been one we...
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Nausea, vomiting, diarrhea, itching, brain fog, speaking in tongs, dizziness. It has been one week since last vaccine and I am still having symptoms.
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| 69 | 2021-04-06 | insomnia |
If she laid her arm on it, it was painful on the left side where she got the injection between her l...
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If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-04-07 | confusional state | difficulty breathing, confusion, Unresponsiveness, pulmonary congestion. |
| 69 | 2021-04-07 | memory impairment, disturbance in attention, feeling abnormal |
Brain fog/felt like there were "holes" in my memory. Couldn't think of my son's middle name. Unawar...
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Brain fog/felt like there were "holes" in my memory. Couldn't think of my son's middle name. Unaware that I ate something. Lasted 2 days. Unrelated to normal "forgetfulness" due to age. Vaccine received in morning, arm increasingly felt stiff and sore until bedtime. Worried it would get worse overnight (felt much better in the morning).
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| 69 | 2021-04-08 | disturbance in attention |
2 days after dose #2: headache, muscle/joint ache, chills, loss appetite,swollen lymph glands, brain...
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2 days after dose #2: headache, muscle/joint ache, chills, loss appetite,swollen lymph glands, brain fade. Every other day for over 2 weeks.
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| 69 | 2021-04-09 | feeling abnormal |
Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg crampin...
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Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; the inside of her thighs were a little red on the side, both legs from her thighs to her knees; the shot is already fogging her mind; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 08:30 (Lot Number: ER8727; Expiration Date: 31Jul2021, at age of 69 years old) at a single dose for covid-19 immunization. Medical history included allergies: Penicillin, Ampicillin, hair color product. The patient's concomitant medications were not reported. She was allergic to Penicillin, and Ampicillin. As a child, always reacted strongly to any vaccination she was given with a fever and flu like symptoms for a couple of days. With Ampicillin, she thought she was having a heart attack. Was told to stop Ampicillin immediately because she could get a heart attack. This was when she was 25 years old and she never went to the ER. She was allergic to a hair color product in the 1990s and it made her scalp itch really badly. Was given a cortisone shot, which she reacted immediately breaking out head to toe in hives. Has no NDC/LOT/EXP for the vaccinations she reacted strongly to as a child. Stated this was in the 1950s or early 1960s. Clarified she did not have a heart attack with Ampicillin, but it felt like she was having one. Has had cardiograms per her request and her heart and heart walls are perfect. The patient received the first dose of the Covid vaccine at 8:30 a.m. this morning on 26Mar2021. Caller reports around 11 a.m., she experienced excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh, states that the pain lasted 15 minutes. The patient reports the same pain occurred on the opposite leg around noon and lasted for 15 minutes, states that "the pain was so excruciating that she could barely stand up and it was so agonizing it was unbelievable." The patient noticed that the inside of her thighs were a little red on the side, both legs from her thighs to her knees. The patient states that she has not been in the sun, and didn't think it was anything alarming, but this is abnormal for her, states that she received the vaccine in the right arm and her upper torso is fine and her head is clear, asked if anyone else had reported this reaction. She was planned to received the second dose on 16thApr in the early afternoon. The patient stated the COVID shot was already fogging her mind. The patient felt pretty good after first shot. Felt nothing. Fifteen minutes before leaving the diner she got a leg cramp. Was sitting in a booth and didn't think much of it. Attributed it to the way she was sitting. Around 11AM when she got back to her garage, she was in agony. It hurt from the top of her rear all the way down the side to the back of her knee and rolled to the inside of her thigh. She was in such agony and didn't know if she could get out of her chair and walk. By the time she reached her apartment it has subsided. An hour later, same thing happened in the left leg. She was laying in bed and texting because she didn't' know if she would get any other reaction. This leg cramp was even worse. She was in tears. Got off bed to try and walk it off. Initial leg cramp happened in right leg. Was excruciating. Both times it lasted for 15 minutes. Both cramps were from her buttocks, all down to her knees, and rolled over into her thigh. Didn't know if that was a reaction. It is not typical of anything written on Pfizer's information or that she had heard. She was concerned. Heard about blood clots, but not with this particular product. Stated second leg cramp subsided. If it hadn't, she wouldn't have gone to the ER. Leg cramps was so excruciating. Originally thought it was coincidental and stated she will be 70 on (Date withheld). To say she has never had leg cramps before would be a lie. The way the leg cramps were timed was kind of weird. It was absolutely the same kind of cramp and location just on the a different leg. Weight: Gained 25lbs. Doesn't have COVID or any symptoms. Tested three to four months ago and was negative. Received first dose COVID-19 Vaccine today, 26Mar2021, at 08:30AM. First leg cramp began 11:00AM in right leg. Second leg cramp began Noon in left leg. Each time lasted 15 minutes. Not having leg cramps right now. Could barely talk when having leg cramps. Was worried about getting clots in legs. Otherwise she would think it was because she was getting older. She doesn't get leg cramps very often. Doesn't know when the last time she had leg cramps prior to today. Nurse technician at vaccine faculty stated caller's allergy history wouldn't be a problem and she only had to sit for 15 minutes. Received the COVID-19 Vaccine and hardly felt it. Waited for 15 minutes. She was fine until 11AM. She was fine now, but her arm might get a little stiff tomorrow. Arm was slightly tender. Surprised she felt something in her legs. Doesn't know whether to associate it with COVID-19 Vaccine or not. Has nothing to complain about in the upper torso or from the waist up. Wants to know if this is a reaction or coincidence. Stated she expected to have a stiff arm. The outcome of the event "Cramps in legs" and "pain" was recovered on 26Mar2021. The outcome of other events was unknown.
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| 69 | 2021-04-09 | memory impairment, anxiety, feeling abnormal, insomnia, disturbance in attention |
Day 0: hot left arm, blood to surface of skin on inner arm, two inches below injection site, size of...
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Day 0: hot left arm, blood to surface of skin on inner arm, two inches below injection site, size of dime (resolved Day 3); Day 0: Pain at injection site (resolved Day 3); Diarrhea (resolved Day 3); Fatigue (resolved Day 12); Dizzy (resolved 90% by Day 29). Day 1: Insomnia (resolved Day 17), nerve pain on left eye, ear, leg, and foot, and headache (resolved Day 6); Tinnitus (not resolved); hypervigilance, feel like I am speeding, high anxiety during normal routines (resolved Day 17) Day 8: Brain fog, unable to concentrate, immediate memory impaired, feel like I am getting dimentia (like covd patients say (resolved 80% by day 29)
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| 69 | 2021-04-11 | confusional state, abnormal behaviour, loss of personal independence in daily activities, memory impairment, disturbance in attention |
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like sy...
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Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
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| 69 | 2021-04-14 | sleep disorder |
Minor headache late evening on vaccination day the 24th around 2:00 pm. Next morning minor headache ...
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Minor headache late evening on vaccination day the 24th around 2:00 pm. Next morning minor headache generally not feeling well, around noon headache became intense and pressure in my chest, so not comfortable lying down, sat up and walked around much of the night. Finally took ibuprofen which didn't help. Next day I was a bit tired but done with the headache and feeling of illness. Worst lasted about 12-15 hours.
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| 69 | 2021-04-19 | loss of personal independence in daily activities |
Second vaccination on 3/30. At 11 pm developed qualitative fever (unable to quantify), lasted 24 hrs...
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Second vaccination on 3/30. At 11 pm developed qualitative fever (unable to quantify), lasted 24 hrs. On 4/3/21 woke up in AM with hives covering trunk. This has persisted and caused significant discomfort and impacted ability to do daily activities. Associated fatigue.
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| 69 | 2021-04-21 | feeling abnormal |
pt says the next day after getting the vax she was completely fatigued. She had to lay flat on her ...
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pt says the next day after getting the vax she was completely fatigued. She had to lay flat on her back from 3/26/21 to 4/3/2021. She had a sore in her mouth She had her second chemo infusion on 4/7/21 and started her chemo pills again. On 4/9/21 she was completely fatigued. She feels like she had just taken the vax again. She has a strange taste in her mouth, like a coating in her mouth. She has nausea, loss of appetite, very weak and has SOB. she had to cancel her appt for her 2nd covid vax dose. She has another infusion coming up on 4/27/21 so she is really concerned about getting another dose with the side affects she is having. She is very frail feeling and scared since she did well after taking the chemo infusion until getting the covid vax. Now she says she feels disabled and cant do anything anymore. She called her oncologist clinic coordinator to let them know her symptoms.
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| 69 | 2021-04-24 | anxiety, feeling abnormal |
tightness under the right breast area/it was mild spasming/spasm feeling under right breast area; fe...
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tightness under the right breast area/it was mild spasming/spasm feeling under right breast area; felt wobbly; dizzy/lightheaded; anxious; feeling funny; acid reflux/had a flare up of gastrointestinal system; acid reflux/had a flare up of gastrointestinal system; wave go across her stomach/had a feeling like a wave across her stomach, like a shiver; night sweats; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration, in the right arm on 27Feb2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, breast cancer female diagnosed in 2001 (She had two other bouts. One was in 2009 and one was in 2015. She doesn't have breast cancer now), mastectomy on an unknown date, thyroid issues from an unknown date and unknown if ongoing (Her thyroid was burned out when she had radiation), and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol for hypertension from an unspecified start date and ongoing(been on it for years); amlodipine besilate (NORVASC) for hypertension from an unspecified start date and ongoing (been on it for years); levothyroxine sodium (SYNTHROID) for thyroid disorder from 2002 and ongoing; atorvastatin (LIPITOR) for blood cholesterol increased from an unspecified start date and ongoing. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. No additional vaccine(s) was administered on same date as BNT162B2. She has a history of acid reflux and "gastrointestinal whatever". On 27Feb2021, when she was sitting there for 15 minutes after the vaccine, she had a feeling like a wave across her stomach, like a shiver. The next morning, on 28Feb2021, when she got up she felt like she was in menopause again because she had night sweats. She is 69, about to be 70 years old. She felt wobbly and walked around for 4 hours. She felt tightness under the right breast area. It was a mild spasming. She was feeling funny, lightheaded, dizzy, and anxious. On 28Feb2021, the day after the vaccine she had an episode, or recurrence, with acid reflux and went to the emergency room for a wellness check to make sure it wasn't heart related. Everything with her heart checked out and they said it was gas. They gave her simethicone (GAS-X) and she was sent home. At the emergency room they also found that her red cell count was on the borderline range and that her body may have already been fighting the vaccine already. She was eating small meals and having problems. She went to her doctor because the gastrointestinal issues had continued who said she had a flare up of gastrointestinal system. Her doctor said to take omeprazole 20mg capsule once a day and take famotidine (PEPCID) 10 mg (Expiry: Oct2023/Lot number: SPF043) before bedtime. Her doctor gave her a diet and said to not eat after 7. She saw the doctor on 05Mar2021 and started omeprazole and famotidine that day. The patient stated she is responding okay but still having occasional spasms. This maybe only occurs once a day. Her symptoms are manageable but she has a spasm feeling under right breast area. She said it may be from her anxiety. It has been over 2 weeks and she is due for the second shot. She is looking for information that Pfizer has about this side effects and the second shot. What could she do to ward off anything? Should she take the second shot? People say the second is worse than the first and she is not fully recovered and due for the second one. The outcome of the events, acid reflux/had a flare up of gastrointestinal system, wave go across her stomach/had a feeling like a wave across her stomach, like a shiver, night sweats, tightness under the right breast area/it was mild spasming/spasm feeling under right breast area, felt wobbly, dizzy/lightheaded, anxious, and feeling funny was unknown. Follow-up attempts are completed. No further information is expected.
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| 69 | 2021-04-26 | amnesia, memory impairment |
TRANSIENT GLOBAL AMNESIA HOSPITALIZED. RAN CT AND MRI SCANS - NOT ABLE TO FIND CAUSE. CAUSE UNKNOWN...
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TRANSIENT GLOBAL AMNESIA HOSPITALIZED. RAN CT AND MRI SCANS - NOT ABLE TO FIND CAUSE. CAUSE UNKNOWN. NO TREATMENT.
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| 69 | 2021-04-26 | amnesia |
moderate memory loss after 2nd injection; This is a spontaneous report from a contactable consumer (...
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moderate memory loss after 2nd injection; This is a spontaneous report from a contactable consumer (patient). The 69-year-old non-pregnant female patient received second dose of PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided), via an unspecified route of administration, in the left arm, on 17Feb2021 (at the age of 69-year-old) as a single dose for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. Patient's medical history and concomitan medications were not reported. Patient previously received first dose of covid vaccine on 27/01/2021 and experienced mild, short-term memory loss. Patient did not have covid prior vaccination. Patient was not tested covid post vaccination. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. On 27Jan2021 at 10:30, patient experienced moderate memory loss after 2nd injection. Patient visited emergency room due to event. As reported, treatment received was unknown. The outcome of event was not resolved. Information of lot/batch number has been requested.
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| 69 | 2021-04-26 | feeling abnormal |
fatigue; nausea; brain fog; body weakness; This is a spontaneous report from a contactable consumer....
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fatigue; nausea; brain fog; body weakness; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6199) via an unspecified route of administration on 04Mar2021 at 14:45 (at the age of 69-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included chronic fatigue, depression, sleep disorder, anxiety, possibly other chronic and acute disease, and allergic to wheat or wheat product. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included sleep medications, antidepressants, cetirizine (ZYRTEC), acyclovir, ibuprofen, and "multivitamins - B, C, E, biotin, psyllium, selenium, alpha lipolic acid, folate, magnesium (Mg), potassium (K)." On 04Mar2021 at 18:00, within 3 or 4 hours the patient experienced fatigue, brain fog, nausea, and body weakness. The patient was not hospitalized for the events. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. The patient was treated with calcium carbonate (TUMS) for nausea. The outcomes of fatigue, brain fog, nausea, and body weakness were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 69 | 2021-04-26 | excessive sleepiness | Previously noted, but took and take lots of Tylenol, Voltarin and muscle relaxers to sleep |
| 69 | 2021-04-26 | impaired work ability |
(Pfizer shot #2)? serious flu like symptoms including full body aches requiring pain pills for relie...
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(Pfizer shot #2)? serious flu like symptoms including full body aches requiring pain pills for relief, chills, severe headache, and sudden onset of lightheadedness accompanied by nausea . Felt like I was going to pass out and throw up simultaneously. Symptoms persisted for approximately 36 hours requiring me to miss work for two days.
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| 69 | 2021-04-26 | insomnia |
shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a ...
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shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
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| 69 | 2021-04-27 | amnesia |
mild, short-term memory loss after 1st injection; This is a spontaneous report from a contactable co...
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mild, short-term memory loss after 1st injection; This is a spontaneous report from a contactable consumer. A 69-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID vaccine. On 27Jan2021 10:30 the patient experienced mild, short-term memory loss after 1st injection (amnesia). The patient received other vaccination administered in Arm Left on 17Feb2021 as SINGLE DOSE for covid-19 immunization. The adverse event resulted in Emergency room/department or urgent care. The patient receive any treatment for adverse event: Unknown. The outcome of the event was not recovered.
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| 69 | 2021-04-27 | anxiety |
4/28/2021 Mswas observed post Covid-19 immunization for 15 minutes . During the observation perio...
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4/28/2021 Mswas observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 1207. Alert and oriented and Anxious. Actions taken: . Vitals sign taken VAERS form completed Apple juice given VS at 1207- BP- 146/74, P- 60, O2- 100 %, 1222- recheck VS, BP- 154/71, P- 61, O2- 100 % Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/28/2021 11:46 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8736 NDC: 59267-1000-2
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| 69 | 2021-04-27 | fear |
I wasn't sure if I should report this or not. I mentioned I get intermittent muscle spasms in my leg...
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I wasn't sure if I should report this or not. I mentioned I get intermittent muscle spasms in my leg that aren't even bad enough to complain to my doctor or anything. The night of the first injection I was in bed and a spasm started. I started to get up and it was horrible- it went thru my ***entire*** left leg - the front and the back and the top and the bottom - the entire leg. I never had anything like that before and since. And it hurt badly. I considered asking my husband to call someone but I went into the bathroom - actually dragging that leg for the most part - and tried putting heat on via my hairdryer. It actually made it worse which is the opposite of what should happen when I usually get anything like that. Then I tried putting on this salve we use for such things made from Arnica called ArnicareCream. It actually helped the spasms completely and I had to keep it bent while the salve worked itself in - then I could at least walk it off the rest of the way and went back to bed with no issues. I didn't report it to my doctor or anything because I thought maybe it had nothing to do with the shot. Plus no one else was reporting anything like that - it wasn't in the list of possible side effects. But it scared me a lot. I'm only reporting it now because a woman not all that far from us was paralyzed by the shot about 10 hrs later I think (not the same day and date) and it sounded somewhat similar in a weird way. It's like the shot "knows" what the bad parts of your body are and hones right in on it. I did not expect to have any issues either. But it seemed much to coincidental that this happened so far only once in my life and on the night of the first shot. Another minor issue was that my left harm hurt when she jabbed it (second shot did not) and I experienced no pain at all in the arm until a few weeks after the **second** shot which I didn't report. It still intermittently hurts but it feels like it's more related to when I overcarry items, etc. So again, that might not be anything. Plus I'm at the age where I have rudiments of arthritis most likely. But the first item was really way out of league with anything I've ever had.
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| 69 | 2021-04-27 | feeling abnormal |
she received her 2nd covid vaccine 4/1/21 and started to develop symptoms after that. She stated tha...
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she received her 2nd covid vaccine 4/1/21 and started to develop symptoms after that. She stated that she felt light headed. She denies loss of consciousness or head trauma. She states that she just felt very out of it and her brain is fuzzy.
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| 69 | 2021-04-27 | hallucination, nightmare |
Hallucination at 6:20 to 6:25 AM. Nightmares, excessive sleepiness for four days, foul taste. Also...
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Hallucination at 6:20 to 6:25 AM. Nightmares, excessive sleepiness for four days, foul taste. Also my husband was vaccinated at the same time and woke up at approximately 4:00 AM with hives and swelling on his face and inside his mouth causing him to bleed through his mouth. Lasted two days. He?s age 64.
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| 69 | 2021-04-27 | mental impairment |
prior to onset of event she did not have any rheumatoid arthritis problems in her knees; additional ...
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prior to onset of event she did not have any rheumatoid arthritis problems in her knees; additional swelling in her knees; feels like she is gaining weight; can't get her brain to work; more swelling on her waist and back/Additional swelling around her waist/ looks like she has lumps; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 69-years-old), administered in Arm Left on 08Apr2021 14:30 (Lot Number: EW0151; Expiration Date: 11Apr2021) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 2020 and ongoing (fought with it all last year in 2020; but was not diagnosed with rheumatoid arthritis until Feb2021), ongoing chronic obstructive pulmonary disease (probably really got with it about 2012), Breast cancer survivor from 2006 to 2006, and bone density. Concomitant medications included cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication from 16Mar2021 to an unspecified stop date; cortisone (CORTISONE) taken for an unspecified indication from 01Feb2021 to 01Feb2021; methotrexate (METHOTREXATE) taken for rheumatoid arthritis from 06Feb2021 to an unspecified stop date; denosumab (PROLIA) taken for bone density abnormal from 16Mar2021 to an unspecified stop date. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 69-years-old), administered in Arm Left on 12Mar2021 about 16:00-16:30 (Lot Number: EN6204) as single dose for COVID-19 immunization and experienced additional swelling in her knees and rheumatoid arthritis. The patient had preexisting condition of Rheumatoid arthritis prior to any Pfizer-BioNTech COVID-19 Vaccine. Prior to onset of this event, with her rheumatoid arthritis, she did not have any rheumatoid arthritis problems in her knees. With the rheumatoid arthritis it has always been in her hands and arms. She was taking Methotrexate for Rheumatoid arthritis. Rheumatologist told her that additional swelling in her knees event was rheumatoid arthritis. After second dose of Pfizer-BioNTech COVID-19 Vaccine she reported additional swelling around her waist. She had second dose of Pfizer-BioNTech COVID-19 Vaccine shot on 08Apr2021. On 11Apr2021 she noticed additional swelling around her waist. She asked if these swelling events are a side effect of the Pfizer-BioNTech COVID-19 Vaccine, or in combination with her rheumatoid arthritis. Onset time was about 05:30-06:00 after she took a shower, pretty much the same thing as with the first dose: additional swelling in her knees. She noticed swelling around the waist, going towards the back which didn't look right on 11Apr2021. There's no pain at all, it just looks like she has lumps. She has had no other effects from the Pfizer-BioNTech COVID-19 Vaccine other than feels like she is gaining weight. Patient reported no other relevant concomitant products or other medical conditions. She mentioned regarding Methotrexate that they tell her this is a high-quality drug that knocks the immune system down. While providing dates of concomitant product doses caller mentioned she can't get her brain to work on an unspecified date. The outcome of the events "prior to onset of event she did not have any rheumatoid arthritis problems in her knees" and "more swelling on her waist and back/Additional swelling around her waist/ looks like she has lumps" was not recovered while for the rest of the events was unknown. The event "prior to onset of event she did not have any rheumatoid arthritis problems in her knees" was considered as serious (medically significant). No follow-up attempts are completed; information about batch/lot cannot be obtained.
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| 69 | 2021-04-27 | sleep disorder |
affected area was right knee which was replaced last September. Swelling, pain, both of which were m...
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affected area was right knee which was replaced last September. Swelling, pain, both of which were more severe than after the 1st shot. The pain has remained and has not decreased to the point of waking me up during the night. The swelling has decreased. I am seeing the orthopedic surgeon for regularly scheduoed checkup on the knee, but I will ask him about the effects
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| 69 | 2021-04-28 | feeling abnormal, insomnia |
it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal se...
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it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal self; Site pain; Chest pressure; Difficulty sleeping because of heart rate; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP7534), via an unspecified route of administration administered in right arm on 29Mar2021 at 09:20 (at the age of 69-year-old) at hospital facility as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within four weeks. The patient had no relevant medical history. Patient reported that she has people in the family that have had heart problems. Concomitant medication included unspecified vitamins. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EM9990 or EM9890) administered in the right arm on 08Mar2021 (at the age of 69-year-old) for COVID-19 immunisation and had a little fast heart rate but not constant, little fatigue and site pain. The patient previously took steroid injections 2 years ago (2019) and had heart palpitations before. The patient further mentioned that normally after the steroids wear off, the heart palpitations go away. The patient reported that she did not have any problems following the first dose of the COVID-19 vaccine. Caller reported that she had a little fatigue and site pain for just a couple of days but that everything was fine. Patient reported that she felt a little heart palpitations for maybe a day or two and then it was gone following the first dose of the COVID-19 vaccine. After she got the second dose of the COVID-19 vaccine on 29Mar2021, she noticed the heart palpitations again and a little shortness of breath. The heart palpitations and shortness of breath were nothing that she felt that she had to run to the emergency room or anything over. The patient reported that now it was getting difficult for her to sleep sometimes at night because of the heart rate. The patient also reported that she was trying to figure out that from this length of time between her second dose of the COVID-19 vaccine on 29Mar2021 and time of call on 14Apr2021, could the heart palpitations be a side effect from the COVID-19 vaccine. Patient also mentioned that when she experienced heart palpitations before, a whole work up was ordered and she was referred to cardiology and that nothing was found during the work up after previous experience with heart palpitations. The patient also mentioned that she has been fine, that she has been able to work and walk and that she gets her 10,000 steps every day. After getting the COVID-19 vaccine, she was tired and didn't feel like her normal self. The patient also reported that when the time had arrived to get the second dose of the COVID-19 vaccine, about a week before, she may have had a little fast heart rate but not constant. It was also reported that following her second dose of the COVID-19 vaccine on 29Mar2021, the fatigue started about the same time as it did following the first dose, on the second day post-vaccine on 30Mar2021. Patient reported that she was kind of tired and just taking a nap during the day. The fatigue was still ongoing. It was also reported that patient was starting to feel better other than the heart palpitations. The patient reported that yesterday, 13Apr2021, she felt great and could do her normal routine, other than feeling chest pains and palpitations. The heart palpitations are not constant, but are more regular during the day than she was used to. The heart palpitations were really bad last night, 13Apr2021, and that she had difficulty sleeping because of heart rate (couldn't hardly sleep at all). The patient's doctor was scheduling her for an echocardiogram. The patient's doctor did an electrocardiogram (EKG) on her on 08Apr2021 and there was nothing there (normal). The patient's doctor was scheduling her for a stress echocardiogram. The patient also mentioned that after returning from the physician's office, her husband went back and looked at the symptoms from the COVID-19 vaccine information sheet. The patient reported that her husband thought that she needed to call to eliminate everything, that they are trying to figure out why the patient was experiencing the heart palpitations. The patient also mentioned that 2 days ago she got on her treadmill to walk and went for 30 minutes. Patient reported that it normally takes her 5 minutes to recuperate, but that time it took her 20 minutes before she felt comfortable after her walk. The patient also reported that the site pain was nothing serious following both doses of the COVID-19 vaccine. The site pain began shortly after receiving the vaccine and went away after the second day following both vaccines. The shortness of breath probably started about 5 days after she got the second dose of the COVID-19 vaccine. The shortness of breath wasn't enough that she felt that she needed to run to the emergency room. It just felt like when she would breathe, especially at night as she normally breathes with her mouth closed at night, the patient felt like she had to open her mouth to breathe because she can still feel the pressure in chest. The patient was still experiencing the heart palpitations. The heart palpitations are a little worse because they happen so often. Patient reported that initially, she would have a few heart palpitations and then go for hours with none. Patient reported that now, she was feeling the heart palpitations quite a bit. Patient reported that it feels kind of like a little pressure in her chest and then it'll feel like little flutters. The patient further reported that she experiences a little pressure in her chest when she experiences the heart palpitations. At times, the chest pressure would go away, but she always feels the chest pressure there now. The chest pressure has gotten worse over the past couple of weeks and that she was thinking that it would go away like the first one did. Patient reported that she went to the doctor last week and was given an EKG. Patient reported that the EKG was fine and that her physician was scheduling other tests to make sure it's nothing with her heart. The patient didn't think that the heart palpitations and shortness of breath were from the COVID-19 vaccine, but that her husband looked at the vaccine information paper after her doctor's appointment and said she should call Pfizer. The patient had not yet recovered from heart palpitations, shortness of breath, fatigue, and chest pressure while outcome of the rest of the events was unknown.
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| 69 | 2021-04-29 | sleep disorder |
She got her vaccine, she was okay. The next morning her arm was a little bit painful but nothing. ...
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She got her vaccine, she was okay. The next morning her arm was a little bit painful but nothing. Then she woke up and it was terrible, she had a headache, chills with constant shaking, no temperature. She cannot sleep due to the chills after having a couple of blankets due to the shaking. She has arm pain and leg pain and very dizzy and worried about falling. She is also tired. She has been taking Tylenol which has not helped her much. Her liver started aching and she stopped taking it. She has not called her doctor yet.
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| 69 | 2021-04-30 | insomnia |
Arm still hurts; that could be part of this problem propylene glycol; Diarrhea/I havent been able to...
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Arm still hurts; that could be part of this problem propylene glycol; Diarrhea/I havent been able to keep any food in my system; really bad aching; Extreme lethargy; headache; cant sleep; rash; sick from the vaccine; fever; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 and its ingredient propylene glycol (as reported) dose 2 via an unspecified route of administration, in upper left arm on 25Mar2021 (Lot Number: ET8733) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, high blood sugar, high cholesterol from an unknown date. Concomitant medication(s) included rosuvastatin calcium (CRESTOR); levothyroxine sodium (THYROXINE); olmesartan (OLMESARTAN) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccination included dose 1 of bnt162b2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 09:15 (Lot Number: EN6206) as SINGLE DOSE for covid-19 immunisation, and experienced feeling achy and tired, headache, bad diarrhea, fever, could not sleep, sick. The patient preciously received codeine and experienced allergy. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had been really sick from the vaccine. She took it (first dose) on the 5th and felt fine on the 5th but on 6th she started feeling achy and tired with a headache, the day after that she started getting very bad diarrhea and she started running a fever and that lasted about 10 days. On the 25th she went back for second dose and she felt fine on the 25th but on the 26th up until last Wednesday (31Mar2021) she ran a fever a low fever of 115degrees, terrible diarrhea, really bad aching, extreme lethargy, headache, could not sleep, couldn't sleep on the other one either but now she really could not sleep and she got a rash running from her ear across her face down her neck and her arm still hurts and today is April 8th. She has not been able to keep any food in her system like she said last Wednesday (31Mar2021) when the fever finally quit and now she stop having the diarrhea and she had to take Pepto Bismol (treatment) and even that just helped very much. She does not know she think that a more complete sheet should be given of what the ingredients were and what the possible reactions would be because on the initial sheet that all put out, it does not list like glycol she forget it. She wanted a more complete information about all the ingredient because she knew there is one in there that could be part of this problem propylene glycol and on the first sheet it does not list propylene glycol. The outcome of the events sick from the vaccine, that could be part of this problem propylene glycol was unknown, of the event arm still hurts was not recovered, of the other events was recovered with sequelae, the event fever was recovered with sequelae on 31Mar2021. No follow-up attempts are needed. No further information is expected.
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| 69 | 2021-04-30 | loss of personal independence in daily activities |
Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn'...
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Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn't' stand up; Her arm was so sore/arm hurt a bit; Bone in body hurt and everyplace she has arthritis was worse; Bone in body hurt and everyplace she has arthritis was worse; Carpal tunnel reacted adversely; A prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via unspecified route of administration at arm left on 02Feb2021 08:00 AM at single dose for COVID-19 immunization. The patient's medical history included arthritis and she has had surgeries. Concomitant medication was not reported. The patient received her 1st dose of the Pfizer Covid vaccine on 02Feb2021 and said she was fine up until the night of the same day wherein she woke up from her sound sleep feeling absolutely in pain. Mentioned that the parts of her body where she had arthritis and her carpal tunnel acted up which she has never experienced before and said that she normally did not have problems like this. She also cannot get out of bed and said that her husband had to her help her out and she also had a rash. Currently, she was still experiencing tenderness on the injection site and some aches and pains on her body but not as bad as it previously was. The patient had bone in body hurt and everyplace she has arthritis was worse. The patient had the injection on 02Feb2021 at 8AM, and did ok with it, her arm hurt a bit, not bad, and that night she went to bed, and it was every bone in her body hurt and everyplace she has arthritis was worse, and her carpal tunnel reacted adversely, her arm was so sore, she can't believe it, now she has developed a rash. Her arm hurt that night, is a little tender now, it was not real red, just tender. Her husband had to help her out of bed, she could not stand up, she was not a baby, she has had surgeries, she responds well to that kind of thing, so this was unusual. Yesterday she was in bed all day, she did not get out of bed until 5PM. This all came on all of a sudden, she woke out of a sound sleep, she was totally terribly miserable. States her rash through lasted through yesterday, now she has developed a rash, a prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting, but she is sure it will fade, she has had reactions to things before. No further details provided. She has not had any other tests or anything lately. No injections, none of that. Would like to know if she has to get her 2nd dose or not. The outcome of the events her arm was so sore/arm hurt a bit, bone in body hurt and everyplace she has arthritis was worse, Carpal tunnel reacted adversely was recovering/resolving. The outcome of the events rash, pain and cannot get out of bed/she could not stand up was unknown. The outcome of the events tenderness on the injection site was not recovered/not resolved.
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| 69 | 2021-05-12 | anxiety |
SOB, ears clogged and sweaty. Customer c/o sob, clammy skin. Customer also c/ that her ears felt p...
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SOB, ears clogged and sweaty. Customer c/o sob, clammy skin. Customer also c/ that her ears felt plugged for a second. EMS and Nurse onsite responded.. B/P 160/80, HR 66. On 96 cust stated she was fine, just had some anxiety. 1st dose.
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| 69 | 2021-05-17 | feeling abnormal |
second dose is schedule outside of the 21 days; she has been waiting for so long that she is just in...
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second dose is schedule outside of the 21 days; she has been waiting for so long that she is just in a brain fog dead; This is a spontaneous report from a contactable consumer. A 69-Yerars-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021, the patient received first dose of bnt162b2 (Batch/Lot number: EL9623). She had adverse event, like joint pain and headache with first dose. Her chills have went away, but was still getting a little bit of a headache. She had some pain in her arm, but it was much better now. She had waited for over an hour and a half. She was schedule for the second dose tomorrow. She had been waiting for so long that she was just in a brain fog dead, she at first stating that she was on Valacyclovir 1mg but then corrects herself stating that she was taking Valacyclovir 500mg once in the morning and once in the evening, she asks will that interfere with the covid vaccine. She also states that her second dose was schedule outside of the 21 days. The events assessed as non-serious with outcome of unknown. Follow up (29Jan2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported that: vaccine questions answered received. Information about lot/batch number has been requested. Follow-up (21Feb2021): The initial case was missing the following minimum criteria: of a true adverse event, upon receipt of follow-up information on 21Feb2021, this case now contains all required information to be considered valid. Follow-up (22Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reporter for herself that: Patient details (age), events, clinical information were added. No follow-up attempts are possible, information about lot/batch number cannot been obtained.
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| 69 | 2021-05-18 | disorientation, mental status changes |
Exhaustion, joint pain, fever, disorientation, diabetes and blood pressure uncontrolled. She visited...
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Exhaustion, joint pain, fever, disorientation, diabetes and blood pressure uncontrolled. She visited an emergency room at another institution and was hospitalized. A week later she visited our emergency room and was also hospitalized with hypercalcemia dx, altered mental status.
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| 69 | 2021-05-19 | abnormal behaviour, anxiety, panic attack |
right breast has been diagnosed with cellulitis; her right arm which is where the second injection s...
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right breast has been diagnosed with cellulitis; her right arm which is where the second injection site was, not just the site but her whole right arm swelled; Her voice was still weird; they think she has lymphoma; He thought it caused a severe case of laryngitis; She is all upset and hyper; He thinks it's stress; wheezing and sounded horrible; Mid left pillar idiopathy and subcarinal area neoplastic disease; mediastinal mass effect; they thought she was having a stroke; She lost her voice all of a sudden. She couldn't talk; seemed completely out of it; swollen lymph nodes/enlarged lymph node in her right lung/swollen lymph nodes on her right breast; mass in her throat; panic attack; experiencing some difficulty breathing; anxiety; This is a spontaneous report from contactable consumers (one is the patient's husband) received via medical information team and from a Pfizer-sponsored program. A 69-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7533, expiration date not reported), via an unspecified route of administration on 11Apr2021 12:00 (at the age of 69-years-old) at 2nd dose, single in the right arm for COVID-19 immunisation. Medical history included ongoing Hashimoto's disease from an unspecified date (had it for years), basal cell cancer, and the patient's immune system was compromised. It was reported that the patient's father had lymphoma and passed away due to kidney cancer. The patient's mother died at the age of 97-years-old, and was healthy. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing for Hashimoto's thyroiditis. Historical vaccine included first dose of BNT162B2 (lot number: ER8727) received on 21Mar2021 15:00 in the left arm for COVID-19 immunisation. It was reported that the patient experienced swelling on left arm where the injection was and little bit of swelling in the lymph nodes in armpit. The patient's height was 163cm, and weight was 68.01kg; both on unspecified dates. He patient's husband reported that something was happening with his wife (patient), and he cannot find the patient's symptoms on the website. It was reported that the patient had the second shot of Pfizer vaccine 3 weeks ago, this past Sunday. The second shot was given in the patient's right arm, and the first shot was given in the left arm. Everything was normal for close to three weeks. Then on Sunday, on 24Apr2021, the patient lost her voice all of a sudden. She couldn't talk, seemed to be completely out of it, and the patient's husband thought that she was having a stroke. They went to the ER (emergency room). The doctor though that the problem was that the scented detergent the patient used for her mask. The doctor thought that it caused a severe case of laryngitis. The patient was sent home. The patient's voice was still weird last week. It was also reported that the patient's right arm, and breast were swelling. On 2021, the patient experienced some difficulty breathing and anxiety. Two days ago, on 02May2021, the patient noticed that her right breast on the same side as the second shot was enlarged, heavy, and firm. The patient has no history of breast cancer. A couple of days prior (in 2021), the patient's arm was swollen. It was her whole arm. The patient was scheduled to see her dermatologist at 11:30 this morning since she was having a basal cell cancer removed from her face. The patient was all upset and hyper and was having trouble breathing a little bit. The patient's husband thought that it was stress. The patient was scheduled for surgery on her face on Wednesday this week and the patient had a panic attack on an unspecified date in 2021 so the patient was brought to the emergency room. The patient's husband stated that this was because the patient was scheduled for a surgery for basal cell cancer removal, and that the patient's breast being so large, the patient was worried. The patient had Hashimoto's disease for years, and her immune system was compromised. The extra swelling could be because her immune system was working overtime. The patient's voice was good for a while, but today, she was losing it again. The patient uses different laundry detergent now. The patient's husband stated that these never happened before, and that it could be coincidental. The patient had no reactions prior to the 3-week period after the shot. The patient was wheezing now, and the patient's husband may need to call an ambulance. The patient's husband further stated that he took the patient to the hospital (emergency room) this morning because the patient was wheezing and sounded horrible. The hospital record stated that the patient had an enlarged lymph node in her right lung and that her right breast was swollen and infected. The patient was currently in the emergency room and was not admitted to the hospital. The patient was going to have a biopsy today. After the patient's first dose, she had a little swelling on her left arm where the injection was and a little bit of swelling in the lymph nodes in her armpit. The patient's husband noticed that the patient's right arm where the second injection site was, not just the site but her whole right arm swelled, from shoulder to wrist. The patient's husband also noticed that the patient's right breast was huge. On 05May2021, the patient had MRI and CAT scans which showed "extensive mediastinal mass effect continuous from right to left side with greatest dimension of 10cm. Mid left pillar idiopathy and subcarinal area neoplastic disease". She was having a biopsy done today at the hospital". The patient's lymph nodes were swollen in the area between her lungs. On 05May2021, the patient had her COVID test which showed negative result. It was then reported that the biopsy was going to be either Ebus (as reported), which is where a tube was put down the throat, and if that did not work, there would be a mediastinoscopy performed and after that, there is a possibility that CAT scan will be done. The patient's husband reported that on Apr2021, the patient's right breast was diagnosed with cellulitis so the patient received a couple of IV (intravenous antibiotics) for the breast and it slightly improved. The patient's cellulitis could lead to sepsis that's why she was treated with IV antibiotics. The patient's MRI on an unspecified date showed that the patient's breast was clear of any swollen lymph nodes and potential cancer. The patient was also given IV antibiotics for breast enlargement, breast swelling, and breast infection. On Apr2021, the patient experienced side effects mass in her throat, swollen lymph nodes on her right breast, and cellulitis. The patient will be undergoing a biopsy today, because they think that patient has lymphoma. It was reported that the patient received her vaccination at a huge vaccination setup at a local high school. The patient was hospitalized for 3 days (unspecified dates) due to the events breast enlargement, swelling arm, breast swelling, breast cellulitis, and breast infection. The patient's husband also stated that the patient was brought to the emergency room for because the right arm started swelling and that the right breast was huge, then was taken to the hospital room that night. No other vaccine received within 4 weeks prior to the COVID vaccine. Outcome of the events breast cellulitis, and loss of voice was recovering, for events swelling arm and panic attack was recovered on an unspecified date, and for other events was unknown.
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| 69 | 2021-05-21 | feeling abnormal, excessive sleepiness |
Swelling in the face and lips with hives; Swelling in the face and lips with hives; Her throat did n...
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Swelling in the face and lips with hives; Swelling in the face and lips with hives; Her throat did not close up; Legs swollen; Chills; she got nauseated (intermittently, a lot of nausea); Hives all over her started as a few / really bad hives and only from the knees up; it was like she had the flu / felt ill; trouble breathing; she was so weird; Raised spot like bug bite on top of her left; she was really tired / She slept for practically the whole time the next 4 days; Weakness; the doctor said it was Covid Arm. It hurt just a little bit, no big deal. It hurt and was red around it.; the doctor said it was Covid Arm. It hurt just a little bit, no big deal. It hurt and was red around it.; Headache; This is a spontaneous report from a contactable consumer (patient). This 69 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Apr2021 in the afternoon, in left arm, for COVID-19 immunization. No other vaccine was administered on the same day. Family medical history relevant to AEs: none. Medical history included brain surgery on 27Apr2020, heart thing, allergic to latex and metals and she was overweight. She has never had a reaction to medications. She gained 40 pounds. She was at 260, and now she was 250 because she lost 10 of that. She had for 30 or 40 years (no further details provided). Concomitant medications were none. The patient got the shot and after that they did not hold her, she just left. She did not feel the injection at all, she was wondering at first if he actually gave it to her because he was very good. She went to the grocery store. She had brain surgery last year, so she was weak anyways. After having brain surgery she could shop for, like she built up to an hour, really and had no problems. She stopped for breakfast and she was fine. She got in the store and just started walking through the store. She had trouble breathing (maybe around 45 minutes to an hour after vaccination) and was leaning on the cart because she was so weird. It went away maybe the next day or the day after. She got about three things and then went to the line and got out of the store. She went home and did not remember when the spot showed up, maybe hours after before she noticed it. It was a raised spot like a bug bite on top of her left (no further details provided). She thought a spider must have bit her. Then, she went to bed and the next day she had hives all over her which were practically on top of each other. It was really bad hives and only from the knees up for some reason, none on her toes or her feet just her knees up and it was horrible. She was tired, weak, and felt ill so she stayed in bed a lot on 28Apr2021. She slept for practically the whole time the next 4 days. She went to the doctor the day after for the hives and he said it was Covid Arm. She was not sure if she was allergic to the shot itself or like a bad reaction happened here. She went in and had them check, and he searched on the internet. That was why she will not be going back to that doctor. It hurt just a little bit, no big deal. It hurt and was red around it. It was more like Covid body. She had headache on 28Apr2021 and then chills on 29Apr2021 and it was like she had the flu only she did not throw up. Chills were intermittent and on and off all day whether she was in bed or up or under a lot of covers or not. On 02May2021 she got nauseated (intermittently, a lot of nausea). She took a lot of Benadryl. She was sleeping good because she took Benadryl. She still had headaches and she woke up with it. It was kind of dull for four days. It probably came on she was going to say almost instantly but she could have been stressed about getting the shot. At the time of report it was worse than it was. She also had swelling on her face and lips on 02May2021 but she also had hives in the same spots that it was swelling. Right at the top of her forehead, and the top of her lip but she thought it may have been a hive because she had a hive on her lip and three or four on her forehead. She thought it was more than that and there was swelling because she was allergic. Her throat did not close up. She had legs swollen on an unknown date in May2021. She did not think this had anything to do with the shot. She did not think it was from an allergic reaction on that part. She thought she was probably allergic to it because she had so many hives. She was scared to death of getting the second one. She was feeling really good when she walked in, she was walking good and everything, and she went out to eat and the store. It was quite long but truthfully when she got out of bed, she would just go to her couch. As of last night, the trouble breathing was there but she had not been up long enough to see. She was going to therapy later. She was very vivid because she was doing so much better because of the operation. She was still feeling weak but sometimes it got better and then she got weak again. Her body was compromised and everything because of her operation. She wanted to get the shot because she did not go out many places. Hives all over her started as a few, so she went to the doctor because it was quite a few. The next day, they were so much worse. The patient stated she sounded like she was hypochondriac. Benadryl was all she took for treatment and took it as often as the box allowed, she thought 2 every 4 to 6 hours. The events did not require ER visit. Relevant tests: none. Chills lasted about five days off and then went away on 03May2021. Hives resolved on 05May2021. Swelling in the face and lips resolved on an unspecified date in May2021. Headache and legs swollen had not yet resolved. The other events outcome was unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-05-24 | loss of personal independence in daily activities |
Pain in shoulders, back and hips which has increased starting 3/28/21. This is a disruption of my ...
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Pain in shoulders, back and hips which has increased starting 3/28/21. This is a disruption of my ablility to conduct normal life functions including my ability to walk. My treatment includes lab work which shows I may now have inflammatory arthritis which I have never been diagnosed with before. I have had physical therapy for this which was not successful.
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| 69 | 2021-05-26 | insomnia |
chills; Fever; Achy; had a hard time sleeping; did not feel well; headache; Arm was sore; This is a ...
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chills; Fever; Achy; had a hard time sleeping; did not feel well; headache; Arm was sore; This is a spontaneous report from a contactable nurse reported for herself. This 69-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171) via an unspecified route of administration in the left arm on 10May2021 at 16:00 for COVID-19 immunization. Medical history included chronic pain from multiple back and hip surgeries, 8 surgeries in 10 years, it seemed like it was every January; Covid in January. Concomitant medications included atorvastatin for cholesterol for about 2, maybe 3 years; ergocalciferol (VIT D) for osteoporosis for 5 years; gabapentin for a couple of months for nerve pain; medical marijuana since she had multiple failed fusions and 8 surgeries in 10 years, calcium. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8731) via an unspecified route of administration (injection in the left arm) on 19Apr2021 for COVID-19 immunization, experiencing Arm was swollen and sore, felt achy, headache and fever. The patient previously received Trumemba meningococcal vaccine about 2017 and had seizures. The patient had an aneurysm on an artery to her spleen and had to have surgery. Since it was on her spleen it affect her immune response. She had to get a bunch of vaccines, that was one of them. The other was pneumococcal and other ones. She just had like under the weather feeling but not horrible from the meningococcal vaccine. After the second vaccine, the patient experienced arm was sore, headache, fever, chills, achy. Around 8 o'clock on 10May2021, her arm was getting sore and she was getting a headache. This was a quicker response than the first vaccine. She had a hard time sleeping. When she got up this morning, she knew she had a fever. She took it first thing and it was 100.4. She got up and had something to drink and then it took her about an hour and a half to get something to eat. Her temperature went up to 101 a couple of hours after that. She waited two hours and caved and took tylenol. The patient reported that that one dose helped her not to feel so chilled, achy and feverish. The patient stated that the CDC Website and the paperwork on the vaccine does not say if it was okay to take Tylenol afterwards. Event websites said to contact healthcare provider but she did that and she cannot get through. She ended up taking 600, 2 regular strength - the patient stopped the sentence and stated she actually took 650 mg of Tylenol and then her temperature came down to 99 and she felt better. The patient stated said she had to do this. She felt too sick. She hoped that it was okay. She called her local health department and they transferred her to the vaccine line. It was automated and she could not get a person to ask if she could take Tylenol. The patient added she still had a sore arm there, but at this point, knock on wood, it was not as bad as it was the first time. She tendedto sleep on her right side more. It was sore. It was not like horrible. It was not like she can't use it, because she can. The worse thing was that she was achy and under the weather with a low grade fever which she heard people get but none of her friends have. None of them had Covid. She waited over 3 months for the vaccine because her husband's doctor, a doctor she did not see, said do not get it too soon because people get more of a reaction if they got it too soon. He said wait three months, so they waited 3 and a half months. About chills and achy, the patient did not feel as cold right now so she knew the Tylenol helped. She was starting to get warm and was wearing a few sweaters. She expected something and she will be grateful if this was as bad as it got. She did not take a lot of Tylenol because she did not like to take too much of anything so she tried not to take anything again until later if needed. The patient stated there was no question that the second set of symptoms were caused by the vaccine. The patient added that the second set of symptoms were also not life threatening and confirmed as not serious. The patient confirmed as left arm was sore, the arm where she received injection. She guessed everything she had experienced was actually medically significant because of the fact that Pfizer wanted people to report things like this. The patient stated she had her vaccine card but was not sure why she might need it, going forward it might be important to have for various things. The patient received a chest x-ray at the end of February, and she just saw pulmonologist and had to go back for a pulmonary function test. The patient confirmed this was from before the vaccine and to follow up after she had had Covid, it was a formality. It was not from the vaccine, it was from the virus. The event did not required a visit to Physician office or Emergency Room after the vaccines. The patient was nervous to get bnt162b2, but was happy to make it through the first one. Now, she was on day 2 of the second one and as long as she can take Tylenol to help with the symptoms she will be okay she things. She did not think she was getting worse. These kinds of things come in waves. The patient added that she would not have been able to talk to call handler three hours ago because of the fever and achy and dizzy and everything. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021533417 same patient/drug, different dose/event
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| 69 | 2021-05-27 | insomnia |
she saw stars; arm soreness in her left arm/same arm is sore after the 2nd shot and she did not even...
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she saw stars; arm soreness in her left arm/same arm is sore after the 2nd shot and she did not even get the shot in that arm for the 2nd dose; Headache; Chills; Was very cold; Couldn't sleep last night; Swollen; This is spontaneous report received from a contactable nurse (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in the right arm, at age 69 years, on 11May2021 at about 12-12:30 in the afternoon (lot number: EW0170) as 2nd DOSE, SINGLE for COVID-19 immunization, patient did not have choice for getting COVID-19 vaccine as it was mandatory for school. She did not want to get it but, she did what she had to do. Relevant medical history includes blood pressure measurement (unspecified), cholesterol, dyspepsia/heartburn, and Gastrooesophageal reflux disease (GERD) from unspecified dates. Everyone in her family that she knows did not have much many problems at all like she did. Concomitant medications included amlodipine taken for blood pressure measurement (unspecified) from an unspecified start date and ongoing at 5 mg per tablet, by mouth, once daily; pravastatin taken for cholesterol from an unspecified start date and ongoing at 20 mg per tablet, once at night, by mouth; esomeprazole magnesium (NEXUM) taken for dyspepsia/heartburn and GERD from an unspecified start date and ongoing at 40 mg per capsule, by mouth, once a day. No additional vaccines was administered on the same date as Pfizer suspect. Patient historically received first dose of BNT162B2 (Lot number: ER8734) on 20Apr2021 for COVID-19 immunization and experienced soreness at her injection site/arm would be sore, arm was also bruised and swollen, headache, tired, fever, and muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking. Patient reported that she had her 2nd shot yesterday and had a crazy reaction. After talking to her Pharmacist, he recommended that she should call Pfizer to see if this was something that she should report. Patient reported that after the second injection on 11May2021, she had arm soreness in her left arm but, it was in the opposite arm she got the injection. It was really strange. After her first shot her arm was killing her, it got swollen and it was bruised. That same arm is sore after the 2nd shot and she did not even get the shot in that arm for the 2nd dose. It was the craziest thing she knew her arm would be sore after the shot but, not the opposite arm. For the first dose, patient had soreness at her injection site after the 1st injection. Arm was also bruised and swollen. Left arm: She got it 12 in the afternoon but, the stuff showed up 5-6 hours later, nothing right away. It was the same yesterday with her shot, she was ok and about 6-7 hours after is started bothering her. She got the 1st injection on 20Apr2021. She knew her arm would be sore. She checked off everything on her a list she got from the pharmacy; she had fever, her muscles were sore enough where she had a difficult time walking, her arm was sore after the first shot. She figured after the second shot the arm she got the shot in would be sore but, it was the opposite arm. It was improved but it started happening again after the 2nd shot. She reported that she couldn't sleep last night, it hurt, every time she rolled over on it and she saw stars. Outcome: She reports its about the same, she is not leaning on it but, it was sore and swollen yesterday. The swelling is down a little bit today. Patient doesn't know if the antibodies gravitated to that arm or what. Patient reported that she had headache, was tired, muscle soreness to where she couldn't even walk that happened after her first shot on 20Apr2021 was improved but some started happening again after the 2nd shot. She did not have a fever after the 2nd dose but, had a headache, chills, she was very cold and arm soreness in the left arm. She mentioned that she had a hard time with both of the shots, she is glad Pfizer only has 2. She is still doing things still, she is a little sore today it may be a few more days until it clears up. Patient thought she would switch up the arm for the 2nd dose as to not agitate it but, she ended up doing it anyway, agitating the arm of the 1st dose injection. No treatment was sought. The AEs did not require a visit to emergency room or physician office. The outcome of the event swollen was recovering, for arm soreness in her left arm/same arm is sore after the 2nd shot and she did not even get the shot in that arm for the 2nd dose it was not recovered, while for the other events, it was unknown.; Sender's Comments: Based on temporal relation and available clinical data, a causal relation between the reported events and vaccination with BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-05-28 | anxiety |
dizziness, heart palpitation, and anxiety after 1-2 minutes; dizziness, heart palpitation, and anxie...
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dizziness, heart palpitation, and anxiety after 1-2 minutes; dizziness, heart palpitation, and anxiety after 1-2 minutes; dizziness, heart palpitation, and anxiety after 1-2 minutes; my heart racing/palpitating like having an anxiety attack; my heart racing/palpitating like having an anxiety attack; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, solution for injection, Lot Number: Unknown), via intramuscular route of administration in left arm on 31Jan2021 11:45 1st dose, single for covid-19 immunisation. The patient medical history included fibromyalgia, arthritis, postnasal drip and allergy to penicillin, sulfa drugs, dust mites, some trees. Concomitant medication included Bupropion, Trazodone and Lamotrigine; all were taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not COVID tested post vaccination. On 31Jan2021 at 11:45 AM the patient experienced dizziness, heart palpitation, and anxiety after 1-2 minutes. About a minute or two after the shot, I experienced dizziness, my heart racing/palpitating like having an anxiety attack, which I rarely have. It lasted around 15 to 30 minutes. A doctor was on hand. An assistant checked my heart rate and blood pressure and was told it was fine. Patient did not receive any treatment for events. Patient had blood pressure/pulse taken. Outcome of the events was recovered on 31Jan2021. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 69 | 2021-05-28 | sleep disorder, feeling abnormal |
2nd shot on March 9. March 10 had terrible headache, felt awful, lack of sleep night before & durin...
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2nd shot on March 9. March 10 had terrible headache, felt awful, lack of sleep night before & during day, injection site swollen & pain lasted a good week, tiredness lasted several days, and by March 11-12 noticed buzzing in ears (mainly right).
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| 69 | 2021-05-31 | impaired work ability |
Arm turned red, swollen up like a huge baseball in arm, itched, hot, very sick: fever, flu-like sym...
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Arm turned red, swollen up like a huge baseball in arm, itched, hot, very sick: fever, flu-like symptoms, unable to work for 3 weeks.
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| 69 | 2021-05-31 | nervousness | Shaky, dry mouth |
| 69 | 2021-06-01 | sleep disorder |
she is rickety, and as she starts moving, she is ok, not in pain; legs and arms ache; inflammation r...
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she is rickety, and as she starts moving, she is ok, not in pain; legs and arms ache; inflammation rate was a little high; it is hard to sleep; legs and arms ache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E10142, Expiration date: not reported), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021 the patient experienced adverse events reported as "she is rickety, and as she starts moving, she is ok, not in pain, she had legs and arms ache, inflammation rate was a little high, it is hard to sleep." The patient wanted to know if anyone else has the same symptoms, and should she be getting the second dose. The patient underwent lab tests and procedures which included blood test normal, inflammation rate a little high on 26Jan2021.The outcome of events legs and arms ache, Crepitations was not recovered and for inflammation, hard to sleep Was unknown. Follow-up attempts are completed. No further information is expected.
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| 69 | 2021-06-03 | disturbance in attention |
Chills; body aches; HA; rash (not uncomfortable); metallic taste; dizziness; difficulty focusing; Th...
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Chills; body aches; HA; rash (not uncomfortable); metallic taste; dizziness; difficulty focusing; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in arm left on 04Mar2021 at 16:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included tetanus, known allergies: sulfa, red nail polish, and COVID prior vaccination. Concomitant medications included bupropion. The patient did not receive any other vaccine in four weeks. The patient previously took percocet (oxycodone hydrochloride; paracetamol) and linzess and experienced known allergies. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021 at 18:30, the patient experienced chills, body aches, ha (headache), rash (not uncomfortable), metallic taste, dizziness and difficulty focusing. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 69 | 2021-06-03 | feeling abnormal, irritability |
pain at the sternum base; breathing problems; Diarrhea; Chills; Slight fever; Possible swollen lymph...
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pain at the sternum base; breathing problems; Diarrhea; Chills; Slight fever; Possible swollen lymph glands; Red arm; brain fog continued; Increased irritability; Vomiting; Extreme dizziness; Swollen, red arm; This is spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via unspecified route of administration in the left arm on 03Mar2021 at 21:00 as a single dose for COVID-19 Immunisation (at the age of 69 years age at vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included gastroesophageal reflux disease (GERD) and hypothyroidism. The patient was allergic to the Penicillin and most of the antibiotics and always had a problem with flu vaccine so since retired don't get it or other vaccines. The patient's concomitant medications included pantoprazole 20mg (MANUFACTURER: UNKNOWN) and levothyroxine112mg (MANUFACTURER UNKNOWN).The patient experienced swollen, red arm, vomiting, diarrhea, extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog on 04Mar2021 at 03:00am and she had to be in bed for almost 40 hours. The patient also experienced repeat of extreme vomiting, diarrhea and breathing problems secondary to pain at the sternum base on 14Mar2021. No Therapeutic measures taken for the adverse event. At the time of the report the clinical outcome of the events swollen, red arm, vomiting, diarrhea extreme dizziness, chills, slight fever, possible swollen lymph glands, increased irritability and brain fog were recovering and the events breathing problems and secondary to pain at the sternum base were unknown. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-06-09 | anxiety, nervousness |
69 y/o with past medical history of HTN, Heart attack, Asthma, Gastritis, Spinal Surgery x2 and Bell...
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69 y/o with past medical history of HTN, Heart attack, Asthma, Gastritis, Spinal Surgery x2 and Bells Palsy who presents with nervousness prior to vaccination and then worsening anxiety, nausea and dizziness immediately post vaccination. Patient states that this is the first dose in the two-dose series. Patient states that she received the vaccination to the left arm. Patient denies headache, sore throat, difficulty breathing, shortness of breath or chest pain. Patient evaluated by NP and Paramedics. Patient started complaining of difficulty breathing, so patient was placed on 2L O2 by nasal cannula. Patient initial vitals with hypertension present (176/99 BP, 65 HR, 99% RA). Patient states that blood pressure medication was taken this am. Patient states nervousness and fear of needles maybe the cause of symptoms. Patient monitored for 20 mins with resolution of symptoms. Patient was weaned off O2 with no further complaints of difficulty breathing. Patient denies nausea and dizziness. Patient BP upon discharge within normal limits, 142/78. Patient discharged in stable condition.
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| 70 | 2021-01-04 | feeling abnormal |
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was ...
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Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
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| 70 | 2021-01-08 | anxiety |
patient feeling flushed & light headed. Onset occurred about 10 mins after vac Vitals monitored; no ...
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patient feeling flushed & light headed. Onset occurred about 10 mins after vac Vitals monitored; no swelling throat/face. After calming patient, symptoms subsided. Called Dr. for release/review. 71 y/o female who presents with facial flushing & light headedness that began after her vaccination. No progression or other symptoms. Hx of similar RXN after exercise symptoms. P.E - Mild facial flushing started Possible mild allergic rxn. Plan - home with monitoring.
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| 70 | 2021-01-08 | impaired work ability | Headache extreme fatigue, did not work yesterday; Narrative: |
| 70 | 2021-01-09 | impaired work ability | Missed X1 day of work due to fatigue, felt better next day |
| 70 | 2021-01-11 | feeling abnormal |
very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a con...
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very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL4238, Expiration date: 30Apr2021), via an unspecified route of administration at site of right arm at 14:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high cholesterol for several years. Concomitant medication included rosuvastatin calcium (CRESTOR) for cholesterol (had taken it for several years). The patient had a bad headache and feels terrible at 6 am on 07Jan2021, she wanted to know if she could take something for the headache. She got up at 6 am and feeling bad on 07Jan2021, she left for work and came home, and she was sick. Her feeling terrible started sometime during the night. She was feeling fine on 06Jan2021. These events were identified as non-serious by reporter. Vaccination Facility Type was in public health department. Vaccine was not administered at military facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. No adverse events required a visit to emergency room. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The outcome of events 'headache' was not recovered; of rest events was unknown.
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| 70 | 2021-01-11 | feeling abnormal |
Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and...
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Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and felt jittery, lightheaded, sweating, numbness/tingling in both hands, feeling strange
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| 70 | 2021-01-11 | insomnia, abnormal dreams |
joint and muscle pain all over; joint and muscle pain all over; She had weird dreams, very strange d...
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joint and muscle pain all over; joint and muscle pain all over; She had weird dreams, very strange dreams, and couldn't sleep; She had weird dreams, very strange dreams, and couldn't sleep; still has a problem lifting her left arm that she received the injection in; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscular on 06Jan2021 at 11:30 at single dose in left arm for covid-19 immunization. Medical history included coronavirus in Nov2020. The patient's concomitant medications were not reported. The patient reported that She had her first dose of the Pfizer Covid Vaccine yesterday at 11:30 am. She had a really bad reaction. She was fine and then all of sudden her joints and muscles hurt a lot all over. She wanted to find out what she could take for the pain. Treatment: She took aspirin. Reported she had a lot of pain, every joint and muscle hurts in her body. The pain did not start right away, she was fine at first and then the pain started all of a sudden. She had weird dreams last night and could not sleep all night. She still had a problem lifting her left arm that she received the injection in. She wanted to know if it was ok to take aspirin or something better like Tylenol. She wanted to know what she could take. Reported she had coronavirus in Nov2020. The outcome of events joint and muscle pain all over was resolving, outcome of other events was unknown.
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| 70 | 2021-01-14 | impaired work ability | fever, aches. called in sick to work. |
| 70 | 2021-01-21 | restlessness |
Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 h...
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Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 hours was lingering headache, fatigue, but improved from day before.
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| 70 | 2021-01-24 | sleep disorder |
3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, r...
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3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; his arm remains very tender to touch; Lost sleep due to pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EJ1686, expiry date unknown) intramuscular at the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination; HTN, High cholesterol, and Asthma, all from an unknown date. The patient is not pregnant. Concomitant medications included ASA, carvedilol, ferrous sulfate, losartan potassium, magnesium, rosuvastatin, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D, pantoprazole sodium sesquihydrate (PROTONIX), budesonide, and formoterol fumarate (SYMBICORT). The patient had previous allergies with Zocor, Prolia, Evista, Daypro, Amlodipine, and Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021, 12:00 PM, the patient experienced 3in x 3in lump at the injection site, red in color and hot to touch. She lost sleep due to pain, his arm remains very tender to touch. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site mass, vaccination site erythema, vaccination site warmth and vaccination site pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-01-25 | impaired work ability |
Patient self-reporting through the hospital's electronic reporting system. In her own words, "Recei...
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Patient self-reporting through the hospital's electronic reporting system. In her own words, "Received 2nd Pfizer COVID-19 Vaccine. Beginning 17 hours later, I had extreme weakness, headache, chills and fever. I had to take off Friday, January 22, 2021, from work because of not feeling well. I still am not feeling well".
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| 70 | 2021-01-26 | nervousness |
Patient received first dose of COVID vaccine. Approximately 10 minutes later patient was experiencin...
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Patient received first dose of COVID vaccine. Approximately 10 minutes later patient was experiencing palpitations, dizziness and lightheadedness. Brought patient to exam room to be seen by onsite provider, BP: 130/70 Pulse: 122-140 Oxygen saturation 98% No rash, no hives. Reports no SOB however increased work of breathing. Patient felt increasingly dizzy and felt shaky. Patient had near syncopal episode. EMS was called and patient taken to ER.
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| 70 | 2021-01-29 | depression, feeling abnormal, irritability |
Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, bu...
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Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, but no vomiting. Was able to eat. Day 4 (today) fever, chills and diarrhea - feel a little better than yesterday. Still able to eat ok. I have not contacted my healthcare provider about these symptoms because it is the weekend. If I still have symptoms on Monday, I will call him. In the meantime I?m taking Tylenol for the fever and drinking water to stay hydrated.
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| 70 | 2021-01-30 | feeling abnormal | Stomach ache, nausea, dry heaves, headache fever(101.3) chills body aches, headache, brain fog |
| 70 | 2021-01-30 | insomnia |
12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight ...
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12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight feverish feeling slight nausea,, which lasted ...then just turned into flu like feeling...insomnia with body feeling slightly jittery till 4am ,took nighttime cold tablet. Flu like symptoms till 31st am.
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| 70 | 2021-01-31 | memory impairment, disorientation, confusional state |
woke up disorientated and confused on 01/25 at 3 am and she is still in the ER in ICU and does not r...
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woke up disorientated and confused on 01/25 at 3 am and she is still in the ER in ICU and does not recognize anyone, she is very strong an d trying to leave hospital and pulling out IV's and catheters
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| 70 | 2021-02-03 | loss of personal independence in daily activities |
bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl a...
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bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills.
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| 70 | 2021-02-04 | feeling abnormal |
she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; she did ...
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she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jan2021 at single dose for Covid-19 immunization. Medical history included high blood pressure, acid reflux, allergy. Concomitant medication included lisinopril for high blood pressure, oxymetazoline hydrochloride (CLARITIN ALLERGIC) for allergy, cetirizine hydrochloride (ZYRTEC ALLERGY) for allergy, omeprazole magnesium (PRILOSEC) (reported as it's like Prilosec) for acid reflux. Patient received the first vaccination on the 15Jan2021 and she did not have any symptoms until Tuesday (19Jan2021), she started feeling kind of bad, she was very prone to allergies, she just thought it was back, this was her season to get sick if she had to get allergies, this was when it happened like January early February, so she went to Urgent care and she wanted a cortisone shot and she didn't think she should get a cortisone shot because it would effect the effectiveness of vaccine, so they said no and they would like to swab her nose to rule out that she didn't have COVID, and he did and it came out positive, so she wanted to get our opinion that if we thought it was a true positive or false positive. She thought she couldn't get COVID after she got the part of vaccine, and the second question she had was her second dose would be on 05Feb2021 by that she would be out of quarantine so should she plan and take the second one. Patient guess the lot number was EL0142. Th outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-02-05 | feeling abnormal, sleep disorder |
Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By ...
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Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By 3am, had fever, chills, couldn't stop shaking or get warm, had headache, skin sensitive almost hurt when touched. Felt too bad to get out of bed but eventually got up, took acetimetophen, drank water, added clothes and blankets and returned to bed. Body kept tensing up very tightly so that all muscles were constricted/tights and impossible to relax. This continued for a few hours. By morning, I thought I was starting to feel better. These symptoms returns for a second round about 2pm that afternoon and continued until about 6pm. On the nights of 2/3, 2/4 and 2/5, I wake up around 3am extremely hot and sometimes damp, despite air temp of 66 to 68 degrees. This resolves after about an hour and body feels normal.
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| 70 | 2021-02-05 | feeling abnormal | Chills, 6 hours, body aches 24 hours, headache 24 hours, foggy brain 24 hours |
| 70 | 2021-02-06 | anxiety |
after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling ...
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after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling numb and tingly, was taken to ER as it was part of the same building in a wheel chair, was also anxious, nauseated and had dry heaves and blood pressure was elevated. Received IV solumedrol, ativan and zofran and then later oral benadryl. I was told to contact my PCP to see if I should get the second vaccine and he indicated no.
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| 70 | 2021-02-06 | excessive sleepiness | None stated. |
| 70 | 2021-02-07 | feeling abnormal |
due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but s...
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due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but she tested positive for COVID yesterday; Dizzy; starting to get foggy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899 or EH9897), via an unspecified route of administration at the left arm on 04Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing diabetic, blood pressure high, high cholesterol and sore arms from previous vaccines (unspecified).She had energy for a whole week after getting the vaccine, that she has not had for a long time, she even cleaned out her whole garage; has been waiting to do that for 3 years; had to make herself stop to rest. There were no concomitant medications. The patient got her first dose on 04Jan2021 and was due to get the 2nd dose this coming 25Jan2021, but she tested positive for COVID on 21Jan2021. She has been sick for a week which started with an irritating cough on 14Jan2021. She went to the ER because she was dizzy as could be on Jan2021. She does not remember which day; she was starting to get foggy on Jan2021. She was not admitted. She did a drive through rapid test on 21Jan2021 and it was positive. Lot numbers: Handwriting on her card was bad and she cannot tell if the last digit of the Lot number is a 9 or 7. The vaccine was administered in an open tent clinic outside in a parking lot outside a hospital and not in a military facility. The outcome of the event was unknown. Information on Lot/Batch has been requested.
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| 70 | 2021-02-08 | feeling abnormal | Vomiting, diarrhea, chills, fog head, tiredness, slight sore arm |
| 70 | 2021-02-08 | feeling abnormal | fatigue, headache, muscle & joint aches, mental fog |
| 70 | 2021-02-10 | feeling abnormal, amnesia |
brain fogginess; Short term memory loss; tired; This is a spontaneous report from a contactable cons...
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brain fogginess; Short term memory loss; tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 18Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: unknown. Medical history included high blood pressure, asthma, hypothyroidism, prediabetes and allergies to penicillin (possibly), clindamycin, levofloxacin (LEVAQUIN) and environmental allergies. Concomitant medications in two weeks prior to the vaccination included high blood pressure, asthma, prediabetes and thyroid medications. Prior to vaccination the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 19Jan2021 at 09:00 AM patient experienced short term memory loss, repeated same sentences many times in short amount of time (>7x), tired and brain fogginess. No treatment received for the events. It was also reported that post vaccination the patient had been tested for COVID-19. Test Name: PCR (Nasal Swab) on 20Jan2021 with negative results. Patient recovered from the events on unknown date. Information about lot/batch number has been requested.
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| 70 | 2021-02-13 | loss of personal independence in daily activities |
I had the sho, the second, one, in the evening and I was fine. Next morning, about 14 hours later I...
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I had the sho, the second, one, in the evening and I was fine. Next morning, about 14 hours later I woke up ( 5 AM ) and my hands were really swollen, with pain in my distal joints in particular, I could not even close my hands around a spoon to put sugar in my coffee. There was pain on palpation of my bones in my hands. There was pain in my knees and my ankles. Really weird, I have no arthritis at all. However, it was the very same reaction I had when I initially took Ceclor, an old antibiotic about 20 years ago. 4 /6 hours later it had all disappeared! 24 hours after the vaccine, when I had almost forgotten about the morning, I suddenly had fever (37.9) and moderate chills! It also started from nowhere as I was watching TV at the time. I took a Tylenol and went to bed. Next morning I was fine and felt wonderful. I am a physician myself and it was really surprising for me. The arm had no pain, nothing at all, but the chills were disturbing. I am fine and happy now. I have taken ALL the vaccines available and never had a reaction like this, including rabies, and each and every vaccine I had to take. I am absolutely fine and happy and thankful.
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| 70 | 2021-02-14 | nightmare |
I have never had this before, but since getting the vaccine, I have had horrible nightmares every ni...
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I have never had this before, but since getting the vaccine, I have had horrible nightmares every night since getting the Pfizer vaccine. My husband has to wake me every night, and this has not let up. Also, I have had a Fibromyalgia flare-up since getting the vaccine.
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| 70 | 2021-02-15 | sleep disorder |
Right arm became very sore 2 hours after vaccination. But no rash or swelling. Soreness gradually g...
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Right arm became very sore 2 hours after vaccination. But no rash or swelling. Soreness gradually got better over 4 days, but soreness returned 1 week after vaccination and has persisted to current time which is almost 3 weeks since receiving shot. Interferes with sleep. Tylenol helps. Still no swelling or rash.
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| 70 | 2021-02-16 | loss of personal independence in daily activities |
woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle wea...
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woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle weakness, could hardly sit up by myself, this was 2/11/21. I continued to feel these symptoms with lessening severity over the next 3 days until Sunday 2/14/21 at which time, late in the afternoon, I fell asleep and woke up drenched in sweat but feeling pretty much back to normal self and have felt normal self since then.
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| 70 | 2021-02-17 | fear |
shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this wa...
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shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this was the 4th time; kidney infection; hurting on my waist around the back; diverticulitis; Her blood pressure went up to 211/92; does not feel well; afraid of taking it if it will be any worse; sick; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot: EL3248, expiry 30Apr2021), intramuscular on 23Jan2021 08:15 at a single dose in the left arm for COVID-19 immunization (prevention because she has autoimmune). Medical history included Behcet's syndrome and Sjogren's syndrome, both are overactive immune system problem/autoimmune diseases, which were diagnosed 20 years ago; diagnosed allergies; compromised immune status; respiratory illness; genetic chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; and patient have had shingles before. Family history was reported as none. Concomitantly, she was just taking daily medications that were not relevant. There was no prescriber for the vaccine. It was through a hospital. It was reported that vaccination was given at 08:15 to 08:30. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered the same date of the Pfizer suspect. Patient had not had prior vaccinations (within 4 weeks). Patient received her first dose of the Pfizer vaccine on Saturday 23Jan2021. She stated, on Tuesday 26Jan2021, patient was hurting on the waist around the back. On Wednesday, 27Jan2021, that next morning, she went to see her internal doctor and they thought a kidney infection or not; he was not sure if she had a kidney infection or what was going on. Patient went home and it got worse and patient went to the ER (Jan2021), also reported as ended up going to the ER. They did a CT scan gave her medicine. They did a CT scan and said it was not her bladder or anything (Jan2021). They thought it was diverticulitis; nothing helped. They gave her medication and she kept getting sick (2021). No further details provided on medication given. On Friday, 29Jan2021, early morning, patient went back to the ER, they did another CT with contrast it wasn't diverticulitis, but it was shingles, and patient have had shingles before, this was the 4th time. It was reported that when the doctor came in, he thought this was shingles and she has had shingles previously. She has had it about 3 other times and the pain was just off the scale (Jan2021). Her blood pressure went up to 211/92 and they were giving her morphine for the pain (Jan2021). She was questioning if she should get the second dose. She has two autoimmune diseases and it was an overactive immune disease. She took the one vaccine and her doctor said to contact Pfizer being as it is kind of new and especially since she has the autoimmune issues. She would like to know if it is safe for her to have the second vaccine. She does not know if she will be over this. She does not feel well (Jan2021). She was afraid of taking it if it will be any worse (Jan2021). Patient felt all right until she had the vaccine, on Tuesday the problem started (26Jan2021). They were giving her medication for the shingles and for the pain. Patient stated that "it set something off". Patient was still sick (2021), still taking pain pills. Patient didn't know how many days she has. Her second vaccine is on 13Feb2021. As sick as she has been, and her overactive immune system and if she still has the shingles those can last a long time, she doesn't want to go through what she went through. This was a lot of pain and with shingles they can last, 6 months or a year. The nurse called her back and told her to report to Pfizer. Patient was taking the medicine for the shingles right now. She doesn't know what will happen. She doesn't want to be sick. Patient asked for the efficacy after 1 dose and how much protection it has. She did fill out something because she talked with someone else. She confirmed it was through VAERS and not with Pfizer. She said the pain around her waist was a little better because they gave her the medicine for shingles and she has pain pills. She said one was Valacyclovir and she could not remember the name of the other. Patient had required two trips to ER. First one was on 27Jan2021 and went to internal medicine doctor and that night went to the ER. They did CT scan and it was not bladder or anything. Second visit on 29Jan2021 and did CT with contrast and the doctor thought it was shingles since she had shingles three times before. She has had them internally. The doctor said it would not necessarily need to be externally break outs. The next two times she did not break out. She did not have anything around her waist. Therapeutic measures were taken as a result of the events hurting on my waist around the back, kidney infection, diverticulitis, shingles, and sick. The outcome of the event hurting on my waist around the back was recovering. The outcome of the event kidney infection, diverticulitis, shingles, sick, blood pressure went up to 211/92, does not feel well, and "afraid of taking it if it will be any worse" was unknown.
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| 70 | 2021-02-18 | anxiety |
Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in...
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Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-02-18 | anxiety |
I felt fine for the first 5 minutes after my Pfizer shot (my first shot), but then started to have r...
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I felt fine for the first 5 minutes after my Pfizer shot (my first shot), but then started to have rapid heartbeat, anxiety and felt warm. The nurse checked my breathing and checked for rashes and said it was not an anaphylactic reaction. Symptoms subsided after 5 or so minutes and I went home and have not had further side effects. But my question is, should I get my second shot in 3 weeks?
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| 70 | 2021-02-18 | disorientation, confusional state | muscle and bone pain, chills, irregular glucose levels, extreme confusion and disorientation |
| 70 | 2021-02-19 | impaired work ability, disturbance in attention |
Shingles symptoms within 24 hours of vaccination: rash on lower mid-back, right side; headache, sens...
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Shingles symptoms within 24 hours of vaccination: rash on lower mid-back, right side; headache, sensitivity to light, fatigue. Saw Dermatologist 02 /11/2021, perscribed Valacyclovir,. This was 2nd bout with Shingles, first experienced in May 2020, two months after onset of COVID-like symptoms which commenced on March 9th, severe for 14 days. Gradual improvement of COVID symptoms (cough, difficult in breathing) after 21 days. Headaches, body aches, difficulty in concentrating, extreme fatigue continued 5 months through August 2020 and resulted in me taking Leave from full-time job. COVID antibody test 13 weeks after onset of COVID symptoms was negative.
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| 70 | 2021-02-21 | insomnia |
it felt like the reaction i generally have had with steroid injections for my spine. I was wide awa...
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it felt like the reaction i generally have had with steroid injections for my spine. I was wide awake all night. By the following afternoon I was exhausted and no longer feeling that effect. Nothing was done since it did not last. It was suggested that I report it since it is not mentioned as a side effect in the list of information.
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| 70 | 2021-02-21 | sensation of foreign body |
5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itchi...
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5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itching in her throat, lump in her throat, hives/redness noted on throat and chest. RRT responded and accompanied patient to ED
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| 70 | 2021-02-22 | feeling abnormal |
Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started...
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Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started on left arm, moved to right arm. Small round raised bumps on lower, inside of left forearm (about 3-4.) Then gastoinstestinal symptoms with diarrhea (second bout more severe.) Subtle red coloration on trunk that when stroked with finders turned white. Trunk itching, genitals itching. Hot burning hands, feeling of unease. The symptoms have lasted for days. Injected on 2/5 still having symptoms on 2/23. Taking Benadryl.
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| 70 | 2021-02-22 | restlessness |
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g...
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2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
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| 70 | 2021-02-22 | sleep disorder |
When I left facility I had a mild headache. After getting on the highway face turned beet red with ...
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When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.
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| 70 | 2021-02-23 | disturbance in attention, disorientation |
3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visio...
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3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visions when eyes were closed, fatigue, VERY loud ringing in ears, tight chest, puffy eyes, heart racing & pounding 5th day:Diarrhea, fatigue
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| 70 | 2021-02-23 | sleep disorder |
A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizur...
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A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizure because my lack of control was evident in my movements. With my heaviest PJs on, it took 8 blankets to finally warm me up. I am on a CPAP machine but I was having a hard time getting my breath. I was also nauseous but never threw up. I finally got back asleep a little after 3 am but woke several times after that. This morning, I had a terrible headache and can't get rid of it. Although I feel better than last night, I feel lousy. It is now 2 pm and I just want this to be over. On the first shot, I didn't have any reaction at all.
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| 70 | 2021-02-24 | anxiety |
Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vacci...
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Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vaccination waiting period, patient became unresponsive and exhibited convulsion like movements in her waiting chair. Pharmacist quickly evaluated patient and patient was only minimally responsive to painful stimuli only. Breathing was rapid, shallow, and irregular with an expiratory wheeze heard upon auscultation. Patient was slouched in chair but supporting self and had a strong grip with her left hand. Skin condition was warm but diaphoretic. Ambulance 911 service was called. No swelling of the throat, mouth, face, nor lips was seen. Patient continued to be non-responsive, with non-comprehensible sounds, and was not opening eyes or following commands. Due to worsening ability to breath and wheezing on expiration, epinephrine 0.3 mg was administered intramuscularly into the left thigh at 1230 on 2/25/2021. Approximately 5 minutes after epinephrine administration, the patient?s work of breathing improved, wheezing was diminished upon expiration, and respiratory rate had slowed to 16 breaths per minutes. BP was 160s/80s and HR 98 (after epinephrine administration). Patient began opening eyes spontaneously but was still not following commands. Ambulance service then arrived, report was given, and patient was transported to Hospital Emergency Department. Patient was under the care of Doctor at the emergency department and received albuterol/ipratropium nebulization, dexamethasone 10 mg Iv, famotidine 20 mg IV, and magnesium sulfate 2 g IV. After the physician evaluated the patient and talked with family, the patient?s family stated that the patient has a history of anxiety related reactions such as this with convulsion like activity. Doctor then determined that the patient did not have an anaphylactic/allergic reaction and instead had a anxiety related vasovagal type reaction. Doctor stated that the patient could receive the second COVID-19 vaccine dose in 3 weeks without issue. Patient then discharged from Emergency Department (unsure if AMA). Patient then presented to the pharmacy with her daughter after discharge to fill in staff on the outcome of the reaction. Patient appeared to be at baseline mentally and physically. Pharmacist contacted Emergency Department to discuss case with patient?s nurse to obtain information about medications received in the emergency department. Patient daughter stated that she would like to be present for second dose of vaccine to help avoid a similar anxiety related reaction from occurring.
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| 70 | 2021-02-24 | feeling abnormal | Dizziness; faint; feeling of falling off my chair; vision went black. |
| 70 | 2021-02-24 | excessive sleepiness |
did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; ...
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did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.
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| 70 | 2021-02-24 | loss of personal independence in daily activities |
Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep fo...
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Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep for about an hour - we were not able to complete simple tasks and went to bed early. My husband was up every half hour urinating from 6pm until about 3am. We both felt fine this morning but about 11am I got super dizzy and had to sit down, the dizziness caused vomiting and a sever headache. I laid down for about an hour and feel a bit better but the headache has remained!! Hopefully this too will pass in a few more hours! Just thought you might want to know. If it gets worse I will contact my doctor. My husband has not had any other adverse reactions.
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| 70 | 2021-02-25 | anxiety |
Approximately 4 minutes post vaccine pt fainted in chair during obs. Pt transferred to gurney, RRT c...
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Approximately 4 minutes post vaccine pt fainted in chair during obs. Pt transferred to gurney, RRT called at 0840, they arrived 0846. Denies high BP. Vitals taken (0843)198/95, HR 96 o2 97% T-98.6. Pt comes to and reports hx of fainting with needles and nausea. No medical hx. Currently feels better and refuse to go to ER x3. V/s(0846) 195/95 HR 81 o2 97%. Husband by bedside fans pt. Continues to refuse ED service. (0855) 124/60 HR 81 o2 97% RRT left at 0852. Pt became anxious 0942 BP 173/81 HR 83 o2 97% pt wants to be released home AAO. D/C @ 0945 with husband.
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| 70 | 2021-02-25 | feeling abnormal |
slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous repo...
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slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events. .
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| 70 | 2021-02-25 | feeling abnormal |
Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for ...
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Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
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| 70 | 2021-02-26 | anxiety | Anxiety and tingling |
| 70 | 2021-02-26 | anxiety |
EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face withi...
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EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face within 15 min of receiving the COVID vaccine (Pfizer, lot #EN6202, expiration date 6/30/2021, dose 1). EMT approached client, asked how she was feeling, client reported feeling fine. At 1337 EMT took oxygen saturation 98% and pulse 96. EMT informed PHN of client's condition and possible language barrier. EMT stayed with client as PHN called over client's family member who was waiting outside. Family member used FaceTime to call client's daughter for help with translation. Per client's daughter, client suffers from anxiety, asthma, hypertension and hyperlipidemia. EMT took vital signs: blood pressure 140/Palpated, respiratory rate 24, oxygen saturation 97%, pulse 96. Client's list of medications: diltiazem, clopidogrel, atorvastatin, Montelukast, albuterol sulfate, incruise Ellipta, flucatisone propionate, vitamin D, famotidine, benzonatate, losartan, gabapentin, duloxetine, prednisone, and vitamin C. Client's daughter translated and reported that client felt anxious, warm, and had difficulty breathing similar to her asthma flares. PHN noted client's arm was warm to touch, face flushed, anxious movement as noted by repeated touching chest and face, no use of accessory muscles noted. At 1346, vital signs: oxygen saturation 95%, pulse 92, blood pressure 138/70, respiratory rate 24. At 1350, PHN offered client benadryl, client consented and took 2 capsules of benadryl (50mg dose) orally. At 1352, client moved to chair outside on patio in front of CWS in the shade as offered by PHN, gait steady and assisted by family member. At 1352, client signaled to family member that she felt better, PHN noted decreased flushing, posture relaxed with arms at sides while sitting in chair outside. At 1402, PHN advised client and family member to have client follow up with PCP within 24hrs or as soon as possible thereafter. At 1413, vital signs: oxygen saturation 96%, pulse, 84, blood pressure 140/90, respiratory rate 16. PHN noted client yawning, no redness noted in face, no longer warm to touch at 1415. At 1427 vital signs: oxygen saturation 97%, pulse 85, blood pressure 140/100, respiratory rate 16; PHN advised to call 911 if adverse reaction occurs. At 1430, client left, gait steady, with family member to the car. Family member drove.
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| 70 | 2021-02-27 | feeling abnormal |
Freezing cold to the point of shivering and teeth chattering - chills, headache, body ache, foggines...
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Freezing cold to the point of shivering and teeth chattering - chills, headache, body ache, fogginess, extreme fatigue. Tylenol every 6 hours. Cold packs on head and neck. All except headache went away by Friday, 2/26/2021.
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| 70 | 2021-02-28 | sensation of foreign body, nervousness |
nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she...
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nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she has a cough in her throat; swelling and soreness of her arm; swelling and soreness of her arm; Tightness in her jaw; Numbness in hand; difficulty swallowing; taste in her mouth; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in left arm on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization in a clinic. Medical history included ongoing underactive thyroid, cataract surgery on 14Oct2020 and on 28Oct2020, and cholesterol (abnormal). Concomitant medications included ongoing levothyroxine for underactive thyroid and ongoing rosuvastatin calcium for cholesterol. The patient experienced nervousness, slight swelling/tingling in lips, dizziness, like she has a cough in her throat, swelling and soreness of her arm, tightness in her jaw, numbness in hand on 26Jan2021. The patient also had difficulty swallowing, had taste in her mouth, and dry mouth in Jan2021. The patient on the line calling about the COVID-19 vaccine. She got the shot yesterday (26Jan2021) and was calling to report on the reaction that occurred. She initially stated she had slight swelling/tingling in lips, difficulty swallowing, numbness in hands, jaws became tight, and nervousness which she is still experiencing. She mentioned she took benadryl. She was wondering if she should go and get the second shot. The patient first experienced dizziness which lasted for a second and this occurred while waiting in the lobby for observation after getting the vaccine. Slight swelling and tingling in lips were noticed two minutes after the dizziness. It felt like a tingle sensation. She clarified she does not necessarily have difficulty swallowing. It was not so much she could not swallow, but it was like she has a cough in her throat. It feels like she could cough but would need to keep swallowing and drinking water. Once she got the shot it caused her to get a taste in her mouth. The feeling like a cough in her throat has gone away, but now she feels nervousness, dry mouth, and she still has that taste in her mouth from getting the shot. She had swelling and soreness of her arm, but she knew that was to be expected which started an hour after getting the vaccine. Tightness in her jaw was noticed an hour after getting the vaccine. The numbness in hand started at the same time as the tightness of her jaw. Her left hand is what went numb, and she had the vaccine administered in her left arm. The nervousness is getting better, but she felt very nervous. She also mentioned she has thyroid problems and is not sure if this has anything to do with it. She had this nervousness feeling 2 hours after getting the shot. Patient is scheduled to get the second vaccine on 18Feb2021. Benadryl has helped a lot. The patient has no additional vaccines administered on the same date and has no prior vaccination within four weeks. The events did not require emergency room and physician office visit. Vaccine was not administered in a military facility. The patient was recovering from events nervousness, slight swelling/tingling in lips, swelling and soreness of her arm, tightness in her jaw, and numbness in hand; recovered from dizziness on 26Jan2021; recovered from event "like she has a cough in her throat" on unspecified date; not yet recovered from event "taste in her mouth"; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-01 | confusional state |
Confusion, Myalgia, Fever, Diarrhea, Nausea Vomiting, ElevatedLiverEnzymes, Jaundice, ElevatedBunSCr...
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Confusion, Myalgia, Fever, Diarrhea, Nausea Vomiting, ElevatedLiverEnzymes, Jaundice, ElevatedBunSCr, , Continues to feel weak and following up with PCP. Reports had no health issues prior to her second vaccine dose. She reports had fever, joint pain and nausea with first dose. Patient reports receiving her first COVID vaccine 12-23-20 and developed nausea, joint pain and fever. She had her second dose on 01-11-21 and noted nausea,vomiting, weakness, become jaundiced and fevers that required hospitalization and developed autoimmune problems. She reports hepatitis and kidney problems and PCP following.
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| 70 | 2021-03-01 | disorientation |
Experienced Dizziness after the Pfizer vaccine. I waited 15 minutes on site and experience the dizzi...
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Experienced Dizziness after the Pfizer vaccine. I waited 15 minutes on site and experience the dizziness the entire time. I left after the 15 minutes and still had slight disorientation. After 30 minutes I fell normal.
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| 70 | 2021-03-01 | excessive sleepiness |
Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwar...
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Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwards for almost 12 hrs. Thereafter, symptoms gone other than fatigue and sore arm.
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| 70 | 2021-03-02 | feeling abnormal |
all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size...
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all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a "severe allergic reaction" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was "very red, like a tomato" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, "skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-02 | insomnia |
rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping;...
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rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events "headache, fever, chills, body ache, and 3 days with out sleeping" was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-03 | feeling abnormal | Foul smelling urine Feeling of fogginess Intermittent chills |
| 70 | 2021-03-03 | nervousness, anxiety |
severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wh...
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severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wheeze; she is also shaky; general malaise; heart attack; and last night she drank some water and choked on it then couldn't get her breath and; chest was hurting radiating to my arm down; fever; chills; exhausted/just felt very tired; her arm that was sore was the one where she had her injection; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration (on left arm) on 15Feb2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included asthma, sleep apnea, thyroid problem, prediabetes, cpap use, all from an unknown date. There were no concomitant medications. Patient reported her face is blood red. Last night her chest was hurting radiating to my arm down. It felt like someone was strangling her with water. She noticed my symptoms were what people experience after receiving the second dose. She had fever, chills, exhausted and just felt very tired after receiving the first dose. She still have trouble breathing. She had severe asthma. She was not breathing normally. When she put the mask on it's even harder to breath. She was worried. She thinks, she might have the coronavirus. Consumer says that she is still not feeling well after receiving her first dose of the Pfizer COVID-19 vaccine on February 15th. She says that the first day after getting it, she had pain in her arm, it was achy, it was not really painful enough to where she had to take Tylenol for it. She says yesterday on the second day she had fever, chills, tiredness, general malaise, and today she is not feeling well. Caller says she was having trouble breathing, and did a treatment with her nebulizer which she has because she has real bad asthma. She says her breathing is labored and she wheezes every once in a while. She says she would like to see if there is anything that she needs to do, because she works with children, and if she is coming down with the corona virus she doesn't want to be around them with it. She says that her breathing is problematic today. She says she doesn't think that she is having a severe reaction, she has no rash or those kind of symptoms. She says it seems to be just the asthma, and last night she drank some water and choked on it then couldn't get her breath and her chest hurt and she had pain down her arm and thought oh gosh she was having a heart attack.Caller says she has done no treatments other than the nebulizer treatment. No further details provided about the nebulizer treatment. Caller says the provider said no Tylenol right away, so she didn't take any yesterday with her fever, and she didn't have a thermometer to take her temperature, but her face was really hot and she was having chills, which usually means she has a fever. She says that her arm that was sore was the one where she had her injection. She says that never really was that bad, everyone said their arm had ached, and she has a high pain threshold so it never bothered her. Her wheezing and little trouble breathing was better, after she did some breathing treatments with the nebulizer, she is not breathing well but she is breathing better. She says she is also shaky and doesn't know if that is just nerves, or if this is also something going on. Caller says that it has been a while since she had blood work, which was the last time she went to see physician, but she doesn't know the results for what they found out. The outcome of the events Breathing difficult,wheeze was recovering, other events was unknown.
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| 70 | 2021-03-04 | feeling abnormal |
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by swea...
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Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea. Lasted from 8:15am til 11:30am. I called my care team at clinic they suggested that I call "911", but I did not call "911". My daughter who is a nurse came over to my house & stayed with me until 11:30am. On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
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| 70 | 2021-03-05 | anxiety | Tachycardia, anxiety, difficulty breathing. Cleared by medics. |
| 70 | 2021-03-07 | feeling abnormal |
Pfizer-BioNTech COVID 19 Vaccine EUA Fatigue the day after my vaccine. Felt like I was "in a fog"....
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Pfizer-BioNTech COVID 19 Vaccine EUA Fatigue the day after my vaccine. Felt like I was "in a fog". Went to bed at 8pm, coughed for an hour (not my asthma cough), chills, woke up at 8am Felt fine the 2nd day after my vaccine.
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| 70 | 2021-03-07 | insomnia |
Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't s...
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Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't sleep, fatigue, rash at injection site and down the arm and then several days post injection rash on thigh
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| 70 | 2021-03-07 | loss of personal independence in daily activities |
Since March 1, every day I have felt dizziness and some nausea throughout the day, when I get up out...
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Since March 1, every day I have felt dizziness and some nausea throughout the day, when I get up out of bed in the morning, bend down and come up when doing laundry, cleaning, kitchen work, dressing, exercise and other normal daily activities. I must keep my upper body and head upright, and avoid bending, in order to prevent this dizziness. As a result, I feel weak and uncomfortable, and fear doing normal movement and activity.
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| 70 | 2021-03-08 | excessive sleepiness |
At 6am I was awakened with chills, muscle aches. I took a Tylenol and went back to bed sleeping ano...
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At 6am I was awakened with chills, muscle aches. I took a Tylenol and went back to bed sleeping another 4 hours after already sleeping for 8 hours. I spent the remainder of the day with fatigue and sometimes muscle aches. I took one more Tylenol and the symptoms subsided by 6 pm that day.
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| 70 | 2021-03-08 | restlessness |
3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and aroun...
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3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and around injection area 3/7/21 Arm worsen with the bruising and redness 3/8/21 & 3/9/21 No improvement in arm Took Benadryl- no change
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| 70 | 2021-03-09 | feeling abnormal | Tiredness, mind fog, diarrhea |
| 70 | 2021-03-09 | nightmare |
5 nights having nightmares; waking with rapid heart rate; This is a spontaneous report from a non-co...
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5 nights having nightmares; waking with rapid heart rate; This is a spontaneous report from a non-contactable consumer (patient). A70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 30Jan2021, at 14:30 (age at vaccination: 70 years) as a single dose for COVID-19 immunisation. The patient medical history included IgA blood deficiency, hypothyroidism and allergy to horse serum. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included levothyroxine sodium (LEVOTHYROXIN) at 88ug daily, monascus purpureus (RED YEAST RICE), glucosamine hcl + msm (glucosamine hydrochloride;methylsulfonylmethane), calcium, fish oil, loratadine (CLARITIN), minerals nos, vitamins nos (ONE A DAY). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that during the 2 weeks after the first dose, the patient experienced 5 nights having nightmares and waking with rapid heart rate on 05Feb2021. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events 5 nights having nightmares and waking with rapid heart rate was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-09 | sleep disorder |
She received the vaccine, and went to bed at midnight and felt great all day long. She believes abo...
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She received the vaccine, and went to bed at midnight and felt great all day long. She believes about 5 minutes later started having chills. She has a weighted blanket and had that with 2 other blankets on her, and started shaking, and then her teeth started chattering and could not prevent them from banging together. She was afraid she was going to break a tooth. This lasted for almost an hour. She finally fell asleep and normally does not move when sleeping, and tossed and turned all night. She usually gets up a couple of times a night to use the bathroom, and did not get up until 6:00 Am, and when she tried to get up she was woozy, and was not able to walk due to feeling like she was going to fall over and almost fell in the bathroom but has grab bars that she was able to grab. She normally gets up at 4:00 Am, and got up at 8 after getting up at 6. She was not able to sit up and when she got up for the day was listing like a drunken sailor and not able to eat and managed to get some water down. She did take a Tylenol, and took her VS which were normal. She had tried to call her doctor but due to weakness was not able to. She was still uneasy from a deep sleep last night, but today she is feeling better but afraid of losing her balance. Her arm is still a little sore, but pretty good right now.
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| 70 | 2021-03-10 | feeling abnormal, depression |
Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, dep...
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Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, depression, lethargy, brain fog, nausea, diarrhea, pinched nerve between should blades, swelling in both hips
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| 70 | 2021-03-10 | feeling abnormal |
Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, n...
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Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, no appetite, brain fog, extreme fatigue, for 8 days or more. COPD so much worse that I had to use albuterol twice a day which I didn't use before lasting 2 weeks. No daily walk for 2 weeks because I couldn't balance properly. Sweats and chills not corresponding to temp fluctuation 2 weeks. Night sweats which I have never had before EVER. My scleritis kicked in really bad, worse than ever before. I still don't feel well 19 days later
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| 70 | 2021-03-10 | nervousness |
After client received her vaccine client stated she feels flushed and shaky. Vital signs obtained. ...
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After client received her vaccine client stated she feels flushed and shaky. Vital signs obtained. BP 126/83, HR 93, O2 Sat 99%.
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| 70 | 2021-03-13 | insomnia, anxiety |
12-14 days after my first dose of the Pfizer vaccine I experiences severe increase in what has been...
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12-14 days after my first dose of the Pfizer vaccine I experiences severe increase in what has been very mild tinnitus (from hearing loss) After the second dose (lot EN6200) on Feb 21, 2021 tinnitus became unmanageable causing insomnia, anxiety and blood pressure spike to 155/80. Was treated with Amlodipine --pressure came down but tinnitus not resolved.
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| 70 | 2021-03-14 | anxiety |
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor...
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syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-03-15 | sleep disorder |
Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, ...
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Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, and from my neck to entire head, I felt swollen. Got home, collapsed in chair, had a faint sign of difficulty breathing, but not bad. Still felt swollen. Disappeared about 2 hours at home. Nausea getting worse. Feeling chilled, feverish, and dizzy. Unable to sleep that night, so nauseated I couldn?t even swallow water without wanting to puke. Shot on Tuesday, didn?t feel much better till Friday. Ok now.
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| 70 | 2021-03-15 | sleep disorder |
2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed a...
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2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed at home. Monday (3-15-21) did a few errands and had constant diarrhia By 7:00 pm did not feel well and went to bed. Had nothing to eat all day, and by 8:00pm was vomiting fluids only and more diarrhia. slept fitfully with muscle cramps, shivers, then seats-cold and hot throughout the night. Finally awake and out of bed my 11:00 am
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| 70 | 2021-03-15 | sleep disorder |
Pain and warmth surrounding needle at time of FIRST injection. Subsequent: Fell soundly asleep 1 ho...
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Pain and warmth surrounding needle at time of FIRST injection. Subsequent: Fell soundly asleep 1 hour after shot for 8 hours. (4pm-midnite), woke for 3 hrs, slept again 'til noon. Each day for 3 weeks fell asleep 2ce/day (very unusual) 8 or 4 hours at a time, never being awake for more than 4-5 hours. (still occurring, but lessening a bit).
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| 70 | 2021-03-16 | anxiety |
Palpitations for 10 minutes. Forgot to take HTN meds and is feeling anxious. Denies any HA, dizzin...
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Palpitations for 10 minutes. Forgot to take HTN meds and is feeling anxious. Denies any HA, dizziness, CP, or SOB, States she'll go home and take meds. BP 202/110. Doctor consulted and deemed her fit to be released.
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| 70 | 2021-03-16 | excessive sleepiness |
Since my second shot on February 19, I have started sleeping more and more. I am sleeping from 14 t...
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Since my second shot on February 19, I have started sleeping more and more. I am sleeping from 14 to 18 hours a day and could sleep more if I didn't force myself to get up. No other symptoms just extreme fatigue
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| 70 | 2021-03-16 | insomnia |
12 hours after shot, shaking and cold. Leg cramps. Little sleep. However, I went throughout my day ...
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12 hours after shot, shaking and cold. Leg cramps. Little sleep. However, I went throughout my day with no issues and symptoms ended around 6pm the next day.
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| 70 | 2021-03-16 | mental impairment, feeling abnormal, nightmare, nervousness |
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/p...
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She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
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| 70 | 2021-03-16 | sleep disorder |
per patient: I was awakened at 0145 hours on 11 March with tingling in the RIGHT SIDE of my FACE an...
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per patient: I was awakened at 0145 hours on 11 March with tingling in the RIGHT SIDE of my FACE and JAW. The Right Side of my TONGUE and LOWER JAW along the GUM LINE were EDEMATOUS and worsening as was my Right Cheek. I knew immediately what was occurring as I have a HISTORY of ANAPHYLACTIC Response to BEE STINGS and MUSHROOMS. I have EPI PENS and BENADRYL with me 24/7. I am also a Registered Nurse. I immediately took 50mg of BENADRYL Orally at 0150 hours, and continued to monitor the progression of my symptoms and my vital signs. By 0330 the tingling in my face and jaw abated. The Edema began to lessen at approximately 0610. I DID NOT have to use one of my EPI PENS. I DID NOT make an Emergency Visit to the ER, nor to my physician. (pt also noted she attempted to send in four (4 ) VAERS Reporting Forms to know avail. I kept receiving "ERROR" COULD NOT SEND" messages and she called the VAERS telephone line 9 times, and left messages with no response).
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| 70 | 2021-03-18 | insomnia, anxiety |
have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm ...
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have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm started hurting; Very tired; Very thirsty; One of legs got weak; achy; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration, in the right arm on 10Feb2021, 12:15 at a single dose for covid-19 immunization. The patient's medical history included ongoing Hashimoto's Hypothyroidism from 2000 (had it at least five years before a diagnosis), allergies year-round, depression, pneumonia, wheezing, calcium deficiency from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for Hashimoto's Hypothyroidism from an unspecified start date and ongoing; bupropion hcl (BUPROPION HCL) taken for depression from an unspecified start date and ongoing; loratadine (LORATADINE) taken for allergies year round from an unspecified start date and ongoing; aspartate calcium, aspartate zinc, calcium ascorbate, glucosamine sulfate, magnesium aspartate, manganese aspartate (BONE STRENGTH) taken for calcium from an unspecified start date and ongoing; carbinoxamine maleate (OMEGA 100), colecalciferol (VITAMIN D3), chondroitin sulfate, collagen, glucosamine (COLAGEN) taken for an unspecified indications from an unspecified start dates and ongoing. When she was older the patient was given the high dose Flu Vaccine and had this reaction where her arm was red from shoulder down to elbow. After that she told them not to give her the high dose Flu Vaccine. She gets the regular Flu Vaccine. She assumes it occurred year turned 65, but was not sure. She does not have a lot/exp/NDC to provide. The patient experienced arm started hurting and very tired (around 7:00-7:30), very thirsty (had to drink three tall glasses of water back to back, reported she was never that thirsty), one of legs got weak (for a brief moment one of her legs was very weak and noticed while walking from the living room to the bed room) and achy on 10Feb2021. It was reported that the patient took a bath with Epsom Salt and it id not help. She got in bed by 8PM. Normally she goes to bed around 9:30-10 PM, but she was very tired. She then followed up and stated she went to sleep after the news about 10:20. Then at 4:45 AM she woke up because her eyes were very dry. Stated she has a humidifier in the apartment and usually has no trouble with her eyes, but they were very dry. She also noticed her ribs were hurting and it was noticeable on 11Feb2021. She was also more achy, but it the ribs hurting did not last real long. Then she noticed she was wheezing (11Feb2021). She knows she was wheezing because she has had pneumonia in the past and had wheezing then. The wheezing she had after the vaccine was not real bad. It stopped after about 10-15 minutes or so. She had laid down in bed for a while then got up around 5:30 AM. She felt better around then, but it took until like around 8AM before she felt fully okay as her arm was still aching. The outcome of the event arm started hurting and achy was recovered on 12Feb2021; eyes dry, ribs hurting and wheezing recovered on 11Feb2021; thirst and muscular weakness recovered on 10Feb2021, and unknown outcome for the remaining events.
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| 70 | 2021-03-19 | feeling abnormal |
Noticing that I have a very low high pitch sound in my right ear with some fuzziiness that I sincere...
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Noticing that I have a very low high pitch sound in my right ear with some fuzziiness that I sincerely believe started around the time of the second dose.
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| 70 | 2021-03-19 | loss of personal independence in daily activities |
Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed ....
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Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed . Please help me . I have taken Tylenol
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| 70 | 2021-03-20 | feeling abnormal |
Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Ton...
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Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Tongue raw and sore and loss of taste. Very tired and achy. Low grade fever and chills. Unable to put two sentences together. Fill like my head is full of fog.
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| 70 | 2021-03-20 | feeling abnormal |
8 days after receiving 1st vaccination Lightheaded, dizzy , weakness in legs Feels like Cotton i...
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8 days after receiving 1st vaccination Lightheaded, dizzy , weakness in legs Feels like Cotton in my brain Fog brain Lethargic, malaise
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| 70 | 2021-03-21 | loss of personal independence in daily activities |
The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I bega...
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The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I began having extreme fatigue and muscle aches throughout my entire body. I felt inflamed. The fatigue impaired my ability to walk and do normal activities. I mostly wanted to sleep. At first I did not associate the symptoms with the vaccine, but then realized it was probably associated. The fatigue and muscle aches lasted about 7 or 10 days.
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| 70 | 2021-03-23 | agitation, confusional state |
Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5...
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Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5 minutes and were followed by an overwhelming weakness, confusion, later also by abdominal cramps, some urinary urgency- all gradually improved over 30-40 minutes. I felt later agitated, had dry mouth, headache- improved after drinking 8-10 cups of water. I did not seek help. I stayed in the shot area in a large tent.
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| 70 | 2021-03-25 | sleep disorder |
I had my 2nd Pfizer Covid shot on 3/23/21 at 10:20 am. By 11:55 pm on that same day I began to feel ...
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I had my 2nd Pfizer Covid shot on 3/23/21 at 10:20 am. By 11:55 pm on that same day I began to feel chilled. By 2:30 am on 3/24/21 I had a temperature of 101.2 f. and took 1 Tylenol 500 mg.. I slept very poorly. By 11 am on 3/24/21, I still had a 100 degree fever and chills with a slight headache. No left arm muscle ache however. I took another Tylenol 500 mg at that time. By 5 pm on 3/24/21, my fever went up to 100.2 and I took another 500 mg Tylenol. I went to bed at 9 am, slept poorly but woke up at 7 am with a normal temperature of 98.
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| 70 | 2021-03-27 | disorientation |
Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over ...
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Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over 8 hours Muscle & joint ache Headache...at times like migraine with light sensitivity VERY TIRED Loss of appetite Disorientation Off balance
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| 70 | 2021-03-28 | excessive sleepiness |
Became extremely fatigued starting approximately 12 hours after receiving 2nd dose of Pfizer Covid v...
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Became extremely fatigued starting approximately 12 hours after receiving 2nd dose of Pfizer Covid vaccine. Fatigue lasted 48 hours, sleeping nearly 18 hours each day. Experienced a mild headache approximately. 12 hours after 2nd dose of Pfizer Covid vaccine. I took Tylenol 325 mg, headache resolved 4 hours later.
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| 70 | 2021-03-29 | feeling abnormal |
does not feel good; hives on her neck that itched; This is a spontaneous report from a contactable c...
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does not feel good; hives on her neck that itched; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated right after she had the shot she had just a couple hives on her neck that itched but they went right away. She stated she took a Benadryl the night before so she thinks this is why it went away. She did not feel good for probably two weeks. The outcome of the event hives on her neck that itched was recovered and the outcome of the other event was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.
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| 70 | 2021-03-29 | panic attack |
Several minutes after injection, patient reported feeling dizzy and was developing a headache. She...
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Several minutes after injection, patient reported feeling dizzy and was developing a headache. She was afraid she was going to faint. The patient was moved to a private space where I monitored her vitals for one half an hour. Her BP's were 130's to 140's over 70's. HR was 100's. The patient was provided a snack and hydration. Pharmacist recommended 25 mg of Benadryl as a precautionary measure. The patients symptoms improved rapidly and it appeared that the patient was recovering from a panic attach. After chatting for 30 minutes, the patient was smiling, laughing, with stable vital signs. Patient was discharged with agreement from charge pharmacist.
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| 70 | 2021-03-30 | anxiety |
Follow 1st injection of Pfizer on 3/12/2021 she developed difficulty swallowing while on the drive h...
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Follow 1st injection of Pfizer on 3/12/2021 she developed difficulty swallowing while on the drive home. She could only swallow by forcing it. This was accompanied by a feeling of anxiety. The sensation persisted over a few minutes, then improved. Her throat hurt to swallow for a few hours, then symptoms resolved. She was eval by her physician on 3/23/2021.
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| 70 | 2021-03-30 | confusional state |
Three hours post vaccination, I experienced for 30 minutes visual hallucinations left eye, the lower...
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Three hours post vaccination, I experienced for 30 minutes visual hallucinations left eye, the lower half the visual field (as though I had rubbed my eye hard.; I had photophobia as well; I also had left sided facial numbness that lasted 30minutes.; My tinnitus became much louder and that is continuing.; felt confused; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 11Mar2021 12:00 as SINGLE DOSE for covid-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. Medical history included fibromyalgia, chronic fatigue syndrome, non-specific autoimmune disorder, allergies to Sulfa, Penicillin-light rash each. Concomitant medications included fenofibrate and tizanidine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. Three hours post vaccination, patient experienced for 30 minutes visual hallucinations left eye, the lower half the visual field as though she had rubbed eye hard. Patient had photophobia as well. She also had left sided facial numbness that lasted 30 minutes. She noticed no drooping of eye lid or mouth. Her tinnitus became much louder and that is continuing. She felt confused for the rest of the day of vaccination. The events onset date were reported as 11Mar2021 03:00 PM. The adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. Patient didn't received treatment for the events. The outcome of events was recovering. Patient have no Covid prior vaccination nor tested Covid post vaccination.
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| 70 | 2021-03-30 | feeling abnormal |
Patient presented healthy and in good spirits at the time of administration. Was counseled on typica...
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Patient presented healthy and in good spirits at the time of administration. Was counseled on typical side effects of the vaccine and that the second dose can have more pronounced side effects because we already have built up an initial defense against the first exposure. Patient was understanding and aware of what to look for as well as courses of symptom management. Immediately after administration, the patient reports feeling hot and "funny." Upon visual examination she appeared flush with no visible signs of sweating. After monitoring her for 10 minutes she reported feeling better but still funny and hot. During this time we learned that she has a history of hypertension and was treating with daily verapamil and Telmisartan, and assures us that she hasn't missed any recent doses. At this point, her blood pressure was taken and noticeable sweat stains were evident around her axilla. Her first blood pressure reading, using an automated electronic sphygmomanometer, came up 249/119 with a heart rate of 138bpm. A second reading was taken after more than 5 minutes had elapsed and the patient was given water for complaints of dry mouth; this came up 245/110 130bpm. At this time we asked the patient if she wanted us to call for EMS to be transported to the hospital. She declined stating she was feeling a bit better, but now she was feeling congested and chilly. We continued to monitor her and build rapport to ensure she was keeping alert and responsive. Around 14:40 after speaking with her for several minutes, we found that she may have been hesitant to seek medical attention because she didn't want to be the first patient needing to be taken by EMS, and we were able to explain that even if she was experiencing the same symptoms prior to vaccination, we would have recommended EMS assistance because she was experiencing a hypertensive emergency. she accepted since she was experiencing a hypertensive emergency. She then requested that we call for EMS and a call was placed at 14:45. By 15:00 EMS arrived and took her to the nearest facility.
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| 70 | 2021-03-30 | sleep disorder |
So-full blown flu attack last night around 9pm Body aches; So-full blown flu attack last night aroun...
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So-full blown flu attack last night around 9pm Body aches; So-full blown flu attack last night around 9pm Body aches; headache; chills; exhaustion; I woke up around midnight and was awake for hours; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Feb2021 10:00 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation. The reporter stated that so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion on 15Feb2021 21:00. I took extra strength Tylenol and went right to bed. I woke up around midnight and was awake for hours! I took 2 more Tylenol and eventually went back to sleep. I feel much better this morning not 100%. I took an ALEVE. Therapeutic measures were taken as a result of so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion and I woke up around midnight and was awake for hours and included treatment with Tylenol and ALEVE. The outcome of the event was reported as recovering. Information on the lot/batch number has been requested.
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| 70 | 2021-03-31 | impaired work ability |
I have been itching all over my body for one week now. It is not getting any better. I have welts ...
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I have been itching all over my body for one week now. It is not getting any better. I have welts all over even in myhead. I cannot go to work or do anything else.
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| 70 | 2021-03-31 | nightmare, sleep disorder |
The pain in my right that is affected with CRPS (COMPLEX REGIONAL PAIN SYNDROME ) became much mor pa...
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The pain in my right that is affected with CRPS (COMPLEX REGIONAL PAIN SYNDROME ) became much mor painful than it always is. I have made some gains in getting relief from an Acupuncturist and a Neurosomatic Therapist. The pain made me feel like I had regressed to years ago. Also, very oddly, my sleep was affected. I had a lot of trouble sleeping for about a week and had very violent nightmares
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| 70 | 2021-04-03 | anxiety |
Patient had loose stools while in bathroom with caregiver and very anxious. Patient given snacks and...
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Patient had loose stools while in bathroom with caregiver and very anxious. Patient given snacks and water and released to family. 114/65, 82, 16, 98% RA
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| 70 | 2021-04-04 | sleep disorder, impaired work ability |
headache, nausea, weakness, extremely sore muscles to the point of not being able to lift objects o...
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headache, nausea, weakness, extremely sore muscles to the point of not being able to lift objects or walk steady for 4 days. In bed the 4th day, unable to go to work & slept almost 24 hrs. due to feeling totally exhausted
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| 70 | 2021-04-05 | feeling abnormal |
This was my 2nd covid vaccine. I received my first one on March 2, 2021 and was extremely tired and...
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This was my 2nd covid vaccine. I received my first one on March 2, 2021 and was extremely tired and fatigued up until the day I went to receive the 2nd vaccine. I received the vaccine around 12:45pm on 3/23/21, around 6:30pm. I started to get an intense headache, fatigue, mild arm soreness, slight chills and nausea.. Chills and nausea subsided next day., but the headache has persisted since Mar 23, 2021 until today April 6, 2021. I have had to take Advils 400mg to 600mg per day to help eleviate the headache. It has helped but the headache returns. It is a little better today, April 6th but I did take 600mg advil today. Along with the headache is fatigue and tiredness, which has required daily naps, and not feeling refreshed after the naps. Also a feeling in my head as "brain fog". I did not see my doctor nor did I alert her. Today it has been 2 wks since the 2nd vaccine, I am just starting to feel somewhat better , but hope the headache does not return.
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| 70 | 2021-04-06 | disorientation |
dizzy, heart palpitations, disoriented, then a day later flu, sore throat, swollen glands, diaahri...
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dizzy, heart palpitations, disoriented, then a day later flu, sore throat, swollen glands, diaahria, don't know temp
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| 70 | 2021-04-07 | anxiety |
Rapid heartbeat; Anxiety; Felt hot/heating up; This is a spontaneous report from contactable consume...
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Rapid heartbeat; Anxiety; Felt hot/heating up; This is a spontaneous report from contactable consumer (patient reported herself) via sponsored program. A 70-year-old non-pregnant female patient received first dose of BNT162B2 (COVID-19 Vaccine, Pfizer, Formulation: Solution for injection, Lot number: EN6200) via an unspecified route of administration to her right arm on 17Feb2021 01:30 PM at single dose for Covid-19 immunization. Facility type vaccine: Hospital. The patient's medical history included dental anesthesia. Known allergies included "she had a similar reaction to dental anesthesia - mepivacaine/carbocaine and had to switch to septocaine which had less central nervous system impact". Concomitant medications (other medications in two weeks) included levothyroxine sodium (SYNTHROID) and clopidogrel bisulfate (PLAVIX). On 17Feb2021 01:30 PM, the patient felt fine for the first five minutes after first shot, but then got rapid heartbeat, anxiety and felt hot. The nurse checked for rashes, breathing, etc. and said she was not having an anaphylactic reaction. Her symptoms subsided after 5-10 minutes and was sent home and felt fine. She wanted to ask whether she should go ahead and get second shot in 3 weeks. It was reported that, "had first shot. She had rapid heartbeat and heating up. Inquired if she should take her second dose. Transferred to hospital queue. Would fax to company. She did not receive any treatment in response to the events. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-04-07 | mental impairment |
Trigeminal neuralgia 1 day recurrence post vaccine. Had not had this for 6 years (was post viral) W...
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Trigeminal neuralgia 1 day recurrence post vaccine. Had not had this for 6 years (was post viral) Word groping for 1-2 hours day after 2 nd vaccineCould not say what I was trying to. Same as post virus occurrence of 6 years ago.
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| 70 | 2021-04-08 | disorientation |
Left arm pain, nausea, dizziness, upset stomach, disorientation, headache. Lasting three days. Still...
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Left arm pain, nausea, dizziness, upset stomach, disorientation, headache. Lasting three days. Still lightly dizzy - to date 4/9/2021
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| 70 | 2021-04-09 | incoherent, excessive sleepiness |
Pt reports that she got the covid vaccine. Pt reports extreme fatigue- states that she got the vacci...
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Pt reports that she got the covid vaccine. Pt reports extreme fatigue- states that she got the vaccine on 4/8/21 went to sleep on same day Thursday night starting at 8pm until Saturday morning at 6:55am. pt reports that she does not remember waking up to use the bathroom. pt reports that her daughter called her on Friday but does not remember having that conversation with daughter. reports that her daughter reported that her speech was incoherent and told daughter that she wants to sleep.
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| 70 | 2021-04-09 | insomnia, excessive sleepiness |
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had dia...
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Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.
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| 70 | 2021-04-09 | irritability, feeling abnormal, confusional state, anxiety |
flu-like symptoms for five days after shot, then developed severe vertigo on or around 3/24/21, incl...
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flu-like symptoms for five days after shot, then developed severe vertigo on or around 3/24/21, including nausea, lack of balance, mental fog, feelings of dissociation, severe anxiety, feeling like floating, feeling like floor tilting, inability to stand without feeling I would fall, headache on and off, tired, woozy, irritable, rapid heartbeat. Mental confusion still exists as does dizziness. Dizziness not as severe, save when I move my head rapidly, or stand up, but mental confusion (brain fog) still a problem.
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| 70 | 2021-04-11 | feeling abnormal |
Very sore throat on right side, felt as if gland was swollen and/or Eustachian tube was swollen begi...
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Very sore throat on right side, felt as if gland was swollen and/or Eustachian tube was swollen beginning March 14. Hives beginning March 17 to March 30. Hives spread to arms and legs and some on face and chest. Occasional blister like bumps and sticking sensation. Hives could be calmed with antihistamine. Beginning March 31, hives were intermittent for a week. Primary care physician contacted on April 9 who advised me to not get the second shot on April 10.
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| 70 | 2021-04-14 | feeling abnormal |
About five minutes after I received the shot, I started feeling faint. I also felt like my nasal pa...
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About five minutes after I received the shot, I started feeling faint. I also felt like my nasal passages, throat, and bronchial tube were swelling up . Taking a decongestant helped that. For a couple days following the shot, I had brain fog.
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| 70 | 2021-04-15 | feeling abnormal |
Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while drivin...
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Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while driving. Nausea passed in 2-3 hours and I felt fine. The next day I felt tired, foggy brain, and dizzy. Assumed it was from the shot. Side effects continued/worsened. 4/6/21 I saw my Dr. She checked me over, labs. found nothing wrong with me. Likely side effects from Pfizer. Unlikely that they would last two weeks. Rx Meclizine for dizziness, which didn't really help. Now it's Day 15. Tired and brain fog are gone. I don't feel as dizzy. BUT, when I try to drive, I feel QUITE dizzy with blurred vision. This side effect persists and clearly effects my quality of life.
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| 70 | 2021-04-16 | feeling abnormal |
2:30 pm Patient complaint of foggy head, headache, flushed feeling, sweaty, dry mouth, jaw felt "wei...
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2:30 pm Patient complaint of foggy head, headache, flushed feeling, sweaty, dry mouth, jaw felt "weird", 2:30 pm BP 150/76, pulse ox 100%, pulse 76 2:55 pm BP 166/104 pulse Ox 99%, pulse 76 and complaint of feeling short of breath. No improvement of symptoms, 911 was called
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| 70 | 2021-04-18 | sleep disorder |
On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed...
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On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed away the night of her second dose of her Pfizer covid vaccine. He states that she complained of arm pain at the injection site that evening (4/14/21) and went to bed around 9:30pm because the pain was excruciating. He said around 2:00am, she woke up stating she couldn't breathe. This has happened before, so she went and sat up in the living room which helped her last time. For whatever reason, she then went into her bedroom where he said she fell out. He noticed foam coming from her mouth and called 911. EMS was unable to revive her. She passed away at home.
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| 70 | 2021-04-19 | sleep disorder |
On the day after vaccination I had a rash on my right arm below the injection site. This subsided w...
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On the day after vaccination I had a rash on my right arm below the injection site. This subsided within 24 hours. However, a few days later I started having patches of itchy rash on different areas of my upper torso, neck, arms. This subsides after I apply hydrocortisone cream. These occurrences were on an almost daily basis and usually at night when I would be woken up by the itchiness. After i apply hydrocortisone cream and take a Clariten, the itchiness subsides. On the night of April 18 the rashes and hives covered the abdomen and then extended to my chin, groin area and upper thigh near the groin area. Again it subsided after a while with hydrocortisone cream and Clariten. My primary care had me schedule an appointment with a dermatologists but I really think it is an immunologist I need to see. I am concerned that the mRNA is still active in my system and still directing my body to produce spike protein which is binding to my vascular endothelial cells and causing the rashes and hives.
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| 70 | 2021-04-21 | sleep disorder |
At 6PM suddenly experienced excruciating pain in my hands. Felt like they had been plunged into an ...
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At 6PM suddenly experienced excruciating pain in my hands. Felt like they had been plunged into an acid bath OR hands being attacked by a million needles. Could not bare hands to be touched and I could not touch ANYTHING with my hands. Could not sleep all night - had to keep hands away from sheets and in the air. In AM took tylenol every 6 hours. After 24 hrs very slight improvement still could not bare hands to be touched. After 48 hours still painful but bearable. Gradual improvement daily. After 7 days still pain in my index fingers. 8th day I could touch index fingers. Today still slight tingling on top of hands. Minimal.
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| 70 | 2021-04-22 | insomnia, feeling abnormal |
About 30 minutes after I received the second shot in my right arm, I started feeling different. I t...
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About 30 minutes after I received the second shot in my right arm, I started feeling different. I thought it was normal side effects, but it wasn't like the first Covid shot. After a couple days I was in pain around my right side of my neck, my right jaw, right ear, and right eye socket. Also pain on the right side of my head. After a week I decided to go to Urgent Care, where I was told it was an allergy, or maybe I had a bad tooth. I was told it was not from the Covid shot. So I took Claridin for a couple days with no relief of pain. Since the pain was not getting better and was keeping me awake I decided to go the the ER. The doctor there said it was shingles since I had a couple bllisters on my right jaw. I was told again it was not from the Covid shot. I didn't believe any of this. Just wanted to document this.
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| 70 | 2021-04-23 | excessive sleepiness, depressed mood |
her head was hurting also/headache; violently throwing up; diarrhea; muscle cramps/the muscles in le...
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her head was hurting also/headache; violently throwing up; diarrhea; muscle cramps/the muscles in legs she had crapping and shivering; muscle cramps/the muscles in legs she had crapping and shivering; felt a little tired; her voice is still raspy from the amount of acid; she was able to calm her stomach down after this; sickest; she thought she came down with a virus; she slept most of the next day after taking the Zofran; she had quivering in muscles of her legs; feels little run down but it was not too bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via unspecified route of administration in left arm on 09Feb2021, at 14:45 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient medical history and family medical history relevant to adverse event was none. The patient concomitant medication was not reported. The patient relevant tests were none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Additional vaccines administered on same date of the pfizer suspect was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient reported that she had the first dose on 09Feb2021 at about 14: 45pm. The next day, on 10Feb2021, she went to work but felt a little tired. That night about 22:00 she started violently throwing up, had diarrhea and had in the muscles in legs she had crapping and shivering on 10Feb2021. The diarrhea ended about the same time the vomiting stopped. It was so bad there was several time she didn't make to the restroom. She had quivering in muscles of her legs on an unknown date in Feb2021. The caller remarks that her voice was still raspy from the amount of acid. It was so bad she thought she came down with a virus because she thought it was too long after the vaccine. It was severe enough she called the doctor who gave her Zofran for the vomiting, she was able to calm her stomach down after this on an unknown date in Feb2021. If she hadn't she would have gone to the emergency room. She caller stated that she slept most of the next day after taking the Zofran. She could take 3 a day and then remarks she took at least 3 during the day on Thursday. Her second dose was scheduled on 02Mar2021, but she was not 100% sure she want to put her body back through that, it was bad, even the doctor said she may need to go get fluids at the emergency room. She doesn't want the virus but that was pretty brutal, probably the sickest she has ever been and she was not a sickly person. She stated she will definitely take a couple days off after the second dose if she does take it. She stated she has had all of the vaccines and has never had a reaction to any of them and this was pretty scary. She stated she will consult her healthcare provider, they may give her something to take before the vaccine to alleviate the symptoms. The caller asked, are these normal symptoms or was this a fluke. She stated she has heard the symptoms are worse after the second and asked if that is true. Later in the report the caller notes her head was hurting also on 11Feb2021. She had tried to refrain from taking Advil but did finally take some, she couldn't take the headache anymore. The patient feels little run down but it was not too bad. The outcome of the event muscle cramps/the muscles in legs she had crapping and shivering, violently throwing up and diarrhea was recovered on 11Feb2021 at 08:00, her head was hurting also recovered on 11Feb2021; felt a little tired, she was able to calm her stomach down after this was recovering; her voice is still raspy from the amount of acid was not recovered; sickest, she thought she came down with a virus, she slept most of the next day after taking the Zofran, she had quivering in muscles of her legs and feels little run down but it was not too bad was unknown
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| 70 | 2021-04-24 | insomnia |
vomiting; Diarrhea; really painful in stomach; couldn't sleep; nausea; headaches; fever; perspiring;...
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vomiting; Diarrhea; really painful in stomach; couldn't sleep; nausea; headaches; fever; perspiring; chills; flu-like symptoms; weakness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Mar2021 12:30 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included migraine, acne, high blood pressure, thyroid disorder, anxiety, ulcers and blood potassium decreased. Concomitant medications included topiramate taken for migraine, she began taking years ago and doesn't remember, she did not take this medication last night because she was afraid she might throw it up; doxycycline taken for acne from 2018 (began taking maybe about three years ago); ramipril taken for high blood pressure, began taking ages ago, forever, have been taking for a long, long time; levothyroxine taken for thyroid disorder from 2020 (began taking fairly recently, about a year ago); sertraline taken for anxiety, began taking a long time ago, a long time ago, years; metoprolol, heart doctor prescribed it, not quite sure about indication, from 2020 (began taking about 6 months ago); omeprazole taken for ulcers from 2006 (began taking a long time ago, again, that was a long time ago, maybe 15 years); potassium taken for potassium low from 2018 (three years ago). Patient stated she had several medications that she takes daily. Reported she hasn't taken any of her medications today or yesterday (as of 06Apr2021) because she was afraid she would vomit them up. No other vaccines were administered on same Date or within 4 weeks. Patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 30Mar2021 and she had been experiencing some "flu-like symptoms" including: vomiting, diarrhea, chills and weakness. Flu-like symptoms started from 30Mar2021. Patient reported vomiting and diarrhea, stated it really felt like the flu. Patient has had headaches, chills, fever. Vomiting: patient stated she vomited up so much that she thought she was starting to feel a bit better, patient doesn't think there is anything left in her. Reported she started to get a headache. Patient was concerned last night, because at first she just had the chills and headache, but then started to really feel flu like. Flu like symptoms: reported perspiring, vomiting and diarrhea and it was really painful in her stomach. As soon as patient could get rid of the bile and nausea in stomach, she felt a little bit better. Patient reported she was very weak. She had the flu a couple of years ago and it felt exactly like this. Patient reported she had chills and a headache and nausea. Reported the chills and headache began the same day she received Pfizer Covid Vaccine dose one on 30Mar2021. Vomiting/diarrhea: These symptoms began yesterday (05Apr2021), all day and all night. May have had a little the day before. Patient reported she was scared last night because she couldn't stop vomiting. Headache: reported the headache came right away, the same day caller received the Pfizer Covid Vaccine, later on that evening (30Mar2021). Fever: reported being really sweaty and having chills, but didn't take temperature. Patient could tell she had fever because she was shivering. This began the same day she received Pfizer Covid Vaccine (30Mar2021). Really painful in stomach: This began yesterday (05Apr2021), all day and all last night. Nausea: this began yesterday (05Apr2021), reported she was very nauseous, extremely nauseous, patient couldn't sleep and just wanted to get rid of the nausea. The patient would like to know if these are side effects associated with the Pfizer COVID-19 vaccine since she read most symptoms go away within a few days and it had now been a week since she received her first dose. The adverse events didn't result in emergency room or physician office. Stated she would be receiving another dose of the Pfizer Covid Vaccine on 20Apr2021. Relevant Tests were none. Outcome of events was recovering, patient reported she was feeling a little better now than she was yesterday, she was feeling a little better now, not 100%, a little nauseous. The report is non-serious. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-04-24 | memory impairment, feeling abnormal |
electric shocks on the neck and skull and above the ear and then where the bone was below the ear; h...
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electric shocks on the neck and skull and above the ear and then where the bone was below the ear; having pain shooting in her head down her right arm; having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) at the age of 70-years, via an unspecified route of administration in arm right on 15Mar2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 infection from Nov2020 to an unspecified date; seasonal bronchitis which comes with laryngitis almost every time. Concomitant medications included methylprednisolone from 05Apr2021 and ongoing; tramadol. Patient received her first injection of the vaccine and then 10 days later, she started experiencing electric shocks on the neck and skull and above the ear and then where the bone was below the ear, was on her right side, which was the same side where she received the vaccine. On unspecified date, the patient also experienced having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand. The patient underwent lab tests and procedures, which included on 02Apr2021, flu test was negative, COVID-19 virus test was negative. Outcome of the event electric shocks on the neck and skull and above the ear and then where the bone was below the ear was recovering/resolving while of remain was unknown. No follow up attempts are needed. No further information expected.
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| 70 | 2021-04-26 | hallucination |
pain at injection site, fatigue, SEVERE HALLUCINATIONS from late evening day of shot to late morning...
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pain at injection site, fatigue, SEVERE HALLUCINATIONS from late evening day of shot to late morning day after shot. No prior hallucination ever.
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| 70 | 2021-04-27 | confusional state |
Patient received covid vaccine. She was near the end of her 30 min wait time due to nausea after th...
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Patient received covid vaccine. She was near the end of her 30 min wait time due to nausea after the 1st injection. Patient was reporting nausea. Patient began to feel lightheaded and felt like she was going to pass out. Cart was obtained. Patient passed out and was unresponsive. EMS was called. Patient lifted to cart. Patient not arousing to her name being called. Sternal rub performed to arouse her. BP 117/89 HR 88 O2 Sat 100. Patient awake but confused. Reporting headache and chest pain. BP 125/92 HR 84 EMS arrived. Patient taken to ER.
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| 70 | 2021-04-27 | feeling abnormal |
After a couple of days my head felt strange, like the beginning of a cold. The third day I started c...
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After a couple of days my head felt strange, like the beginning of a cold. The third day I started coughing, then for three days just totally miserable, coughing uncontrollably and sinuses filled. I was able to blow my nose and was coughing up phlegm, lots of it. I drank lots of water, took guaifenesin cough syrup and phenylephrine HCl sinus tablets. After a week it lessened, to where now 2 1/2 weeks after it started I have coughing spells just three or four times a day. I also have a very small sore spot on my right side where the front and back ribs meet, which I believe is a pulled muscle from coughing. I did not take my temperature but I don?t believe I had a fever. I felt it was a severe cold, but I was encouraged to report it since it was right after the second vaccination.
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| 70 | 2021-04-27 | feeling abnormal |
feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard a...
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feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard and hot beside the site of injection; woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site; General malaise; Nausea; Headache; This is a spontaneous report from a contactable consumer (Patient). This 70-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZERBIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262; Expiry date: unknown) via intramuscular route, administered in right arm as a single dose (at the age of 70-year-old) for COVID-19 immunization. The patients past medical history included Cesarean section (Had 3 of them. Caller said that did well with anesthesia and had no reactions), cataract removal (First was on 24Nov2020 and the second 01Dec2020. Caller said that did well with anesthesia and had no reactions), Hysterectomy (Caller said that did well with anesthesia and had no reactions), Foot surgery (Caller said that did well with anesthesia and had no reactions), cataract removal on 01Dec2020. The patient was allergic to Penicillin and tetracycline. The patient allergic to Keflex and had a rash. Tetracycline she had in her 30's got a shooting pain in her left arm and got another shooting pain in her left arm when she took tetracycline again. She had no other allergies aside from ragweed. She said that she had the Penicillin when she was a kid and Keflex as a young adult. Caller does not have the NDC, Lot, or expiration dates for the Penicillin, tetracycline, or Keflex. Lot: SBF021, exp:Aug2021. The only other time that this happened was 2 years ago when she got her flu shot and the year before that. The first year it was mild reaction and 2 years ago it was the size of a golf ball. This year she had nothing from the flu shot. She took Benadryl last night and was surprised when she saw that this morning. It usually wards off any allergy attack. She did not take a whole one and stated that it knocks her out so she only took a half. The patient said that she took a Advil every 4-6 hours and attributed the well being to that. The patients concomitant medications was not reported. The patient was calling about the COVID-19 Vaccine and said that she received the first shot on 20Jan2021. She said that everything had been fine until this morning and it had been 2 weeks. She had no sore arm. On 20Jan2021, patient experienced a headache for a minute for like 2 days. On 21Jan2021, she had nausea lasted a few minutes then it was gone. Caller said that her headache and nausea symptoms were so fleeting that she did not even report it. She said that it was so mild that it was almost insignificant it was so mild. She said that she did report it at the safety reporting system and at the (Website name) for the vaccination check in. One day on an unspecified date, she did feel strange and on 22Jan2021 she had general malaise, she just felt something was wrong and it lasted about 30 minutes. She said that it was a general feeling that she was not well. She said she took a Advil and ignored it. The patient clarified that last night she started scratching underneath her ear, thought she was going to have a break out, but on 04Feb2021, she woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site. She said that it is no where else, no else on her body. On an unknown date, she felt fine and her throat was not closing and she was not having any trouble breathing or anything. She stated that the spot under her ear was gone. She put Neosporin on it. It was gone this morning. She said that this place on her arm was more of a hard place and a rash now on an unspecified date. She knows the body remembers and years down the road you could get a pain from a injury or surgery. Last night she felt a sharp pain in her right arm. She ignored it and this morning she woke up with this. It is not as hot or red, but it is still raised. The clinical outcome for the events headache recovered on 21Jan2021, nausea recovered on 22Jan2021, general malaise was recovered on 23Jan2021. The outcome for woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site was recovering. The clinical outcome for the other events was unknown.
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| 70 | 2021-04-28 | amnesia |
Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hour...
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Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hours, could not answer any questions had lost memory; This is a spontaneous report from a contactable consumer (patent). A 70-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 09:45; at the age of 70-years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient received the first dose of bnt162b2 on 02Feb2021. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. No Covid tested post vaccination performed. The patient experienced Transient ischaemic attack (TIA) on 13Mar2021 and was admitted to hospital, she could not answer to any questions and had lost memory. The patient had no memory of 24 hours, could not answer any questions had lost memory. She also complained headaches every day since this has happened (as reported). The reported events were headache (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Transient ischaemic attack (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Amnesia (have no memory of 24 hours), (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae. Information on the lot/batch number has been requested.
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| 70 | 2021-04-28 | sleep disorder |
4/20/21, after vaccine I was sleepy/tired. 4/21 I was fine. 4/27/2021 10:30 p.m. I begin to feel ext...
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4/20/21, after vaccine I was sleepy/tired. 4/21 I was fine. 4/27/2021 10:30 p.m. I begin to feel extremely fatigued & coughing. Went to bed. Woke up at approx 12:30 a.m. with high fever, chills, aches, coughing, racing heart, shortness of breath. Took 1 extra strength Tylenol. Tossed & turned. Got up 1 hr later. Drank about oz of apple cider vinegar with water & took 1 1000mg vit C. Tossed & turned until approx 5 a.m. then fell asleep. Woke up at 7:00 a.m. feeling better but still achy & slight fever. Woke up at 9:00 a.m. All symptoms gone slightly weak. Ate pack of instant oatmeal. Could only taste the sweet not the oatmeal. By noon I was completely back to myself and taste had returned.
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| 70 | 2021-05-10 | insomnia |
fatigued; hypersensitivity to light, sound and smells; was unable to eat; feel off with stomach; som...
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fatigued; hypersensitivity to light, sound and smells; was unable to eat; feel off with stomach; some joint pain; increasing joint pain and muscle aches; headache; Did not sleep; excessive pain in all joints( pain on the bottom of my feet)/very sore arm; This is a spontaneous report from a contactable consumer. A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EM 9809) via an unspecified route of administration on left arm on 02Feb2021 11:00 AM at single dose for covid-19 immunization. Medical history included Lyme disease (I had lyme disease within the last 3 years) and Allergy. Concomitant medications were not reported. The patient reported, on 09Feb2021 08:30 PM, day after injection she had very sore arm, Wednesday, begun to feel off with stomach and some joint pain. On Thursday, she had increasing joint pain and muscle aches and a base of the skull headache and did not sleep at night. On Friday, it was full blown excessive pain in all joints (pain on the bottom of my feet) and was unable to eat, tried to stay hydrated and slept for one hour at night. On Saturday, hypersensitivity to light, sound and smells, evening all symptoms started to go away and on Sunday, patient was recovering but still fatigued. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of the event fatigue was recovering, and rest of the events was recovered.
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| 70 | 2021-05-18 | excessive sleepiness |
pain with bowel movements; lack of appetite; lost 25 pounds; white blood cells being elevated; pain ...
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pain with bowel movements; lack of appetite; lost 25 pounds; white blood cells being elevated; pain in hip and knees; platelets were a little high; low iron reserves; wants to go to sleep; Bone pain; Chills; Low grade fever; Migraine; headaches; lightly sore arm/pain in her legs; slept extra; lightly sore arm/pain in her legs; This is a spontaneous report from a contactable Nurse (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided),via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:15 (at age of 70 years old) as single dose for COVID-19 immunization. Medical History included: IBS Diagnosed over 20 years before, Arthritis From 1992, Asthma From 1980, Diabetes Diagnosed in 1995 or 1999, something like that, allergy to latex. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 03Mar2021 (at 70 years old) at single dose for COVID-19 immunization; The patient had a Flu vaccine and the pharmacist put the needle through the Band-Aid to give it her. The caller then developed a red spot at the injection. She thinks it was because there was latex in the bandage and she is allergic to latex. The patient underwent lab tests and procedures which included body temperature: 100 on unknown date, low grade fever on 04Apr2021, strep throat test: negative on 01Apr2021, Platelet count: a little bit high on 26Apr2021, COVID-19 virus test: negative on 04Apr2021, negative on 07Apr2021, negative on 24Apr2021, White blood cells: being elevated on unknown date, 13.7 on 24Apr2021, weight on unknown date: lost 25 pounds. Patient had Migraine From 03Apr2021, Reporter seriousness for Migraine was Disabling. Low grade fever from 04Apr2021, Reporter seriousness for Low grade fever was Medically significant, Disabling, Bone pain from 05Apr2021, Reporter seriousness for Bone pain was Disabling, pain with bowel movements From Unknown, seriousness for pain with bowel movements was Disabling, Chills From 04Apr2021, Reporter seriousness for Chills was Disabling, lack of appetite From Unknown, Reporter seriousness for lack of appetite was Medically significant, lightly sore arm from 25Mar2021, Reporter seriousness for lightly sore arm was Not serious, wants to go to sleep From: 05Apr2021, Reporter seriousness for wants to go to sleep was Unspecified. The caller is calling to report her side effects on the Pfizer COVID vaccine, the second dose. The caller received her second dose of the Pfizer COVID vaccine on 24Mar2021 and she had a lightly sore arm with a dull ache and pain the first day and that next day, it responded well to Tylenol. 9 days later (03Apr2021), the caller had a migraine with aura for 2 days and she hasn't had a migraine in 20 years. The highest it got was 99.9 axillary. Caller clarified that she had chills and bone pain- on unknown date pain in her legs, hip and knees. The caller was burning up but also freezing at the same time. All of this lasted for about 4 days and then went away. 9 days later, all of this started again so she went to see the doctor on Saturday, 24Apr2021. The caller was told to come back on Monday, 26Apr2021, and she had blood work done: Her platelets were a little high and they said it was low iron reserves. The caller insisted that the doctor start her on an antibiotic so on 30Apr2021 they started her on cefdinir 300mg one twice a day for 10 days, she is still taking this. The caller started feeling a lot better but then her symptoms started again- the aches, fever, chills, and deep bone pain in her femurs. All of this felt like when the caller had walking pneumonia once, the bone pain. The caller's bone pain is in her knees, back, and lower pelvis in the groin area. This is still going on. The caller has lost 25 pounds because of her lack of appetite (both on unknown date, medically significant). The caller mentions that she usually runs a subnormal temperature so her low grade fevers are scaring her. The caller wanted to make sure these symptoms weren't a reaction to the vaccine. Something is going on with the caller, with her white blood cells being elevated on unknown date. The patient slept extra on 25Mar2021. The migraine went away, but she has had headaches (03Apr2021) every now and then with these aches and pains. This is debilitating and really depressing. The bone pain is deep and severe and her bones hurt, its really effecting the quality of her life. Right now she is having pain in the hips and groin area and the bone area, but she is not having fever right now. The doctor on call said to take Tylenol and ibuprofen around the clock and drink lots of water but she gets a low grade fever about once a day. The caller has been taking the Equate brand Tylenol- expiration date Sep2022, lot: BLV2169 or 8LV2169, she is not sure, unknown NDC. The caller has been taking the store brand Ibuprofen 200 mg she takes 2-3 of those if she needs them- lot P12201, expiration date Sep2022, unknown NDC. The caller had to stop her blood thinner to take the ibuprofen. The caller has IBS which has been much worse since all of her other symptoms started happening. The caller would have severe pain with bowel movements but the Bentyl has helped that a lot. The doctor on call said to take Tylenol and ibuprofen around the clock and drink lots of water but she gets a low grade fever about once a day. The caller has been taking the Equate brand Tylenol- expiration date Sep2022, lot BLV2169 or 8LV2169. The caller has been taking the store brand Ibuprofen 200 mg she takes 2-3 of those if she needs them- lot P12201, expiration date Sep2022, unknown NDC. The caller insisted that the doctor start her on an antibiotic so on 30Apr2021 they started her on cefdinir 300mg one twice a day for 10 days, she is still taking this. The caller started feeling a lot better but then her symptoms started again- the aches, fever, chills, and deep bone pain in her femurs. All of this felt like when the caller had walking pneumonia once, the bone pain. NDC, lot, and expiry not provided for Cefdinir. The caller has IBS which has been much worse since all of her other symptoms started happening. The caller would have severe pain with bowel movements but the Bentyl has helped that a lot. Caller stated she already spoke to the safety department but did not have any reference number to provide. Caller Stated she received the second Pfizer COVID vaccine and wanted to know if similar side effect were reported of what she is experiencing and the length of time. She received her second dose on 24Mar2021 and from 03Apr2021 she is having Migraine headaches, On 04Apr2021 she had fever and chills. they resolved and stated again 9 days later. She tested negative for COVID. Has really bad "bone pain" loosing weight, no appetite, pain is still there. her white cells count is 13.7 (24Apr2021), she is getting antibiotics. her side effects are intermittent. The caller's temperature was 100 and her son had strep throat so she went to the urgent care and got tested for strep. The Nurse Practitioner there said she had typical side effects from the vaccine. Physician office visit for all events. Treatment received for event Migraine, Low grade fever, Bone pain, pain with bowel movements, Pain in extremity, headaches, Platelet count increased, Iron deficiency. The outcome of the event Migraine was recovered on 04Apr2021, Bone pain was recovered in 2021, lightly sore arm/pain in her legs recovered on 26Mar2021, pain in hip and knees was recovered on unknown date, lack of appetite, lost 25 pounds was recovering, for Low grade fever, wants to go to sleep, slept extra, Chills, pain with bowel movements was not recovered, for other events was unknown. Event relatedness: Pfizer covid vaccine with lightly sore arm was Related, with pain with bowel movements was Unknown, with lack of appetite was Related. information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-05-20 | confusional state | Patient was admitted for fall at home and confusion |
| 70 | 2021-05-24 | loss of personal independence in daily activities |
swelling in my arm; I had lower back pain, it was excruciating.; Then the next morning the pain star...
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swelling in my arm; I had lower back pain, it was excruciating.; Then the next morning the pain started radiating to my left leg. It was more like my left thigh; then the next morning the pain started radiating to my left leg. It was more like my left thigh; The pain was so bad I could barely walk; This is a spontaneous report from a contactable consumer or other non-HCP. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 70-years-old) as SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced swelling in her arm. After that she had lower back pain, it was excruciating. She took some Motrin and it stopped hurting but then the next morning the pain started radiating to her left leg. It was more like her left thigh. The pain was so bad she could barely walk. It is going on 4 days now and she would like to know if this has been reported with the vaccine. Therapeutic measures were taken as a result of she had lower back pain, it was excruciating. The outcome of event the pain was so bad she could barely walk was not recovered. The outcome of other events was unknown. Information on Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 70 | 2021-05-24 | nervousness |
Dizzy, nausea, extreme tiredness (slept for 6 hours after returning home). Tiredness lasted for ove...
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Dizzy, nausea, extreme tiredness (slept for 6 hours after returning home). Tiredness lasted for over a day. The best I can explain this is "internal shaking". I was so weak that when I tried to get up and move, my body would shake internally. Hard to explain. When I first woke up after sleeping 6 straight hours, I was sweating but I don't know if I had a fever.
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| 70 | 2021-05-27 | anxiety, loss of personal independence in daily activities |
Approximately 3 to 4 was after shot I noticed drooping left eyelid. It worsened in spite of treatme...
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Approximately 3 to 4 was after shot I noticed drooping left eyelid. It worsened in spite of treatment by ophthalmologist. Great difficulty swallowing, talking, much muscle weakness in neck & shoulders, and all over. Unable to eat much because of weakness in throat. Have lost 23 pounds in six weeks. Very week, unable to drive or do much of anything. Husband has become caretaker. Initial diagnosis is mysthenia gravis. Have been referred to neurologist for treatment. Appt June 7.. I am miserable, having anxiety attacks., worried. Doctor advised me report this.
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| 70 | 2021-05-28 | feeling abnormal |
Chills; she threw up; shaking; feel very bad; little cold like she may have a fever; little cold lik...
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Chills; she threw up; shaking; feel very bad; little cold like she may have a fever; little cold like she may have a fever; This is a spontaneous report from a contactable consumer reported for his wife. A 70-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an intramuscular route of administration in left arm on 27Jan2021 at 15:00 (at the age of 70-years-old), as single dose for covid-19 immunisation. No additional Vaccines administered on the Same date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks of the vaccination was received by the patient. No adverse events following prior vaccinations reported. The patient had no medical history, and no concomitant medications were received. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. On 29Jan2021, 2 days after receiving the vaccine, the patient experienced chills, threw up, shaking, started to feel very bad and hadlittle cold and fever. It was reported that she felt fine the day of getting the vaccine and yesterday and about 2 hours ago today, she had bad chills and threw up. She felt better once she threw up. She still feels a little cold like she may have a fever, but the shaking is over. The patient did not visit emergency room and physician Office. No relevant rests were conducted. The event shaking was resolved on an unspecified date in 2021. The outcome of the event threw up was resolving. The outcome of the other events was not reported. The reporter wants to know if these side effects are still associated with the vaccine. No investigation assessment was provided. Information about Batch/Lot number has been requested Follow-up attempts are completed. No further information is expected.
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| 70 | 2021-05-28 | feeling abnormal |
other vaccine same date vaccine date: 14Feb2021; headache; feeling nauseous; stomach queasy; chills;...
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other vaccine same date vaccine date: 14Feb2021; headache; feeling nauseous; stomach queasy; chills; complete lethargy; feel very tired for most of the day; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 14Feb2021 as a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, thyroid disorder. The patient was allergic to penicillin. The patient did not have any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. The patient was not tested for CVID post vaccination. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), gabapentin (GABAPENTIN), atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication. It was reported that every few days the patient experienced for a short time, 1-2 hours, headache, feeling nauseous, stomach queasy, chills, complete lethargy. It resides with Tylenol. The patient then felt very tired for most of the day. The patient felt fine on the days in between. On 14Feb2021 the patient experienced headache, feeling nauseous, stomach queasy, chills, complete lethargy, feel very tired for most of the day, other vaccine same date vaccine date: 14Feb2021 (product use issue). The clinical outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 70 | 2021-05-28 | sleep disorder |
A few hours after vaccination, severe pain/numbness/tingling started in left arm. Severe pain laste...
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A few hours after vaccination, severe pain/numbness/tingling started in left arm. Severe pain lasted several days. Pain is now intermittent, sharp shooting, describes as needles. Pain is often more severe at night, and interrupts sleep for hours. About 10 days after vaccination, pain began in right arm as well. Same pain/numbness/tingling. Currently has symptoms in both arms. Treatments: tylenol, ice, warm compresses, wrist braces, cortizone injection in left wrist, Meloxicam taken for 14 days in mid April. All treatments with little to no effect on symptoms.
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| 70 | 2021-05-31 | insomnia |
really sore and she could not sleep on it; she had COVID-19/tested positive for COVID; left arm was ...
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really sore and she could not sleep on it; she had COVID-19/tested positive for COVID; left arm was very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 11:30 (Lot Number: EN6206) as 1st dose, single for covid-19 immunisation, administered at the hospital. Medical history included high blood pressure, diagnosed many years ago; diabetes, diagnosed 4 1/2 years around age 65 and a half, she is not on Insulin shots, just on Metformin; obese and overweight, she has been heavy all of her life since age 16-17; and allergies to Novocain at the dentist office and allergies to Sulfa. When she had Shingles shot first one, she reacted to it. She took Tylenol and it took care of it. She never went to the ER or doctor. There were no concomitant medications. The patient stated that she had COVID-19. Her quarantine period was 15Mar2021 through 25Mar2021. She received only first dose of Pfizer-BioNTech COVID-19 Vaccine on 04Mar2021 but could not get the second dose since she was still in the quarantine period, getting over the COVID-19 infection. She stated: "I'm pretty much over my symptoms, still have a little bit of cough but nothing dangerous or anything" "They already re-scheduled me for second dose appointment 01Apr2021 and wanted to make sure it is safe, won't make me sick again". The patient was supposed to have second dose on 25Mar2021. She caught COVID in between. She caught COVID on 15Mar2021. She later stated she did not get tested until 20Mar2021 and got results on 22Mar2021. They wanted her to take last shot this Thursday. She wants to know if she will be sick again and is worried. She would like some guidance about getting second dose since she tested positive for COVID after receiving the first dose. She said it took two days to get results because they do not have a fast test where she is. She had a terrible dry cough for 2 days that started on 15Mar2021, or 16Mar2021, noticed a terrible cough at 12:00. By 16Mar2021, she was coughing, but the drainage did not start until 17Mar2021. She still had the cough but a lot of drainage on 17Mar2021. She still has a slight cough, but it is not bad and does not keep her up. Her left arm was very sore on 04Mar2021 at 15:00. It lasted for 2 days. It was really sore and she could not sleep on it. The patient tested positive for COVID on 20Mar2021 at 08:22. The patient's COVID symptoms started on 15Mar2021. No emergency room or physician's office visit required. Outcome of the event left arm was very sore was recovered on 06Mar2021, outcome of event really sore and she could not sleep on it was unknown, and outcome of other event was recovering.
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| 70 | 2021-06-01 | feeling abnormal |
felt like someone was putting pins on her head/it hurt; The joints were hurting/It was stiff; The jo...
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felt like someone was putting pins on her head/it hurt; The joints were hurting/It was stiff; The joints were hurting/It was stiff; When she was asleep she was seeing green and another color bright shells going; someone poking her with a needle in her leg; all over her body it felt like pins going in; stiff; Her knees were hurting; headache; had a horrible feeling and felt like the walls were crawling in; pains all over the body; Eyes are hurting; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: It is handwritten. It is either EW0186 or EWD186., Expiration date: Unknown), via an unspecified route of administration in right arm on 17May2021 as single for covid-19 immunization. The patient's medical history included has been in the hospital three times this last year. They put a lot of shots in her stomach for blood clots. Patient was hospitalized for pneumonia, hysterectomy, and COVID19. She had all the hospitalizations in 2020. When she got home after she had pneumonia, 2 days later she had COVID19 because one of her family members had it. Hospitalizations were prior to COVID shot. She has had fever shot and pneumonia shot and not had this issue. She gets the fever shot every year. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any additional vaccines on same date of the Pfizer Suspect. Patient took COVID shot on 17May2021, Monday and everything was ok. It did hurt when they stuck the needle in. Eight hours later she felt like someone was putting pins on her head. She rubbed it because it hurt. The joints were hurting on her right side where they put it. It was stiff. She did exercise and started moving it because she didn't want it to be stiff. It has been hurting. When she was asleep she was seeing green and another color bright shells going. She was experiencing someone poking her with a needle in her leg. All over her body it felt like pins going in. Patient's knees were hurting. She got up in the morning and last night she had pains all over the body. For 8 hours it was stiff but then it was fine. She also had pain on the left. She has not had a fever. Patient's eyes are hurting on 17 May 2021. It is like a headache, get a little and eyes hurt. She went to work Wednesday, she had a horrible feeling and felt like the walls were crawling in. She is supposed to go in three weeks for second dose. The second shot would be worse, and she feels like that will be a danger. She expressed her concerns about the second shot as she read in the paper that the second one is more stronger. She doesn't plan to get the second one. Something could happen to her with the second shot. The paper said the second shot would have side effects. The people that have done the second shot got sleepy, dizzy, and weak. She want to make sure she can get to work but was still experiencing the adverse events. The outcome of eyes are hurting was not recovered, while with other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 70 | 2021-06-01 | feeling abnormal |
horrible burning feeling like a lit candle in the lower intestines and fire in stomach/ felt like sh...
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horrible burning feeling like a lit candle in the lower intestines and fire in stomach/ felt like she was on fire, body was on fire inside her body; red bumps on my right arm/red bumps in little clusters, cluster of red dots; diarrhea; stomach upset; severe stomach pain; flushed cheeks across her nose/cheeks flushed for 1 hour; my cheeks turn pink; brain fog/felt very loosie; Fatigue/tired; little sore arm/minor sore left arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6205, Expiry Date: Jun2021), via an unspecified route of administration, administered in left arm on 25Feb2021 16:30 as single dose for covid-19 immunisation. Medical history included GERD/gastrooesophageal reflux disease, high cholesterol, ongoing high blood pressure, breast cancer and had radiation for that in 1992, high triglycerides, thyroid removal in 2007, stroke 2012, ongoing oxygen therapy (24 hours a day for 3 years) and allergies to neglect and wheat. Patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) she takes it because she has no thyroid; acetylsalicylic acid (ASPIRIN (E.C.)) 325 mg for high blood pressure; salbutamol (ALBUTEROL HFA), omeprazole, fenofibrate, atorvastatin, lisinopril, latanoprost. She had things wrong with her and she was on several medication beside the oxygen. She had to take a 325 mg of 'Bayer Aspirin' (not clarified) every morning because she had stroke in 2012. She takes at night she takes some eye drops, her eye doctor gave so that she does not get Glaucoma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. She received normal medications for high blood pressure, fenofibric, within 2 weeks of vaccination. The patient previously received influenza vaccine (FLU) shot for immunization and she has never had a reaction. Patient was nervous about receiving the vaccine because she was on oxygen therapy 24 hours a day in addition to being on a number of medications which include: medication for high blood pressure, Synthroid, Aspirin 325mg every morning, and "a couple of things for breathing" such as Albuterol and Respimat inhaler "which helps you get rid of carbon dioxide from your lungs." She just expresses concern because "her body is compromised." She saw on TV that the CEO of Pfizer was discussing the possibility of a third booster shot. Patient was scheduled for next shot on 25Mar2021. She got first Pfizer dose on 25Feb2021 around 4:30 in the afternoon on Thursday, and when she got the first dose cheeks got really pink and they stayed like that for an hour or so and then they went away and she thought it was okay for her to (incomplete sentence). She had all different ones, the first one started right away, as soon as she got the shot she felt very 'loosie' (Not clarified) about 20 minutes later when she was sitting there and waiting. Then when she got, she noticed her cheeks were really pink. Some went away about an hour. Then she had some fatigue and a little sore arm for the next 48 hours but she was okay. But then on 28Feb2021 (yesterday) 48 hours after the shot, suddenly she had diarrhea, very violently and then that was last night and she was so having it and she felt like she was on fire, she felt like her body was on fire inside her body, and she kept drinking." She had pills she had to take every day. No she took nothing. When she had the diarrhea over night from last night almost 48 hours all night long she had diarrhea couple times, and she had diarrhea this morning. She felt like somebody lit a match inside her body and it's like burning from inside, and started drinking water. On continuous home O2, takes synthroid and lisinopril. She experienced flushed cheeks across her nose which lasted a few hours. The first 48 hours she had a minor sore left arm, fatigue, and brain fog. At 48 hours after the vaccine administration, she had to take lisinopril and 5 mins later she experienced violent diarrhea. Later that night felt "fire inside my body like someone had lit fire" started drinking water, "eventually it went away. She called to ask if it was ok to take peptobismol. On 01Mar2021 (Today) she felt way better. She experienced quite a lot of side effects after getting the 1st dose. She said that she was not easy going up. After she got home, she mentioned that her cheeks flushed for 1 hour. She gets flushed usually but this was more pink than usual which went through her nose. The flushing was not hot and swollen. She also experienced horrible burning feeling like a lit candle in the lower intestines and a fire in the stomach 4 days later after the diarrhea on 04Mar2021. She was advised to take Pepto-bismol and water for that and she was fine. She was very tired, fatigued, and her brain was foggy for 4-5 days. She also mentioned that she took some of her high blood medications which made her stomach upset but she ensured to take it with food the next time and it did not happen again. It was challenging and was a wild day. It's been 8 days since and she has mentioned that she's okay now and is breathing better than she usually does, especially on 05Mar2021 (today). She also feels that she has more stamina, improvement in her lungs. She said that it was very strange but she is very happy and is wonderful. She has been on Oxygen for 24 hours a day for 3 years and is more at risk for COVID. She is asking if this is normal and for what to do with the 2nd dose. She was advised to refer to healthcare provider for further discussion. As soon as she had the shot, her cheeks turn pink and she couldn't see it until she got home because of the mask and she does not know if cheeks were pink because of the mask or what but it was only lasted for short time and then went away. She did not have any swelling or heat or anything but when she started, she had very few symptoms except fatigue. Then on the third day or fourth day, she started with diarrhea and a very severe stomach pain and now in the last couple of days she started with these red bumps on my right arm in Mar2021." She had the shot on left arm but has these red bumps in little clusters, cluster of red dots, you can feel them and they are raised up and she does not know if something bite her or if this a side effect. It has been several weeks now. It was on shoulder in two different places and it is kind of like three or four of them at one location. "Now, my cheeks are pink again and it has been two weeks now. She does not understand why. She should not be having any side effect at all and she was all (voice feeble) twenty-four hours a day. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events stomach pain, stomach upset was not recovered; for other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-06-02 | feeling abnormal |
Ear ache; Sore throat; could feel her heart doing somersaults; headache; she had some breathing issu...
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Ear ache; Sore throat; could feel her heart doing somersaults; headache; she had some breathing issues after the first vaccine/was not able to breathe; swelling of he throat,; The buildup was itchy; cold; she was miserable; Runny nose/She always has a little sniffle; she also had SVT in her heart,; inflammation was worsened after the first vaccine/a lot of inflammation/arthritic inflammation; she had fibrin buildup in her hands; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left upper arm on 26Feb2021 11:00 (Batch/Lot Number: EN6200) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Spondylitis, Spondylitis in neck, Inflammation and Arthritis. The caller states that she fell on her knee and got a big bump and with further inquiry, this was prior to the vaccine. Family Medical History Relevant to AE(s) included her father had similar kinds of inflammatory problems, bones, muscle tissue growth. In Jul2020 (at age of 69 years old), patient received shingles vaccine, she wondered if it was still in her system, patient felt awful and more inflammation. The patient's concomitant medications were not reported. History of all previous immunization with no Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No other products. She provided only the birth year, 1951, and said within the first six months. She stated that her weight can fluctuate from 120 pounds to a pound up or a pound or three down. Patient had a runny nose since about a week after the first dose of the vaccine (05Mar2021). She was reluctant to get the second dose because she continued to have a runny nose, almost every day, all day long, sometimes it's worse, sometimes it's better. Her friend was visiting and said that he too has had a runny nose, and he thought it was from wearing a mask, but she didn't wear a mask, but she didn't wear a mask, well she only wear them when she goes out and she's not out that much. When asking for clarification the caller states that the runny nose has been happening for weeks. The runny nose comes and goes. Sometimes she thinks it's getting better and then it got worse again. It's not like a side cold, she always has a little sniffle. It hadn't been bothering her the last couple hours and now it's started to well up and she's thinking what is this about. It started about a week after the first shot and definitely after the second shot. The runny nose was sometimes accompanied with ear ache and sore throat both of which continue to come and go. She didn't know when the ear ache and sore throat started. They come and go quickly, and had happened maybe half a dozen times or more. Her husband would say it's just a cold and maybe it was. She had been treating the symptoms with Elderberry and Zinc lozenges. The caller remarks that she gets a lot of inflammation, described as arthritic inflammation and this inflammation was worsened after the first vaccine on 26Feb2021. She states that this response happened about 4-5 hours later. She also complained of headache, and other symptoms and when asked to repeat the other symptoms she clarified as inflammation in whole body. The caller also reported that something new happened, she had fibrin buildup in her hands on 26Feb2021, she watched it grow on her hands, it was like a science fiction movie; that was still there. She's had fibrin before but never watched it happen. The buildup was itchy and she describes it as an inflammatory response. The fibrin buildup began that night after first dose of the vaccine on 26Feb2021. This started Friday night. The fibrin and inflammation are still there, the only way it will go away was to have it cut out. That was how her body reacts. The caller did report that she had some breathing issues after the first vaccine and was told that it wasn't anaphylaxis, it was probably swelling of the throat, but it didn't last. After the first vaccine she also had SVT in her heart, that night when she was having the inflammation, she remarks that she could feel her heart doing somersaults. The SVT began on the evening of the first vaccine (26Feb2021) and into the next day and into Sunday late afternoon. That was weird, she thought she was doing to die, she was not able to breathe, she was miserable, she thought to sleep it off, she was trying to get away from the headache, it was her whole head. All events did not require a visit to Emergency Room or Physician Office. At the time of this report, the outcome of Runny nose was not recovered, of other events were unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021569236 same patient, different drug dose/event.
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| 70 | 2021-06-02 | memory impairment |
Started experiencing Neurological symptoms; Essential Tremors are very prominent/Motor-hand, head, s...
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Started experiencing Neurological symptoms; Essential Tremors are very prominent/Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair; body is becoming weaker by the week; The EEG is showing a slowing in her memory; She is not able to shower, dress, eat herself.; Walking-very small footsteps (shuffling); Speech-difficulty with word finding, difficulty ordering food mixes conversations; Fatigue - really tired all the time; Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out; Sleeps 9 hours at night/Feels like she can't wake up at all; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 70 years old as single dose for covid-19 immunisation. There was no medical history. No known allergies. No covid prior vaccination. There were no concomitant medications. There was no other vaccine in four weeks, no other medications in two weeks. On 19Feb2021, the patient started experiencing neurological symptoms, and essential tremors were very prominent. She had rapidly declined and was now seeing a neurologist, her body was becoming weaker by the week., She's been to the Emergency Room 2 times to receive help. There wasn't much they can do to help her. She had an MRI and EEG. The EEG was showing a slowing in her memory. She was not able to shower, dress, eat herself. She was a capable women before the shot. Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair, Walking-very small footsteps (shuffling), Speech-difficulty with word finding, difficulty ordering food mixes conversations, Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out, Fatigue - really tired all the time. Sleeps 9 hours at night. Feels like she can't wake up at all. Adverse event start date was 19Feb2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received: Meds for tremors and memory issues. The outcome of events was not recovered. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Feb2021 10:00. Information about lot/batch number has been requested.
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| 70 | 2021-06-03 | confusional state |
Stroke in right parietal lobe and right temporal lobe on May 27, 2021 Left upper extremity numbness ...
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Stroke in right parietal lobe and right temporal lobe on May 27, 2021 Left upper extremity numbness and paralysis Visual and hearing disturbances word problems and mental confusion. 4 days in hospital
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| 70 | 2021-06-03 | fear, loss of personal independence in daily activities |
Stomach was off; She has lost weight; Can't get out of bed if she's lying flat unless she's able to ...
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Stomach was off; She has lost weight; Can't get out of bed if she's lying flat unless she's able to pull on things; Weakness has made her afraid to walk down the stairs; Tired; Exhausted; Very high temperature; Extremely weak; Muscle weakness; This is a spontaneous report was received from a contactable nurse (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6204 and Expire Date: unknown) in left arm, via unspecified route of administration, on 15Mar2021 as 2nd dose, single dose for Covid-19 immunisation. Patient's medical history included ongoing Parkinson's disease, Chronic lymphocytic leukaemia, Sleep apnoea, Chronic fatigue, Hypothyroidism. She has not had any changes to her medications. She has taken the same medications for years. She declines to provide her medication information. The patient also had slight allergy (vomiting) due to Miralax in the year 2012. She had the Miralax in 2012 when she broke her hip, she was at a rehab hospital. The hospital didnt have any prunes so they gave her Miralax twice. The patient's concomitant medication included IgG infusions every 4 weeks. She received her IgG infusion on the days after she received her first and second Covid 19 vaccine. She has been getting IgG for 15 years. She took Tylenol and Benadryl and Prednisone to get her IgG. On 22Feb2021 at 10:30, the patient had received 1st dose of vaccine (Batch/lot number EM9809) on left arm and experienced gas. On 15Mar2021, the patient's temperature was as high as 101.7 degrees Fahrenheit. She did not take any Tylenol for her high temperature because she was told not to with the Covid 19 vaccine. She did ultimately take Tylenol for her temperature and her fever came down. She doesnot recall the exact temperature. It had gone up to 100.9 degrees Fahrenheit and then over the next few days it was around 99 degrees Fahrenheit. She thought she was weak because of the high temperatures. Her stomach felt off, but she drank some Ginger ale. She was weak, tired, and exhausted. She also had her blood tested for Covid 19 antibodies and she was negative for antibodies. Now her primary care doctor is concerned with her muscle weakness and thinks she now has an advanced case of Parkinsons disease. She does have a history of Parkinsons disease before-hand. She had an EMG (Electromyographic Nerve Test) last Thursday, 20May2021 and she has had blood work that has ruled out Myasthenia Gravis and ruled out Guillain-Barre. Her weakness has made her afraid to walk down the stairs. She had to have someone pull her up to the side of the bed. she has lost weight. She reports the temperatures are gone but the weakness has gotten worse. She still cannot get out of bed if she was lying flat unless she was able to pull on things. Her doctor told her she should report her side effects. She just got off the phone with reporting hotline. She reports she has no immunity because of her cancer, and she was hoping she can still receive the Covid 19 vaccine booster if needed. The patient did not receive any vaccine prior to covid-19 vaccine but had sore arm for any vaccine that he had received. Five months ago, she was able to hike and do yard work and now she was basically housebound, mostly. She has been to her primary care doctor on 06Apr2021, and she went to her gynecologist for a routine visit on 07Apr2021. Her gynecologist was upset because she looked so weak. She went to the Cancer clinic on 13Apr for an IgG infusion. She saw a urologist on 07May2021 for a routine appointment. Her appointments with the urologist and gynecologist were not related to her experience with the Covid 19 vaccine. She has had lots of conversations with her neurologist and had not written down the dates she has talked to him. She saw her primary care doctor again today on 28May2021. Her cancer doctor, primary care doctor and her neurologist have all been talking together about her case. The patient undergone lab tests which included body temperature on 15Mar2021,101.7 Fahrenheit and unspecified date in Mar2021, 100.9F and 99F and in Mar2021, SARS Cov-2 test results was negative, weight measurement showed decreased weight, on 20May2021, Electromyographic Nerve Test and blood work reports included Myasthenia Gravis and Guillain-Barre. On an unspecified date in 2021, the patient was recovered from very high temperature and not recovered from extremely weak, muscle weakness, stomach was off, tired, exhausted and weakness has made her afraid to walk down the stairs and outcome of lost weight, can't get out of bed if she's lying flat unless she's able to pull on things was unknown.
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| 70 | 2021-06-07 | anxiety |
Anxious; Shingles; This is a spontaneous report received from a contactable consumer or other non hc...
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Anxious; Shingles; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158, Pfizer NTEC), via an unspecified route of administration in Arm Left on 20Apr2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After received vaccine, one week and a day later she developed shingles on 29Apr2021. She was wondering if this a reported side effect of the vaccine. She was also due to receive the second dose next week and still had shingles. She has never had shingles before. She was wondering if this has been reported. On unknown date she was anxious about the second shot next week. She did not have a prescribing doctor, offered it and she went to a clinic to get it. The shingles are still there, but she was on an antiviral medication so it has improved. It was not spreading anymore. She was on Acyclovir. The outcome of the event was reported as recovering and the event was reported as unknown. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-06-09 | feeling abnormal |
She is under a lot of stress; She has not felt herself in the last two weeks/feels silly; This is a ...
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She is under a lot of stress; She has not felt herself in the last two weeks/feels silly; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 70-years-old, at 2nd dose, single dose for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ XR) in Dec2020 and ongoing for rheumatoid arthritis; methotrexate sodium on an unspecified date. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient had not felt herself in the last two weeks, prior the report, in May2021. She asked if this was common with rheumatoid arthritis or the product. She had been told it could be the weather. She felt silly. She was under a lot of stress and it could be the stress. She asked if there were any reactions from methotrexate sodium, tofacitinib citrate and BNT162b2 combined in the system. The action taken with tofacitinib citrate and methotrexate sodium was unknown. The outcome of the events was unknown. Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 70 | 2021-06-09 | loss of personal independence in daily activities, fear, depression |
Woke up Sunday morning with bloody nose...bruises all over my body...had a million red dots all ove...
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Woke up Sunday morning with bloody nose...bruises all over my body...had a million red dots all over my body....capillaries were bleeding under skin ...this is called....Petechiae Went to doctor Monday ....platelet count was negative two...was rushed to hospital...a week in hospital...still getting infusions weekly due to adverse vaccine reaction...research showed I was number 37 who had this reaction and one person had died due to this...my doctor is now treating three additional patients with this....SOMETHING MUST BE DONE....I feel compensation for my pain and suffering and way of life has changed....had to have a port placed to have infusions...I am tired all the time because platelets are so low...limited activity due to necessary infusions weekly...frequent headaches...stressed...depressed...bruise easily.....fear of contacting COVID because I can?t get second vaccine...
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| 71 | 2021-01-07 | fear |
hives; face swelling; itching; rash; This is a spontaneous report from a contactable nurse (patient)...
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hives; face swelling; itching; rash; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), intramuscular in left arm on 22Dec2020 11:08 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high, ongoing cholesterol, ongoing depression. Concomitant medication included atenolol (tablet, strength 50 mg) from an unknown date and ongoing for blood pressure high, simvastatin (tablet, strength 20 mg) from an unknown date and ongoing for cholesterol, paroxetine hydrochloride (PAXIL, tablet, strength 40 mg) from an unknown date and ongoing for depression. The patient experienced hives, face swelling, itching and rash on 27Dec2020. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccination within 4 weeks was none. She got the first Covid 19 dose on 22Dec2020 and was fine, then on 27Dec2020 she had hives, itching, and face swelling for several days. Caller stated her lungs were clear and she was okay other than the extreme itching. The face swelling was what worried her. The hives and itching went away within about 36 hours. The face swelling kind of got worse for a couple of days before it went away. Caller verifies she recovered from the hives/rash/itching within 36 hours. She got a steroid shot and things like that and it went away pretty quickly. The face swelling was completely gone but did last for a good 5 days. She didn't know if this reaction was related to the vaccine. She wanted to call and let Pfizer know and see if there was any reports of anything else like that or similar to that type of reaction. She was not sure if that really matters or not except she was not sure about taking the booster. She was kind of leaning towards taking the second vaccine. She didn't have any breathing issues. She asked as far as the second dose after those side affects, was it recommended? Her doctor said she could get the second one and prescribed her an Epi pen and would give a dose of Benadryl at the time of the second vaccine. She may take some Benadryl before getting the second vaccine and have her EpiPen with her just in case. She hadn't seen her doctor about this experience with the COVID-19 vaccine. She only went to an urgent care. The caller stated she went to urgent care twice. She received a steroid shot but doesn't have any name, NDC/UPC, Lot number or expiration date for any of the medication she received. She probably threw that paperwork out. She knew she wasn't given anything the second time she went to the urgent care. The second time she went back was because the face swelling was getting worse. She was prescribed an EpiPen and was told to take Zyrtec which did help. Everything had gone away. She would consider these events to be medically significant because of the face swelling, it kind of scared her. She made the comment she was taking high blood pressure medicine and cholesterol medicine, but other than that she was very healthy. She was not really an allergic person. She had not had any testing done since she received the vaccine. She did have bloodwork done prior but not since the vaccine. The patient underwent lab tests and procedures which included blood work prior vaccine with unknown result. The outcome of hives, rash and itching was recovered on an unspecified date of Dec2020 (within about 36 hours); face swelling was recovered on 01Jan2021.; Sender's Comments: Based on the time gap between the vaccine and the events there is not a reasonable possibility that the reported events were related to the suspect product, events are most likely due to patient underlying contributory factors The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 71 | 2021-01-17 | confusional state |
71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liv...
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71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver, asthma, and heart condition was tested for COVID-19 on 01/07/21, received 1st dose of Pfizer COVID-19 vaccine on 01/08/21, positive test result for COVID-19 received on 01/09/21. She was sent to the hospital and admitted on 01/12/21 after O2 was 70% and was in a confused state. Patient passed away on 01/17/21.
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| 71 | 2021-01-17 | loss of personal independence in daily activities |
Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm ...
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Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm on 1/12/21. When I woke up on 1/13/21, I was very sick. I felt like I had a severe, very bad, horrible flu. I didn't get out of bed until 5pm that evening. No fever. No body or joint aches. Just extreme, overwhelming fatigue and feeling flu-y. This phase lasted about 24 hours. (my right am also hurt, but that was minor) I have a severe case of Sjogrens, a systemic autoimmune disorder. My most debilitating Sjogrens symptom is overwhelming fatigue. If I weren't retired, I would be qualified as disabled. Handicapped tag, etc. Since the vaccination, my Sjogrens has "flared." I feel terrible, exhausted, can't do anything. I have cancelled everything. All I can do is sleep, and feed the cat. I am directly connecting this Sjogrens flare to the vaccine. When I'm in a flare this bad, I usually take a course of prednisone. I have not done this because I don't want to modulate my immune system while it is building covid antibodies. I can't wait for the 2nd vaccine on 2/2/21!
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| 71 | 2021-01-19 | feeling abnormal |
I felt fine while monitored in the parking lot for 15 minutes following injection. On my way home at...
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I felt fine while monitored in the parking lot for 15 minutes following injection. On my way home at 25 minutes post injection I had an over-all body wave-type feeling (somewhat similar to a sustained hot-flash) and over-all disconcertingly odd feeling. This lasted about 4 minutes and was followed by shakiness that lasted about 5 minutes (total time a bit less than 10 minutes). Took my bp, pulse, O2 as soon as I got home (approximately 5 minutes post symptoms) and the readings were fine.
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| 71 | 2021-01-20 | memory impairment |
couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a ...
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couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 10Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving her Covid19 vaccine on Sunday 10Jan2021, reports feeling "heavy", chills, and a headache on Sunday 10Jan2021. On 11Jan2021 Monday afternoon she reports that she "couldn't remember the 4-digit passcode to my phone" or her address, but that her memory came back "in a second". The event couldn't remember passcode for the phone or her address was reported as recovered and unknown for the other events. Information on the Lot/Batch number has been requested
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| 71 | 2021-01-21 | feeling abnormal, excessive sleepiness |
Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. ...
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Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. Stomach was queasy. Unable to drink coffee. Tried to push fluids and tried to just eat bland foods. Would wake up sporadically but was unable to awaken enough to watch an entire TV show. Pretty lethargic and brain fog. Was able to wake up a little more on Wed 1/20 but still had the queasy stomach. Started getting Headache and Eye pain and severe upper leg and lower back burning & cramping, I tried taking tylenol which helped a little. By Thursday the pain was worse. I was still tired only walking helped the pain. It got worse if I sat down and extremely bad if I laid down to try to sleep. It's Friday morning & I am planning to go to med check this AM. Symptoms still ongoing
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| 71 | 2021-01-25 | anxiety |
Attendee reports 5 minutes post vaccine chest tightness, palpitations and apprehension. No other sym...
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Attendee reports 5 minutes post vaccine chest tightness, palpitations and apprehension. No other symptoms. EMS notified and transported to local hospital for evaluation
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| 71 | 2021-01-25 | anxiety |
1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 hea...
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1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 heart rate 90 2pm 176/72 heart rate 90 sat up 160/90 gave OJ to drink released 2:30 178/88 heart rate 80 Instructed to seek medical attention if further problems. Was walked to car
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| 71 | 2021-01-25 | anxiety |
Pt was sitting in observation area after vaccine administation and reported feeling "woozy" to RN at...
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Pt was sitting in observation area after vaccine administation and reported feeling "woozy" to RN at 0920. Pt reported mild nausea and lightheadedness, denies any other sxs. RN requested assistance from site lead and RN sat with Pt for about 5 min and instructed to take slow breathes then walked Pt closer to nurse's station. Pt reported feeling some anxiety but was starting to feel better after sitting near RN. Advised Pt to stay for 30 min observation instead of 15 min and Pt agreed. At 0944 Pt reported all sxs had resolved and ambulated out of building with steady gait in stable condition.
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| 71 | 2021-01-25 | sleep disorder |
I am experiencing symptoms similar to that when I had Covid in October,2020. My head is aching, sin...
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I am experiencing symptoms similar to that when I had Covid in October,2020. My head is aching, sinuses aching and ears aching. I?m extremely tired but the pain keeps me from sleeping much.
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| 71 | 2021-01-28 | feeling abnormal |
fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, bra...
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fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, brain fog
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| 71 | 2021-01-30 | anxiety |
3 minutes after receiving Pfizer Covid 19 vaccine patient reports that her tongue started to tingle,...
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3 minutes after receiving Pfizer Covid 19 vaccine patient reports that her tongue started to tingle, roof of mouth and lips started to tingle then face started tingling around mouth. Lightheadedness also reported. States that she felt anxious. Patient/friend reported to EMT at 1:30 after waiting 20 minutes in the holding lot. BP 159/88, HR 96, O2 97. Patient requesting to leave. Friend/driver insists she stay. 1:40 No change in symptoms. Given 25 mg of Benedryl PO. 1:50 PM BP 142/85, HR 73. Patient reports symptoms still the same but not worse. States that same thing happened with reaction to sulfa drug which happened about 20 years ago. Patient again requesting to leave. Dr called at 2 PM. Instructed to hold a total of 30 minutes and if symptoms still the same patient can leave. 2:10 PM BP 137/81, HR 72. Patient reports that she still feels the same but still no worse. States now feels sleepy from Benedryl. Friend states that she will take her home and stay with her the rest of the afternoon. Patient reports that she will talk to doctor about reaction to vaccine.
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| 71 | 2021-02-02 | anxiety |
Pt noted after approx 15 minutes a tingling/burning sensation of tongue At 4:45 pm. No associated ...
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Pt noted after approx 15 minutes a tingling/burning sensation of tongue At 4:45 pm. No associated SOB, facial swelling. She does have prior anaphylaxis reaction to pineapples for which she carries and epi Pen but has never needed to use. Cardiac exam RRR Lungs CTA bilat HEENT, no visible erythema of face or tongue and no noteable facial swelling She was agreeable to 25 mg dose of diphenhydramine and another 15 minute observation. During this time, she began to feel anxious and a mild headache. Vitals at that time were notable for bp 178/81, HR 101 and o2 sat 98%. Still no SOB, facial swelling or other new complaint. She felt improvement in anxiety within 5 minutes, and repeat vitals in 10 min with BP 152/83, HR 89 and O2 sats 96% She still continued with mild sensation change of tongue, but no facial swelling. She does have benedryl at home but I also sent her home with additional 25 mg dose in case she noted recurrent symptoms on the way home . She understands to seek emergency care with any worsening symptoms, or new SOB or facial swelling. She can also use her EPI pen if needed. She felt comfortable returning home- husband picked her up. I will call her to check in this evening and in the morning and will provide updated recommendations regarding second dose of vaccination. I spoke with patient at 8:09 pm - she was at home- feeling much better, however, she did take the second diphenhydramine on the way home, as she began to feel she was having some swelling between her eyes. No SOB Or trouble swallowing. This improved with the second benedryl and has not recurred. She will take an additional 50 mg benedryl before bed, and then she awakes before 6 am- if she has any residual symptoms she will take another dose. Again, she understands to seek emergency care with any worsening symptoms, or new SOB or facial swelling. She can also use her EPI pen if needed. She felt comfortable with this plan. We also reviewed current CDC guidelines and she understands at this time we would not recommend she receive the second Vaccination. She will continue to follow CDC in the event that this recommendation changes. I will submit a VAERS report after following up with her in the morning. ADDENDUM 2/3/21: I spoke with patient again on 2/3/21 at 07:45 am. She is feeling almost completely back to baseline this morning, but planning to take 25 mg diphenhydramine this morning as well. She does note mild headache, which is not abnormal for her. No residual tongue sensitivity or facial swelling. She noted that when she got home last night, she felt very sleepy and sedated from the diphenhydramine and went to bed, and did not take an additional dose of diphenhydramine last night. No SOB, trouble swallowing or any new complaint. No urticaria or itching. We reviewed current CDC recommendations to decline second vaccination given her moderate severe allergic symptoms within first 4 hours of first vaccination. She will follow up with PCP or kidney specialist if she has any continued concern with ongoing symptoms or new issues. She was very appreciative of the followup and care provided.
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| 71 | 2021-02-03 | feeling abnormal |
In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then...
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In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then noticed I had chills. Probably after 8AM I took my temp and I had a fever (102F) for about 10 hours. Started aching all over, joint and muscle aches, I also had headache (took Motrin and headache went away), no pain at the injection site. Almost like I had flu symptoms. I felt miserable all day but next day when I woke up I was fine. Went to work as normal the next day. I forgot to state I had COVID in March 2020 and the symptoms I had felt very much like it.
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| 71 | 2021-02-03 | nervousness |
Within 15-minutes of vaccination, the patient reported a headache and feeling nauseous. EMS managed ...
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Within 15-minutes of vaccination, the patient reported a headache and feeling nauseous. EMS managed the patient's condition on-site.
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| 71 | 2021-02-04 | feeling abnormal |
assume she had covid as well; assume she had covid as well; Feeling bad; Upper respiratory infection...
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assume she had covid as well; assume she had covid as well; Feeling bad; Upper respiratory infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported different events for two patients (herself and her husband), this is the first of two reports. A 71-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in left arm on 12Jan2021 16:30 at single dose for preventing covid. Medical history and concomitant medications were none. No prior vaccinations (within 4 weeks). She and her husband both received their first dose on 12Jan2021. Stated they both have covid. She was feeling bad last Friday (15Jan2021) and she went to urgent care and had a rapid test done that day that came back negative. Her husband went to urgent care this morning and had a rapid test that came back positive. She was told to assume she had covid as well. When she went to physician office for urgent care last Friday (15Jan2021), she was given medication for what they thought was an upper respiratory infection since her test last week came back negative. She was feeling better. The patient underwent lab tests and procedures which included Covid: negative on 15Jan2021. The outcome of feeling bad was recovering, for the rest of events outcome was unknown. No emergency room visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021078480 same reporter/drug, similar events, different patient.
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| 71 | 2021-02-05 | disorientation |
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ...
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Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
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| 71 | 2021-02-05 | sleep disorder |
Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light head...
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Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light headed, extremely tired, sore arm, joint aches Spent the morning in bed and the afternoon on the couch. Temp 99.8 Took tylenol several times during the day and that night. By the following morning most of the symptoms had disappeared with a moderately sore left arm still present.
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| 71 | 2021-02-07 | anxiety |
Patient stated her lips and tongue feel itchy. Patient stated she is allergic to shellfish and gets...
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Patient stated her lips and tongue feel itchy. Patient stated she is allergic to shellfish and gets anxious every time she gets a vaccine. Vital signs within normal limits. BP 128/74, HR 68, O2 sat 96%. Patient took her own Benedryl PO. Patient stated she is feeling better, and she wants to go home.
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| 71 | 2021-02-07 | confusional state |
Immediately after shot, strange head sensations--lightheaded, confused. A minute after that, a tight...
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Immediately after shot, strange head sensations--lightheaded, confused. A minute after that, a tight throat. After 30 minutes, I was released, though still had those symptoms the rest of that day. The EMT at the site thought I'd had a mild allergic response. 36 hours after the shot, I woke up itching a lot on my head, trunk, and arms. I saw no obvious rash (maybe a little mottling) or hives. I used a small dab of Benadryl cream on the itchiest spot. The symptoms disappeared pretty soon.
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| 71 | 2021-02-08 | feeling abnormal |
I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular...
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I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular heartbeat/Pulse 112/Pulse 108/went to 112; checked blood pressure, the lower number was high, upper number lower than what it usually is/130/96/then 110/78; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3247) via an unspecified route of administration on 21Jan2021 10:00 am at single dose in left arm for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included ongoing atenolol for high blood pressure, ongoing amlodipine for high blood pressure, ongoing lisinopril for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually is, it was exactly: 130/96, Pulse 112, then 110/78 Pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It is still bothering her. She had her first shot on Thursday of this past week. She is unsure if this is a side effect. Received the vaccine on 21Jan2021. She says it feels like it is right before you pass out. No treatment received. She is supposed to take blood pressure medication but she is being cautious right now. Her blood pressure medications are: Atenolol, Amlodipine, Lisinopril. She did not take them this morning, all have taken for years. Event outcome of irregular heartbeat was not recovered, while for others was unknown.
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| 71 | 2021-02-08 | nervousness |
Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is h...
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Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met." And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
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| 71 | 2021-02-09 | feeling abnormal, sleep disorder |
Day after pain intense and unable to lift right arm. Later 2nd day pain extended up to right shoulde...
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Day after pain intense and unable to lift right arm. Later 2nd day pain extended up to right shoulder still unable to lift arm. (Had been attempting movement with help of left arm) second night sleep impossible because of pain and sensitivity to any pressure to that arm. Pain moved into back of neck on right side. 3rd day felt like I had a severe flu. Felt bad all over. Again no sleep and pain now includes down to elbow. All of these symptoms have remained fairly consistent up to today(day 6) including little sleep. Taking Tylenol with no affect. Have ERG and have been told not to take Ibupropen.
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| 71 | 2021-02-09 | insomnia |
had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this ki...
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had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this kind of swelled and then like it was steamed; lips and her tongue were all this kind of swelled and then like it was steamed; her arm, both of her arms went numb; could not go to sleep; This is a spontaneous report from a contactable consume r(patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. Medical history included stated, the only thing was got the susceptible to blood clots, had that gene so that is one of the reasons took the vaccine other than that did not take any meds. The patient didn't even take any blood thinners because did not need them." (not clarified further). No concomitant therapy included. The patient did not know if it is the vaccine but she got really weird smell and then her lips and her tongue were all this kind of swelled and then like it was steamed. The patient stated, "In the tongue and my lips, it was like when you get chilli on them and a distinct type of smell. " And then her arm, both of her arms went numb and she had like sort of a hard time breathing. Now, that it went away but she just waited and waited and it lasted almost in the most of the night and then she could not go to sleep but it was something she had never had before and it was very strange. She did not know if you have that kind of reaction from people or you know if it has come up but she thought she better report it because she had not had my second dose yet. She had to get the second dose on 09Feb. No treatments were received. Outcome of the events was recovering.
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| 71 | 2021-02-10 | feeling abnormal |
Her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out; ...
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Her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out; Dizzy; Her head felt funny dizzy, like full headed like she was going to pass out; Head became funny, and her body felt funny; Her blood pressure was 160/("something, I don't remember, but it was high"); Her heart was going to pound out of her chest "blow right out of my chest."/her pulse was in the 90s at that point; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 27Jan2021 10:30 at single dose for covid-19 immunization. Medical history included she had Grave's disease in the past and her thyroid was irradiated, hypotension, arthritis, stress, macular degeneration, glaucoma, hypertension, Blood cholesterol abnormal, Dry eyes, other medication allergies. Concomitant medications included vitamin b complex (B COMPLEX) for Stress, liothyronine sodium (CYTOMEL) for Hypotension, ezetimibe for cholesterol, fish oil for Macular degeneration and Glaucoma, hydrocodone bitartrate/paracetamol (LORCET) for Arthritis, xantofyl/zeaxanthin (LUTEIN ZEAXANTHIN) for Macular degeneration and Glaucoma, levothyroxine sodium (SYNTHROID) for Hypotension, carmellose sodium (THERATEARS) for Dry eyes, triamterene for high blood pressure, tocopherol (VITAMIN E) as something good to take, latanoprostene bunod (VYZULTA) for Glaucoma, and Multivitamins took once daily by mouth took for 15 or 20 years as feel she should take, all of them were ongoing. The past drug history included before starting latanoprostene bunod (VYZULTA) for Glaucoma, she was on other products that she reacted to including 'Timerol'; 'Represso'; and Bimatoprost (LUMIGAN). During the 15 minute waiting period after administration, patient stated at around 11 minutes she felt as if her heart was going to pound out of her chest "blow right out of my chest", she became dizzy, head became funny, and her body felt funny. Patient stated that they called for the paramedics in which they ran an electrocardiogram (EKG), her pulse was in the 90s at that point, and her blood pressure was 160/("something, but it was high"). Patient stated that they had her wait an additional 20 minutes or so and then she left, but it was about an hour and a half before these effects went away. Patient asked if she should receive the second dose of the vaccine. Heart rate was back down to 90 bpm and her EKG was okay. They told her to wait for 15 minutes in her car; she was sitting talking and she had a couple of minutes left on her wait time when suddenly and she grabbed her chest and her heart, her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out. She put her head on the steering wheel and her friend signaled the paramedics to the car. The paramedics examined her, took her blood pressure and it was a little high 160 over something. The feeling went away and she sat there for about 20 minutes until she was able to drive. One hour to one and one-half later she felt normal. The outcome of the events was recovered on 27Jan2021.
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| 71 | 2021-02-10 | sleep disorder |
Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interrupti...
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Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interruption
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| 71 | 2021-02-11 | sleep disorder |
I presented at ER with burning, throbbing right leg pains at upper calf and upper thigh area. The E...
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I presented at ER with burning, throbbing right leg pains at upper calf and upper thigh area. The ER doctor said it was not a blood clot, but was the beginning of Shingles on the back of my right thigh, buttock and downward just below the back of my knee. I was prescribed Acyclovir, Hydrocode with Tylenol and suggested topical creams. I was unable to find the Zostrix suggested so began with Caladryl and Terrasil cream as well as baking soda/water soaks a couple times a day. As of today, February 12, I still have leg pain, markings from the lesions and am unable to sleep more than a couple of hours a night without throbbing, burning pain especially at 2 lesion sites. Now taking Tylenol alternating with Tramadol for the pain.
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| 71 | 2021-02-12 | depressed mood |
Experienced depressed thinking, including suicidal thoughts in the very early hours of 2/11/21. Thro...
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Experienced depressed thinking, including suicidal thoughts in the very early hours of 2/11/21. Throughout the daytime (2/11/21), I experienced general malaise and lacked motivation to do anything. However, slept well the night of 2/11 through 2/12 and felt fine from 2/12 onward.
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| 71 | 2021-02-14 | loss of personal independence in daily activities |
weakness, decreased ADL's requiring assistance, incontinence, decreased appetite, decreased fluid in...
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weakness, decreased ADL's requiring assistance, incontinence, decreased appetite, decreased fluid intake, and became bedbound 2 days. On 2/15, resident is improving slowly
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| 71 | 2021-02-14 | nervousness |
Pt began to feel light headed after receiving covid vaccine did not eat breakfast, was feeling nervo...
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Pt began to feel light headed after receiving covid vaccine did not eat breakfast, was feeling nervous about getting shot. Did not take her HTN medication this AM. 1130 Pt felt fine after 15 min. 1130 BP 138/90, HR 52, RR 10; 1145 BP 138/88, HR 55, RR 10, O2 99%
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| 71 | 2021-02-17 | insomnia |
Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperatu...
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Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperature up only one degree; Chills; Unable to sleep; Body ache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm, on 22Jan2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history included slightly high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 12:15 PM, the patient experienced extreme fatigue, stuffy nose followed by runny nose, coughing and sore throat at night, slight headache, temperature up only one degree but chills, and unable to sleep due to body ache. These events ended quite abruptly on 29Jan2021. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 29Jan2021.
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| 71 | 2021-02-17 | insomnia |
passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chil...
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passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
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| 71 | 2021-02-18 | disorientation |
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; re...
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Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 71 | 2021-02-18 | insomnia |
I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I ...
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I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I had only a brief episode of chills, nausea and cough for several days. My arm was sore. My second shot 21 days later was a different story. I had it in right arm because my left arm was still aching. ( 01/21/2021 ) date of my second vaccination. Since then I have continually had pain "all over my body" My bones and muscles literally ache so badly I cannot sleep. I have called for appointment with my Dr because it isn't going away. I had a cough ( I never cough) until this past week. My concern is the ongoing aching and soreness in different spots on my skin bones and muscles. My shoulders, neck and pelvic region.
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| 71 | 2021-02-19 | loss of personal independence in daily activities |
1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excru...
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1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excruciating stabbing electrical pain on the right side of brain since 2/15/21 3. Joints ache, back hurts started 4 days after injection 2/15/21 4. Feverish, malaise, started 4 days after Pfizer 2 on 2/15/21 5. Pfizer vaccine shot 2 has impacted my life negatively since date of injection 2/15/21. I am not well enough to get out of bed and participate in my daily routine. I need ice on my head for non stop headache and stabbing head pain. Side effects suck.
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| 71 | 2021-02-22 | sensation of foreign body |
4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, he...
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4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, headache, cold feet/hands & back, light headness -feeling might pass out, sneezing, coughing, extreme fatigue,nasal discharge, loss of taste, nausea, stomach ache, knots in throat (very painful) & swelling.
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| 71 | 2021-02-23 | nervousness |
Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noti...
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Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow/still having the swallowing; Congested head, head felt congested, not like pressure; Fingertips a little numb and tingling; Fingertips a little numb and tingling; This is a spontaneous report from a contactable consumers (one is the patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269), via an unspecified route of administration on 03Feb2021 at 10:40 at a single dose on the right arm for COVID-19 immunization, ibuprofen (manufactured by other company, strength: 200 mg, lot number: 7AE1784B, expiry date: Nov2018), oral from an unspecified date and ongoing at 400 mg, as needed for an unspecified indication, hydrochlorothiazide (strength: 25 mg), oral from an unspecified date and ongoing at 25 mg, once a day (about 8am) for high blood pressure, and valsartan (strength: 160 mg, expiration date: 11Nov2021), oral from an unspecified date and ongoing at 160 mg, once a day (about 8am) for high blood pressure. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. The patient previously took flu shot about 15-20 years ago for immunization and experienced swelling. On 03Feb2021, patient received the vaccine. When going home, she noticed all of a sudden a rash of heat from her neck up to her head. Figured it was not a problem to have a little reaction and thought nothing of it. She had a cup of coffee this morning and not a lot of water, so she started drinking water and had 3 bottles. After the heat passed she noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow. She is still having the swallowing and is continuing to drink water even at home. She also congested head, head felt congested, but not like pressure. She does not get headaches so she guesses she is getting this instead of a headache. She noticed her fingertips feel a little numb and tingling, but overall feels okay. She mentioned that on an unspecified date, she just got this nervous feeling and had allergic reaction to bee sting. Mentioned that her husband and brother in law got the shot and were feeling fine. No further details provided. The action taken in response to the events for ibuprofen was dose not changed , for hydrochlorothiazide was dose not changed, and for valsartan was dose not changed. The outcome of the event rash of heat from her neck up to her head was recovering; event got nervous feeling was unknown, while the other events was not recovered.
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| 71 | 2021-02-23 | sensation of foreign body | Numb tongue; feeling of fullness (lump) at back of throat. |
| 71 | 2021-02-26 | irritability |
large elevated (swollen) round rash on left arm with hardness in middle. Noticed it day after injec...
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large elevated (swollen) round rash on left arm with hardness in middle. Noticed it day after injection (2/25). Became itchy on 2/26. Faint inner circle inside larger rash. Mildly annoying but strange looking. This did not occur after 1st injection on 2/21 Pfizer EL9265.
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| 71 | 2021-02-26 | mental impairment |
pt complained of nausea and dizziness 5 minutes post injection. Pt with elevated blood pressure 188...
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pt complained of nausea and dizziness 5 minutes post injection. Pt with elevated blood pressure 188/88 decreased mentation
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| 71 | 2021-02-27 | feeling abnormal |
12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted...
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12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted 2-3 days, but the following symptoms are still present (10 Days post 2nd dose): HA, lethargy, fogginess and tiredness
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| 71 | 2021-02-28 | anxiety, panic attack |
Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 min...
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Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 minute observation time, was feeling fine and left. She returned to the vaccine clinic around 1415 reporting that she was having trouble breathing. Security called the charge nurses and alerted them that a patient needed assistance. Writer came out to patient who was seated in her car. We assessed patient who was visibly having difficulty breathing and was unable to respond to questions without difficulty breathing. Emergency medication box was opened and epinephrine was prepped. We assessed patients allergies and recent medications taken. Patient denied hx of breathing problems or anxiety. Pt denied chest pain. Per protocol for potential allergic reaction, 0.3ml of epi was given at approximately 1426 via IM injection in the pt's left arm. ED triage nurse was called and asked to come assist. Two ED technicians with stretcher arrived and with writer accompanying them transported pt to ED.
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| 71 | 2021-02-28 | fear |
I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in...
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I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in my stomach; Lot of pain in my whole body; Chills especially at night; Tinnitus; I can't hear you very well because it's so bad. I have a lot of noise in my ear and I can't listen you very well. I couldn't hear; Little side effect of the vaccine, but it continued till now and I feel so sick now; scared because she was falling; scared because she was falling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration on 21Jan2021 (also reported as on Wednesday) at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medication included glimepiride (GLIMEPIRIDE) for diabetes and olmesartan (OLMESARTAN) for blood pressure high. It was reported that the patient was experiencing for over a week a lot of side effect of the vaccines. She was scared because she got dizzy which she was almost falling (also reported as scared because she was falling) in Jan2021. The patient also had headaches (a lot of headaches) and every day she had to take pills. She also felt like nauseous and pinch in her stomach. She had a lot of pain in her whole body and have chills especially at night after she had the COVID-19 Vaccine. The patient also had got a lot of tinnitus (lot of noise in her ear and can't listen very well) she can't hear very well because it's so bad. She also felt so sick now that she doesn't feel like doing nothing just to be in bed. The patient events were not recovered (continued till now). Information on the Lot/Batch number has been requested.
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| 71 | 2021-03-03 | confusional state, feeling abnormal |
Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 min...
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Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 minutes then was ok After 1 hour I had I think like brain fog and hard time to navigate my phone. Seem just like confused or light headed kind of during day. Misplaced phones or things next day Next day at night just felt around 11pm getting ready for bed my head was ok and I could think ok again
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| 71 | 2021-03-03 | sleep disorder |
Rapid, strong heartbeats felt in neck and head woke me at approx 4:30 a.m. Blood pressure was 185/10...
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Rapid, strong heartbeats felt in neck and head woke me at approx 4:30 a.m. Blood pressure was 185/102. Took BP meds (.5 mg Ramipril and 25 mg hydrochlorothiazide). Waited 15 minutes and BP was 167/101. Waited another 15 minutes and BP was 149/91. Saw doctors PA in the afternoon, BP was 162/81. PA administered EKG, blood work, and spent a significant amount of time listening to heart, lungs and carotid arteries. Everything was in normal range except sugars, but an A1C test was normal. PA said to take an extra Ramipril at night and track BP at home for 7 days. BP went down each day and on 2/26 was in normal range. However, after 7 days, she said to permanently stay on the evening addition of Ramipril.
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| 71 | 2021-03-04 | anxiety |
Pt felt lightheaded after vaccination. Pt was brought into the medical room and lied on stretcher to...
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Pt felt lightheaded after vaccination. Pt was brought into the medical room and lied on stretcher to rest. Pt initial vs were elevated for bp and hr. Pt was anxious. After 15-20 mins pt felt better and lightheadedness was gone. Pt vs were better and bp hr decreased to normal levels ( 138/87, 94). Pt was released. To observation area and pt checked out.
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| 71 | 2021-03-06 | anxiety | Patient was anxious, with elevated BP 150/108 (HR 117). Final BP 143/82 (pulse 78). |
| 71 | 2021-03-07 | amnesia |
My symptoms from the gadolinium worsened after the vaccine. Increased neuropathy in extremities, lo...
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My symptoms from the gadolinium worsened after the vaccine. Increased neuropathy in extremities, loss of short term memory, tightness of skin on face, nose numb, sympathetic nervous system engaged, no ability to get out of fight or flight.
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| 71 | 2021-03-07 | confusional state |
For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A ...
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For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A week after got hot flashes. Then sucsided During the second week I had an episode when I felt like fainting, Throughout the week I am increasingly tired to a level of total exhaustion and bewilderment. I have extreme reservations about taking the second shot as I never felt so extremely exhausted
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| 71 | 2021-03-07 | excessive sleepiness |
Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site,...
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Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
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| 71 | 2021-03-08 | anxiety | Anxious, Shaking, Jittery ,fast heart beat. ill at ease. |
| 71 | 2021-03-08 | sleep disorder |
With my first vaccine shot on 2/1/21 I developed a small itchy spot on my neck immediately following...
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With my first vaccine shot on 2/1/21 I developed a small itchy spot on my neck immediately following injection. The doctor on site recommended waiting there at the hospital to monitor it for a few minutes, and I did, and the spot went away. My second vaccination was 2/24/21 and the next day, around noon, I started to have a back ache. Late afternoon I became a little light headed and slightly queasy. That night the pain started in my joints - neck, shoulders, all down my back. They became rather intense, and at one point during the night, after I had managed to fall asleep, I was awoken with burning pain in both elbows, and random sharp pains in toes and fingers. I took Tylenol through the afternoon and night. The following day I was still sore, but not in pain. Then all symptoms disappeared. Not severe enough to seek medical attention but thought I ought to report symptoms for medical research reasons.
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| 71 | 2021-03-09 | feeling abnormal |
About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her lef...
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About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her left hand started stinging all over. Both legs started getting a strange warm sensation, the size of a pea that kept getting warmer. She was not able to get up or open her eyes, doesn't know if she passed out but apparently went to sleep and slept for 3 hours and woke up and went to bed. She then had toe cramps on her left foot, then got up and walked around the bed and laid down again and fell asleep until the morning. She did not feel normal until 3/5/21. On Sunday, 3/7/21 had nausea, took something for that and the next day she was fine.
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| 71 | 2021-03-10 | impaired work ability |
Dizziness Narrative: To whom it may concern patient is requesting administrative leave for 03/07/...
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Dizziness Narrative: To whom it may concern patient is requesting administrative leave for 03/07/2021 and 03/08/2021 because of dizziness and feeling unbalanced due to taking the second COVID-19 shot
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| 71 | 2021-03-11 | hallucination |
This patient developed a severe, multisystem inflammatory syndrome after covid vaccination that nece...
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This patient developed a severe, multisystem inflammatory syndrome after covid vaccination that necessitated hospitalization for 6 days. It involved skin (rash), liver (elevated bilirubin and asT/alt), bone marrow (leukopenia, thrombocytopenia), cns (hallucinations, visual disturbance), and musculoskeletal system (synovitis). Inflammatory markers were markedly elevated with ferritin over 1000 and CRP over 100. COVID infection was definitively excluded.
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| 71 | 2021-03-12 | sleep disorder |
woke at1 am with pain, that made sleep impossible, diarrheas', nausea, chills , fever; still experi...
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woke at1 am with pain, that made sleep impossible, diarrheas', nausea, chills , fever; still experiencing at 2"15 pm
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| 71 | 2021-03-14 | disturbance in attention |
I cannot move my pinky on my hand and my whole hand you know it feels like it is a nerve or somethin...
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I cannot move my pinky on my hand and my whole hand you know it feels like it is a nerve or something; I cannot think straight; the whole hand hurts; Hand of the arm where injection was placed is numb; a lot of pain; I could not move my thumb on my hand, very painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EN5318), via an unspecified route of administration on 04Feb2021 01:15 at a single dose in left arm for COVID-19 immunization. Medical history included hypertension/high blood pressure, diabetes. No other vaccine in four weeks. The patient was not a pregnant. Concomitant medication included atenolol, valsartan (DIOVAN) for high blood pressure, glimepiride for diabetes, gliclazide (GLIZA) for diabetes, insulin for diabetes. The patient had the first Covid shot (Clarified as Covid19 vaccine Pfizer) on Thursday (04Feb2021) and the next day (05Feb2021), the patient could not move her thumb on her hand, very painful. The patient experienced hand of the arm where injection was placed is numb and in a lot of pain on 05Feb2021. Now (06Feb2021), she cannot move her pinky on her hand and her whole hand you know it feels like it is a nerve or something. She did not know what it feels like and it is on the same hand as she got the shot. She cannot think straight. She believed it was later that night, going into the morning. Well, it might have been in the morning more. Probably in the morning and then the rest of the hand hurt me and now her pinky, the whole hand hurts. She cannot move it and it hurts that much. The patient underwent lab tests and procedures which included height: about 5'1, weight: about 200 lbs on an unspecified date. Adverse event resulted in none of the above. No treatment received. No known allergies. The outcome of events was unknown
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| 71 | 2021-03-15 | disturbance in attention, feeling abnormal, confusional state |
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce...
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Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
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| 71 | 2021-03-16 | anxiety |
pt was experiencing extreme anxiety prior to vaccination today, high bp following initial dose with ...
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pt was experiencing extreme anxiety prior to vaccination today, high bp following initial dose with dizzy spells, pt is alert and stable, resting comfortably, pt bp returned to wnl after spending time in the observation tent, observed pt walking- pt is steady, no dizziness, pt felt comfortable to drive herself home.
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| 71 | 2021-03-17 | confusional state |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Medium
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| 71 | 2021-03-18 | feeling abnormal |
pt said tongue and lips felt funny - no breathing issues- some pressure in her chest- within 10 -1...
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pt said tongue and lips felt funny - no breathing issues- some pressure in her chest- within 10 -15 minutes of vaccine her blood pressure was 167/82 at one point but lowered to 125 /80 within 30 minutes she took 50mg of liquid benadryl she did not want to go to er since no breathing issues - she said she would go to hospital if she felt bad later
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| 71 | 2021-03-18 | insomnia |
Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on th...
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Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on the legs, arms, hands, and shoulder, sore legs, very weak, difficult to sleep.
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| 71 | 2021-03-18 | nervousness |
With the first vaccine I had a strong hypoglycemic episode 30 hours after the injection. The next d...
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With the first vaccine I had a strong hypoglycemic episode 30 hours after the injection. The next day, about 24 hrs. later I became very dizzy but didn't develop shaking, diaphoresis, or black spots in my vision. (I've had hypoglycemic episodes rarely, maybe every several years, but I know well what they feel like. No further episodes since then. I wasn't prepared for the episode and didn't have candy or orange juice handy. It required I lay down for 10 minutes while I was very shaky and cold, clammy diaphoresis. Pita Chips helped---I presume. Yesterday I received the second dose and 29 hours later I started getting hypoglycemic again but quickly drank some concentrated sugary lime juice. I remained slightly shaken but never developed black spots or diaphoresis. I still felt too light and shaky so I had another half glass of juice and feel normal after about 10 minutes. When I reported this, my daughter, who is an ER doctor, was doubtful the first time it was vaccine related because of the 30 hour gap. Before receiving the second dose, the doctor there also didn't believe it was related for the same reason. But I find it very odd now that after both vaccines, at around the 30 hour mark, I had the same effects. Except for a slight migraine- like headache, no other real symptoms----maybe some lethargy. I'm not diabetic, so I'm not on insulin or diabetic pills. I take a lower dose of blood pressure meds and have well-controlled hypertension. I can't even remember the last time (in years) I had hypoglycemia, but I've never had it as bad as I did the first time. Since I caught it this time with the juice and stopped the symptoms, I don't know if it would have reached the level of the first dose of vaccine.
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| 71 | 2021-03-20 | insomnia, thinking abnormal |
fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep f...
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fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep from pain and disturbing thoughts, exhaustion; not able to sleep from pain and disturbing thoughts, exhaustion; Disturbing thoughts; This is spontaneous report from a contactable consumer (Patient). A 71-year-old female patient received first dose of BNT162B2 (COVID 19, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 06Feb2021 at 11:00 AM in Left arm at single dose for covid-19 immunisation. Patient was not pregnant. Other medical history was reported as none. No known allergies. Other concomitant medications in two weeks included 500 VitC &100 Vit D per day. No other vaccine in four weeks was reported. On 06Feb2021 at 23:00 (11:00 PM) the patient experienced fever, crushing body aches, diarrhea, headache, stomach pain, light sensitivity, not able to sleep from pain and disturbing thoughts, exhaustion. No covid prior vaccination. No covid tested post vaccination. No treatment for event. Outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-03-21 | excessive sleepiness |
Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasin...
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Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side, headaches, fever, sleep interruption, vivid dreams. The left arm which had been vaccinated was extremely sore and remained so, just recently lessening. I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so. I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.
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| 71 | 2021-03-23 | disorientation | Fever sweats chills vomiting disorientation |
| 71 | 2021-03-23 | feeling abnormal |
15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat ...
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15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake. Taken by ambulance to medical center. On route, ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure. When I arrived at hospital, t think I was given dexamethasone and famotidine. I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged. Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
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| 71 | 2021-03-23 | feeling abnormal |
The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias...
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The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier. She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts. She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation. She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection. She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas. As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration. Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202
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| 71 | 2021-03-23 | sleep disorder |
DAY 1 - HIGH FEVER ( UNDER CONTROL WITH THE USAGE OF TYLENOL) DAY 2 - PALPITATIONS (MILD) DAY 3-DA...
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DAY 1 - HIGH FEVER ( UNDER CONTROL WITH THE USAGE OF TYLENOL) DAY 2 - PALPITATIONS (MILD) DAY 3-DAY 5 - PALPITATIONS DAY 6 - WOKE UP AT 3:30 AM DUE TO PALPITATIONS (AND ABNORMAL SINUS RHYTHM) WENT TO THE ER. RELEASED OH HER OWN INSISTENCE
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| 71 | 2021-03-24 | anxiety |
Pt developed lightheadedness after receiving vaccine. VSS. BP 138/71, HR 89, O2sat 100 RA. Denies so...
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Pt developed lightheadedness after receiving vaccine. VSS. BP 138/71, HR 89, O2sat 100 RA. Denies sob, ha, dizziness, cp. Reports anxiety. Discharged in stable condition.
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| 71 | 2021-03-24 | delirium |
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk o...
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Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
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| 71 | 2021-03-24 | excessive sleepiness |
Excessive tiredness. Slept 16 hours straight for a couple of days. I talked to 2 different on peop...
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Excessive tiredness. Slept 16 hours straight for a couple of days. I talked to 2 different on people 3/20/21 on the phone and don't remember talking to them. After sleeping 16 hours I got up and fixed me dinner (which took about 1 hr). I sat down and ate my dinner and the next thing I knew I woke up with my empty plate in front of me. I had fallen asleep again and had slept sitting at the table for another 3 hrs. I was extremely sleepy for about 2 days and them I was fine. Other than being out of it for a couple of days I had no other adverse reactions.
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| 71 | 2021-03-24 | sleep disorder |
Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feelin...
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Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feeling (slight nausea and headache). Got out of bed at 5 AM with headache still present. Fever of 99.4 about 7AM. Headache continued on and off all day with 2 Tylenol. Fever went down but rose to 99.4 approx. 8PM no headache. Woke today, Thursday, at 5 with no headache but a fever of 100.4; went back to bed until 6. After a shower, my temp was down to 99. After exercise, it was 98. Feeling okay right now.
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| 71 | 2021-03-24 | sleep disorder |
severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain ...
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severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain wakes me from sound sleep, ongoing exhaustion, lack of appetite
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| 71 | 2021-03-27 | anxiety |
3 min past vaccine tongue tingling, then roof of mouth and lips tingling, then face. Light headedne...
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3 min past vaccine tongue tingling, then roof of mouth and lips tingling, then face. Light headedness . Anxiety. Admin Benadryl. Will notify PMD of reaction
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| 71 | 2021-03-27 | excessive sleepiness, nightmare |
Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 day...
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Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 days I had body aches, extreme chills, night sweats and nightmares, explosive diarrhia, extreme fatigue (slept 23 hours a day). Each following day I slept a little less, but the night sweats and fatigue lasted for 17 days. My temperature remained around 95.7. This is the sickest I have ever felt, even sicker than the Flu I had approximately 30 years ago! No reaction to 2nd vaccine!
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| 71 | 2021-03-29 | nervousness |
Vaccine was administered during a drive through vaccine clinic. During the waiting period she had s...
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Vaccine was administered during a drive through vaccine clinic. During the waiting period she had some facial flushing and felt nervous and dizzy. She was given Benadryl 50mg po. Symptoms resolved. She was monitored for an extra period of time after resolution of symptoms. She was dismissed to home with instructions to monitor carefully for any further symptoms and to seek medical attention should they occur.
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| 71 | 2021-03-30 | anxiety, sensation of foreign body |
Complaints of feeling a lump in her throat and "an itchy scalp". No swelling noticed in her throat/l...
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Complaints of feeling a lump in her throat and "an itchy scalp". No swelling noticed in her throat/lips. BP higher than normal 153/84 HR 78 O2 98%. Pt appeared anxious but alert and oriented. Own Zyrtec taken by patient due to an allergy to Benadryl. Further care refused and pt discharged home.
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| 71 | 2021-04-01 | mental impairment |
Left arm very sore after injection #1 01/29/2021, so injection #2 02/19/2021 in R arm. Mild AE, fat...
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Left arm very sore after injection #1 01/29/2021, so injection #2 02/19/2021 in R arm. Mild AE, fatigue, GI upset for 2 days. About 3/24/2021, developed diffuse hives bilateral elbows & upper arms, spreading over next week to thighs, ankles, flank; now general. Intense pruritus, sleep disruption, clothing irritates, unable to focus on anything else. No prior history of allergic rash or hives. Derm consult 4/1/2021: ?hypersensitivity reaction? no cause known. Oral antihistamines, topical corticosteroids. Modest transient relief, new lesions occurring today.
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| 71 | 2021-04-01 | sleep disorder |
SEVERE Headache lasted 24 hrs; general malaise, severe leg cramps and pain, body/skin pain like with...
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SEVERE Headache lasted 24 hrs; general malaise, severe leg cramps and pain, body/skin pain like with a Fibro Flare. Could barely walk around house with the amount of pain. Had exact reaction from Vax #1 only it all lasted longer. Difficult to sleep due to pain. 1300 mg Tylonal 8 hr barely touched the headache etc pain.
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| 71 | 2021-04-02 | feeling abnormal |
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur...
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Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
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| 71 | 2021-04-04 | feeling abnormal |
Temperature (102.4), nausea, tiredness, headache. Sorry I actually took the vaccine. Did not seem...
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Temperature (102.4), nausea, tiredness, headache. Sorry I actually took the vaccine. Did not seem worth the illness that followed it after each shot. This is the 3rd day and there is no longer any temperature but the tiredness and head fog still exists. The effects lasted 3 days after the first shot so I am hoping this will ease after today. After the first injection I had an itchy rash on my left arm so I had the 3nd shot on my right arm and have not gotten a reaction on my arm as of todays date.
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| 71 | 2021-04-05 | feeling abnormal, nervousness |
9:00 Pt c/o abnormal feeling to throat, However, pt couldn't describe feeling clearly. Denies throat...
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9:00 Pt c/o abnormal feeling to throat, However, pt couldn't describe feeling clearly. Denies throat itchiness/pain, tightness or tingling; VS: BP 188/80, HR 76, RR 16, Temp 97.7, SpO2 100% RA, Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulty, Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeat 172/89, HR 70, RR 16, SpO2 100% RA 9:18 Pt left RUH symptom free
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| 71 | 2021-04-06 | insomnia |
every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of ...
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every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; get sick; injection site irritation; wheezy; This is a spontaneous report from a contactable other HCP. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 01Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, diabetes mellitus, cardiac pacemaker insertion from Dec2020 and ongoing, ongoing asthma and covid-19 from Mar2020. The patient's concomitant medications were not reported. On 02Mar2021, the patient stated that every joint in her was so painful, she couldn't sleep, rollover, or walk. she said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything. The patient also had wheezy on Mar2021, get sick on 02Mar2021 and injection site irritation on 01Mar2021. The events joint pain, insomnia and gait disturbances were assessed as disability by the reporter. Outcome of the events insomnia, joint pain and gait disturbances were recovering while outcome of the remaining events was recovered on an unspecified date.; Sender's Comments: The information currently provided is very limited hence the causal association between the suspect drug and reported events arthralgia, insomnia and gait disturbance cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 71 | 2021-04-07 | feeling abnormal, insomnia |
Headache; insomnia; polyuria; tired; weird feeling/blah feeling; slight rash at injection site; This...
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Headache; insomnia; polyuria; tired; weird feeling/blah feeling; slight rash at injection site; This is a spontaneous report from a contactable consumer (patient reported herself). A 71-year-old non-pregnant female consumer received second dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection) via an unspecified route of administration to her left arm on 04Feb2021 08:30 AM at single dose for Covid-19 immunization. Facility type vaccine: Other. The patient's medical history included high blood pressure controlled with medication. The patient had known allergies. Historical vaccine details included first dose of BNT162B2 via an unspecified route of administration to her left arm on 14Jan2021 08:45 AM at single dose for Covid-19 immunization. Other medications in two weeks: Yes. On 04Feb2021 06:30 PM, the patient experienced headache, sleepless night, frequent urination, tired, weird feeling/blah feeling and slight rash at injection site. She did not receive any treatment in response to the events. Outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.
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| 71 | 2021-04-07 | feeling abnormal |
After COVID Vaccine #2, I had major brain fog, fatigue and almost constant nausea for two days. It s...
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After COVID Vaccine #2, I had major brain fog, fatigue and almost constant nausea for two days. It stopped for a day, then continued from Monday afternoon and I think still continues today, April 8. However, a week later on Friday April 2, I had an extremely painful abdominal flareup with diarrhea, then blood clots throughout the night which turned out to be ischemic colitis. Hospitalized for three days, had CT scan and then a colonoscopy.
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| 71 | 2021-04-09 | excessive sleepiness |
Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan...
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Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan. All came back normal. March 26, MRI done. That showed a stroke. Then on March 31st, saw Drs. (neurologist). Confirmed the stroke and suggested Speech Therapy. Starting on April 19, Sppech Therapy begins. Since Stroke, I have to sleep 12-15 hours a day.
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| 71 | 2021-04-09 | poor quality sleep, feeling abnormal |
Malaise; Muscle ache; feeling off; felt physically tired; gastric disturbances with a lot of gas; fl...
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Malaise; Muscle ache; feeling off; felt physically tired; gastric disturbances with a lot of gas; flu; body was aching all over; not been feeling quite energetic lately; she hasn't been sleeping well; gastric disturbances with a lot of gas; felt very flushed; overheated; elevated temperature to 98.1; Headache; Nausea; soreness at injection site/intermittent shooting pain down arm of injection site; This is a spontaneous report from a contactable consumer who reported for herself. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6199, via an unspecified route of administration on 10Mar2021 12:30 (at the age of 71-years-old) at single dose for COVID-19 immunisation. Medical history included hypothyroid of non-specified origin, feeling lightheaded, and blood pressure abnormal. Patient stated that she did recently go in to hospital because she was feeling light headed and because of her blood pressure. States they ran a blood work panel, checked urine, kidneys and a CT scan of the brain, and everything came back fine. States that this happened about 2 or 3 weeks before the Covid-19 vaccine injection. States she was seen in the ER and was not admitted to the hospital. Concomitant medications included lisinopril taken for blood pressure abnormal from an unspecified start date and ongoing, started taking it 6 or 7 years ago and states taking it twice a day seems to balance better, and also states she was taking small dose of lisinopril for blood pressure, right now is taking 7mg a day, she was taking 5mg but was trying to bring down blood pressure a bit, upped her dose to 7mg; and thyroid (ARMOUR THYROID) taken for hypothyroid of non-specified origin from an unspecified start date and ongoing. She was recently changed to Armour Thyroid 45mg once a day. She states that this is an ongoing thing and that she recently switched to Armour Thyroid from another thyroid medication. States she has been taking this medication for 6 months. She is getting ready to switch to different medication because she can't get Armour thyroid right now. She also states that the only medications she takes on a regular basis is an immune booster, elderberry tincture. Stated she took this on the day of the vaccine but not the day before. Patient previously took tetanus injection 5 or 6 years ago on an unspecified date. The patient experienced headache on 10Mar2021, malaise on an unspecified date, nausea on 10Mar2021, soreness at injection site/intermittent shooting pain down arm of injection site on 10Mar2021, elevated temperature to 98.1 on 23Mar2021, muscle ache on an unspecified date, feeling off on an unspecified date, felt physically tired on an unspecified date, gastric disturbances with a lot of gas on an unspecified date, flu on an unspecified date, felt very flushed on 23Mar2021, overheated on 23Mar2021, body was aching all over on an unspecified date, not been feeling quite energetic lately on an unspecified date, she hasn't been sleeping well on an unspecified date. Patient stated she was having symptoms and wanting to confirm if they were related. Confirmed that patient is referring to Covid-19 Vaccine. Patient had her 1st injection on 10Mar2021, and initially the main thing she experienced was soreness at the injection site and intermittent shooting pain down the arm of the injection site, which have subsided. Now, 2 weeks after the vaccine she has been having headaches. Stated she had a bit of a headache on 10Mar2021 right after the injection. Stated that it was not immediately but the next day and had subsided. Stated feelings of general malaise, feeling off and slight nausea. Stated she did feel some nausea the first night (10Mar2021) but it did not keep her awake. It was not ongoing. Patient trying to figure out whether these symptoms are normal and if other people are reporting this. Stated that in the information she has been reading, it doesn't indicate the symptoms lasting for this length of time. States she is not running a fever but last night (23Mar2021) had a situation where she felt very flushed, overheated and had a temp of 98.1. States she is normally 96.8, so this was slightly elevated from that respect. States she was having some kind of mild muscle aches, kind of like stiffness from a workout, but that was not the case. Not a severe workout but mild. States that when she got the flu, her body was aching all over. It doesn't really feel that way now. Does not normally take FLU vaccine and is pretty much vaccine free. States that she did get a tetanus injection 5 or 6 years ago. She was feeling pretty okay and now this is coming on over the last week. States she lives with her mother and is her main caregiver. States her doctor is here in town and she intends to contact them. Mentions that her doctor is a family practice doctor but also believes she is an osteopath. She is now experiencing this 2weeks after vaccine. States she had a bit of headache right after the injection, the next day, not immediately, but it has subsided, and has been off and on for the last week. States that normally it seemed like it would leave. This morning woke up with a headache and normally a drink of coffee helps it go away. Today it is lingering, not completely debilitating but noticeable. States feelings of malaise ever since the injection. Has not been feeling quite energetic lately. States that it seems like it comes and goes and that it started more in the afternoon, usually by noon or 1 o'clock. States she hasn't been sleeping well, which is her regular situation. Stated she was experiencing this a few days afterward and is still experiencing it. States that it is not keeping her from doing anything she wants to do except, sometimes doesn't feel so much like doing things. Last night felt physically tired with muscles aches. States they were not extreme but her body really wanted to stretch itself out. Felt like muscles were contracted but they were not. Stated this did not occur the same day as the shot but a few days later. She reported a temp of 98.1 last night, stated she felt feverish but has never anything over 98.1 which was the highest it has been. States she is feeling notably not herself. This morning, the headache doesn't seem to be going away with one cup of coffee. States she would recognize temp of 97.8, which is probably why she feels a bit over heated and feverish. She has had gastric disturbances with a lot of gas. She was drinking a Pro-biotic drink with Kombucha in it, which did help the bowels but maybe she overdid it with that. States they did say it can effect you. States that today she is trying to fast to help balance her out. States she does not normally have a lot of gas. Attributes this more to the Kombucha and that it is also high in sugar. She reported nausea the first day of the vaccination, at night before going to bed. States that it did not keep her from sleeping. States she did not have it when she woke up the next morning. Since then, it has been more off and on. The nausea has not kept her from eating and has not been sick to her stomach. States she is due for her 2nd vaccination next Wednesday, one week from now. She takes care of her mom who is 91. Anytime she goes out, it affects her mom as well. Treatment: Stated that today, started taking a homeopathic for the flu. Provided name as Oscillococcinum (Lot number: 3E0142, expiry date: Mar2023). For headache, she has been drinking coffee and drinking herbal teas for support. The outcome of the events 'malaise and hasn't been sleeping well' was not recovered; outcome of the event 'soreness at injection site/intermittent shooting pain down arm of injection site' was recovered; and the outcome of other remaining events was unknown.
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| 71 | 2021-04-10 | confusional state |
feeling sick/general malaise; severe arthritis; headache; some confusion; some nausea; This is a spo...
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feeling sick/general malaise; severe arthritis; headache; some confusion; some nausea; This is a spontaneous report from a contactable consumer, the patient. This 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201) via an unspecified route, administered in the left arm on 28Feb2021 at 03:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included migraine, arthritis, Meibomian gland dysfunction, and rosacea. The patient had known allergies which were not further specified. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination were not specified. In Feb2021, the patient was feeling sick since receiving the second vaccine, and it's been 10 days. The patient experienced general malaise, severe arthritis, headache, some confusion and some nausea. The patient stated common side effects, but they seemed to be lasting a long time. The clinical outcomes of feeling sick/general malaise, severe arthritis, headache, confusion and nausea were not recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 71 | 2021-04-10 | depressed mood |
extreme fatigue, chills down back, arms and legs, but head on fire started on 1/13/2021 and continue...
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extreme fatigue, chills down back, arms and legs, but head on fire started on 1/13/2021 and continued until 4/7 ...it still may return...it has stopped for 5 days before and then returnedi . in the beginning it was daily & increased when 2nd dose was given 2/3..... fatigue always started in the afternoon & chills a couple eof hrs later both would continue for hours.....after a shower i had to sit ion the toilet seat to dry myself......it was awful ....deepressed by it all.....only anble to fix a bowl of cereal
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| 71 | 2021-04-10 | sleep disorder |
I have no history of headaches. Starting the week after my second vaccination, I started waking up i...
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I have no history of headaches. Starting the week after my second vaccination, I started waking up in the middle of the night with headaches so severe that they brought me to tears and I felt like I was going to vomit. The first headache was the worst. I'd give it a nine in severity with 10 being the worst. Since that first episode, I've continued to have headaches in the middle of the night about every second to fourth night, the last one occurring last night with a severity I'd rate at 7. These headaches are accompanied by body aches all over and fatigue, which may be from a lack of sleep. I can find nothing different in my life to account for these episodes
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| 71 | 2021-04-14 | mental status changes |
Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 -...
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Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 - Hypotension M25.551 - Right hip pain Z79.01 - On apixaban therapy
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| 71 | 2021-04-16 | excessive sleepiness |
felt very tired/became tired then more tired; was very cold/very cold for 6-7 hours; Chills; Letharg...
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felt very tired/became tired then more tired; was very cold/very cold for 6-7 hours; Chills; Lethargic; her temperature and it was 100.8; slept most of day; no appetite; pain where the shot was given; arm hurt more, it had hurt through the night; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an intramuscular route of administration, administered in Arm Left on 06Feb2021 10:15 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced pain where the inoculation was given in the left upper arm started on that day but got worse the next day. She explains that the next day when she woke up at 7:30 am she felt ok but then at 10 am she felt very tired and noticed her arm hurt more, it had hurt through the night. She was very, very tired and then about 10:30 am she was very cold. She had fireplace and electric heater on plus had 2 blankets on her. She asked her husband to go to the car to get her winter gloves and she was wearing scarf. This lasted 6 hours before it resolved. Her husband took her temperature, and it was 100.8. It was reported that she had no appetite during the day. Upon follow-up (16Mar2021), was reported that, 24 hours after first dose of Pfizer chills started, become tired then more tired; then slept most of day. Fever occurred throughout the day topping at 100.3 and was very cold for 6-7 hours, with 2 blankets, scarf, winter gloves while lounging in front of fireplace, plus small electric heater. The patient underwent lab tests and procedures on unspecified date which included body temperature:100.8. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events injection site pain, nasopharyngitis, decreased appetite and upon follow-up the events chills, slept most of the day, lethargic, fever was recovered and outcome for fatigue was recovering and unknown for Pain in extremity. Follow-up (16Mar2021): this follow-up information was received from a contactable consumer and the new information reported includes, additional events was provided along with the onset date and time. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-04-20 | feeling abnormal |
started with felt like someone punched me in my stomach, by the third day after shot i felt terrible...
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started with felt like someone punched me in my stomach, by the third day after shot i felt terrible went to sleep woke up with terrible back and hip ache, chills getting harder to breathe coughing weakness fever couldn't get out of bed to weak 6days . still having problems breathing and still coughing i'm differently not up to par wondering will i ever be I WON'T BE TAKING THE 2ND DOSE.
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| 71 | 2021-04-21 | agitation |
pain in right arm and back into the right shoulder blade> increased through out the follow week deve...
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pain in right arm and back into the right shoulder blade> increased through out the follow week developing around day 10 into not being able to rise the right arm without pain. Symptoms increased into fatigue, flu like systemic reactions of whole body agitated, over stimulated electric like quality. Mental agitation. Started using Tylenol every 6 hours for pain. Started icing arm. Emotionally draining. 4/21/21 arm started not to be painful for lifting. Very emotional. Systemic agitation starting to calm down on the 22nd of April.
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| 71 | 2021-04-23 | feeling abnormal |
Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung ...
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Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung when she received the first dose. She felt it running into her vein.; When she took the band aid off, instead of a spot, there was an area of blood; muscle pain; This is a spontaneous report from a contactable consumer (Patient) self-reported. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date: unknown), Injected via an intramuscularly route of administration in left arm on 06Feb2021 at 16:15, as a single dose for COVID-19 immunization. Patient medical history included high blood pressure, diminished kidney and family history like her mother had a breast cancer and father had massive heart attack. Patient concomitant medications included as amlodipine (5mg) daily for high blood pressure start date and stop date was unspecified. Patient did not take it prior to getting the vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not get the adverse events prior vaccinations. Patient experienced felt like it was stung" when received the first dose. Patient could feel warm fluid running through vein on 06Feb2021, and stinging sensation at vaccination site on 06Feb2021 at 16:15 and arm felt like lead and could not raise it on 06Feb2021 at 18:00. When she took the band aid off, instead of a spot, there was an area of blood in Feb2021. And experienced muscle pain in feb2021. Patient took an extra strength Tylenol. The outcome of the event felt like it stung and felt it running into vein and Arm felt like lead and could not raise it was recovering and outcome of the event Stinging sensation at injection site, band aid off, instead of a spot and muscle pain was unknown.
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| 71 | 2021-04-24 | anxiety, feeling abnormal |
She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said th...
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She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said this what she has, almost like a fibromyalgia; Shingles became aggravated; she had had broken toe on the other foot that was killing her; total fatigue, no energy at all; total fatigue, no energy at all; abscess on tooth that will be pulled tomorrow; She doesn't have the strength that she had before; This is a spontaneous report received from a contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiration date: UNKNOWN), dose 2 via an unspecified route of administration on 11Mar2021 12:00 as SINGLE DOSE, dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN620) as SINGLE DOSE for covid-19 immunisation. The patients medical history included ongoing asthma since she was 4 years old, ongoing herpes zoster (Shingles) since Nov2019, Raynaud's phenomenon for 20 years, High anxiety, gastroesophageal reflux disease from 4 years. Concomitant medications included amoxicillin at an unspecified dose taken for an unspecified indication for 7.5 days from 29Mar2021 to 05Apr2021; Advair Disc at an unspecified dose taken for an unspecified indication for maybe 30 years she is prescribed twice a day but takes it only once day, fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL) taken for an unspecified indication from an unspecified start date and ongoing; she had been on this for maybe 30 years, as needed, montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing for 30 years, multivitamin, sambucus nigra, sodium, zinc (MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC) taken for an unspecified indication from an unspecified start date and ongoing, she says she has been taking this forever because she never ate vegetables, magnesium sulfate (MAGNESIUM SULFATE) taken for bowels from an unspecified start date and ongoing from around 4-5 years as it helps with her bowels, felodipine (FELODIPINE ACTAVIS) taken for an unspecified indication from an unspecified start date and ongoing, for 30-40 years; rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing; calcium, colecalciferol (CALCIUM PLUS D3) taken for bones from an unspecified start date and ongoing for 30 years once menopause started, for bones, famotidine (FAMOTIDINE) taken for an unspecified indication from an unspecified start date and ongoing, says she has been on this for maybe 4 years because she was eating a lot of Rolaids. The patient was also taking for concomitant Products Hair, nail, skin vitamin for hair, nail, and skin health and says her nails are nice and strong, she still has wrinkles, but she says that was part of being old. The patient also said flu shot in Sep2020, pneumonia shot, shingles shot on an unspecified date and had nothing. patient says the first shot was nothing, everything was fine, the second shot she was thinking this is good, everything is good, it was on 11MAR2021 but by 14Mar2021 she was in total fatigue, started to get an abscess on tooth, she doesn't think this was because of shot, she has a prostheses, fake hip, her hip was killing her where the actual bone joint was, she had had broken toe on the other foot, that was killing her, she had no energy at all. She says normally, she is 71 years old, she was very active. She says her doctor takes care of everything, in her case she is asthmatic, everything, he does all of her bloodwork. she has to get this tooth pulled, she had some cadaver teeth put in, she went to the gym, everything was great, all the sudden she has an abscess, she went to her periodontist who says it is bad, it needs to be pulled. She says she was going to get her tooth pulled tomorrow. She reports her shingles seemed to get aggravated, her doctor said she will always have this, when she gets upset, aggravated or anxious it flares up, she is now back on the gabapentin, it is like pins and needles under rib cage where the actual shingles were. She says she was asthmatic but it did not bother her lungs one bit, she did not have any lung issues. She says everything happened on 14MAR2021. She reports that she does find she gets tired, she cooked all day Saturday, she stood over the stove all day, she did nothing but that all day. She says her tooth was bright red, her whole cheek and still, she took the last antibiotics, a heavy dose, last dose this morning too. She reports her foot is not bothering her anymore, her hip is still a little sore. She says she can do 2 miles in the gym, it was hard to exercise with mask on, it is always cold, she can't walk, she's limited to what she can do right now. she said this what she has, almost like a fibromyalgia, she diagnosed herself as having this condition, she Googles it and it says its muscle pain, she doesn't have the strength that she had before, she doesn't have hand strength, stamina, to walk a mile killed her, now she can do 2 miles, she is not 100% of what she was, she's coming along though. prior Vaccinations (within 4 weeks); she got her flu shot in SEP2020; AE(s) following prior vaccinations: She says flu shot, pneumonia shot, shingles shot, and had nothing. The patient was recovering from fatigue and asthenia, not recovered from tooth abscess and shingles and rets of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-04-26 | feeling abnormal, insomnia |
Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a ...
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Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o'clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn't think that she was going to get the second shot, she doesn't want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.
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| 71 | 2021-04-26 | loss of personal independence in daily activities |
On 03/20/2021 woke up to debilitating dizziness. Unable to do daily routines for 4 days. Dizziness a...
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On 03/20/2021 woke up to debilitating dizziness. Unable to do daily routines for 4 days. Dizziness abated slowly over the following three weeks.
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| 71 | 2021-04-28 | insomnia |
on first day, lower left eye weird feeling, very cold, slight headache, tired, 2nd day headache stil...
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on first day, lower left eye weird feeling, very cold, slight headache, tired, 2nd day headache still there getting worse, itchy elbows, day 3 full blown migraine and nothing helped and it was the worst one I've ever had, still tired, ; headache continued for 7 days with full blown migraine from day 3- day 7. Some sleep loss, pain in arm where injection received, then last 3 days of first 7, the pain was in the opposite arm???
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| 71 | 2021-04-28 | panic reaction, feeling abnormal, anxiety |
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain...
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muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
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| 71 | 2021-04-29 | anxiety |
Post vaccine pt became dizzy, felt lightheaded, and anxious. Pt transferred to med obs via wc. Pt re...
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Post vaccine pt became dizzy, felt lightheaded, and anxious. Pt transferred to med obs via wc. Pt reported feeling better after laying on stretcher. Vitals obtained and monitored. Pt had no complaints of chest pain. Pt had no complaints of SOB. Pt released at 15:27. Vitals as follows: 1514 LYING BP 119/68 HR 60 RR 18 SpO2 97% 1520 SITTING BP 120/55 HR 60 RR 18 SpO2 97% 1524 STANDING BP 99/62 HR 68 RR 18 SpO2 97% (PT BASELINE)
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| 71 | 2021-04-30 | amnesia |
noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remem...
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noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; Large brown circle surround site of shot; bruising surrounding it; some welting. Some tenderness; some welting. Some tenderness; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 (at the age of 71-years-old) (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included, neuropathy peripheral, drug hypersensitivity, diarrhoea, vision blurred blurred/double vision since Feb, hypertension Mild high blood pressure. Drop in blood pressure and increase in blood pressure month after Covid, chills, MGUS, non symptomatic ascending aorta aneurysm, pronounced cough, fever, sore throat, flu symptom. I had the virus on 30Nov after being unknowingly infected with virus by someone unknowingly with virus, some 8 feet away, with no direct interaction. Experienced fever 4 days later. tested. Virus positive. Excessive flu symptom-pronounced cough, fever, sore throat. treated w/antibodies some 8 days later. The patient received first dose of BNT162B2 for COVID-19 immunization on 10Mar2021 ({Product=COVID 19, brand=Pfizer, Lot number=EN6199, Lot unknown=False, Administration date=10Mar2021, Administration time=12:30 PM, Vaccine location=Left arm, Dose number=1}]. Concomitant medication included hydrochlorothiazide, lisinopril (ZESTORETIC); bupropion hydrochloride (WELLBUTRIN); naproxen (NAPROXEN). Large brown circle surround site of shot, with additional bruising surrounding it. Not noticed until 18 days after 2nd shot, some welting. Some tenderness. Don't know when first appeared, does not appear to be fading. No reaction after first shot. (There was sudden unexpected loss of consciousness after sudden slumping. Wednesday eve before noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes. Mild concussion with symptoms. Amnesia at time of loss of consciousness. Do not know if two are related. Deep brown circle on left arm noted 2 day later. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Nov2020. The outcome of the events was not recovered.
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| 71 | 2021-05-04 | excessive sleepiness |
Patient is a 71 y.o. female admitted on 5/1/2021 due to falls. Please refer to the History and Phys...
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Patient is a 71 y.o. female admitted on 5/1/2021 due to falls. Please refer to the History and Physical report for information on presentation Patient was admitted to the hospital due to recent multiple falls and hitting her head. Patient family brought her in, reported that she has been very drowsy lately, she barely comes down to eat dinner. She sleeps most of the time. She has been compliant with all her medications. All imaging studies showed no acute findings. Including CAT scan head which showed chronic white matter changes, but no acute finding. Neurology evaluated patient, they have done extensive work-up in the past to rule out falls including lumbar puncture, MRI,eeg However all the testing has been negative. Patient's vitals remained stable. Patient states she just feels her legs gives up. PT eval the patient, recommended rehab. Patient will be discharged to rehab. Patient's medications were also titrated down to decrease drowsiness. Patient remained AAO x3 during hospital stay.
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| 71 | 2021-05-06 | mental status changes | Altered mental state |
| 71 | 2021-05-09 | confusional state |
Hospitalization t did not eat/ drink anything for 72 hours before going into the hospital on 3/31. ...
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Hospitalization t did not eat/ drink anything for 72 hours before going into the hospital on 3/31. Pt began feeling unwell on 3/27 and has been digressing until hospitalization. Pt was noticeably confused and unable to carry a conversation. Pt did not mention change in taste or smell. Pt was warm to the touch but no temperature taken. Pt also complained of chills but this is typical for the pt. Pt had body aches. From Saturday on she was essentially bed ridden. Nausea but no vomiting. Pt rep spoke with the pt this morning and reports the pt is less confused and able to communicate. Pt and pt rep received second dose of Pfizer on 3/3. Pt rep their son-in-law and granddaughter visited around 3/25 and tested (+) on 3/29 or 3/30. Pt rep states the pt has had no other contacts. Pt rep denies travel and congregate settings. Pt rep verbally confirmed guidelines.
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| 71 | 2021-05-13 | loss of personal independence in daily activities |
On 4/1/2021 Patient had at least one seizure at home and upon arriving at the ER/hospital had a seve...
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On 4/1/2021 Patient had at least one seizure at home and upon arriving at the ER/hospital had a severe seizure. She was admitted to the hospital for treatment and was in the intensive care unit for about 9 days. She was given seizure medicine along with other fluids to keep her hydrated and fed. Multiple EEGs were taken to track the electrical activity within her brain - which even with high doses of medication was very active. A spinal tap was done to test for infection and no viruses were found. An MRI was completed to identify what part of the brain was being impacted. The area of the brain that was impacted was the side and the images showed it was very inflamed. She has since been moved to a physical therapy facility to try to help her improve. At this time, she still needs assistance for all activities and would not be able to return home due to the level of care she needs. Her current diagnosis is autoimmune encephalitis. She has never had seizures before and this one began about two weeks after receiving her first dose of the COVID-19 shot. She has been unable to receive her second shot due to being in the hospital and physical therapy facility. Due to the timing of the seizure event, we are very concerned with her receiving her second shot as well.
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| 71 | 2021-05-21 | nervousness, feeling abnormal |
hives; swelling in her throat or tongue; swelling in her throat or tongue; numbness on her lips; str...
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hives; swelling in her throat or tongue; swelling in her throat or tongue; numbness on her lips; straight up her nose, and straight up through her head; It feel like there is pressure in her head; head congestion; She is scared; tongue started being numb; She had a metallic taste in her throat; blood pressure sky rocketed; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left on 24Jan2021 02:15 PM (at the age of 71-year-old) as single dose for covid-19 immunization. Medical history included ongoing trigeminal neuralgia, ongoing high cholesterol and is on a cholesterol medication for that, medicine allergies (multiple drug allergies, She has a lot of allergies. She has 10 medicine allergies). Concomitant medication patient received in two weeks included gabapentin 300 taken for trigeminal neuralgia and Ongoing; montelukast; rosuvastatin and Cholesterol medication. The patient experienced tongue started being numb, she had a metallic taste in her throat, blood pressure sky rocketed on 24Jan2021 14:30, hives, swelling in her throat or tongue, swelling in her throat or tongue, numbness on her lips, straight up her nose, and straight up through her head, it feel like there is pressure in her head, head congestion, she is scared on an unspecified date. It was reported that the patient received an injection of the Pfizer-BioNTech COVID-19 vaccine on 24Jan2021. After the injection, she started experiencing a numbness of the tongue and a metallic taste and her blood pressure was "off the charts". She reports the numbness has progressed from the tongue to the lips and the forehead. She reports her tongue is not swollen although it feels like it is swollen and she has not experienced hives or constriction of the throat. Treatment has included Benadryl and Pepcid. The consumer reports the Benadryl helps but makes her drowsy and when she does not take it, her symptoms worsen again. The consumer reports a history of multiple drug allergies and trigeminal neuralgia. Immediately to 10 minutes after, her tongue started being numb. She had a metallic taste in her throat. Her blood pressure sky rocketed. Her daughter is an ER doctor who knows the EMT that was helping her. She suggested they give her Benadryl, but they only had IV Benadryl. That got her a ride to the emergency room. Her reactions to medications include hives or swelling in her throat or tongue. She has an epi pen which she uses when necessary. She avoids those medications at all costs. Her tongue is not as numb right now. She also has numbness on her lips, straight up her nose, and straight up through her head. It feel like there is pressure in her head. It is different than her Trigeminal Neuroglia. Which is a shooting pain sideways from her left ear. She has head congestion, her lips and nose are numb if she doesn't take Benadryl. If she takes Benadryl, she walks around all drowsy, and she can't drive. She had to run errands today. So she did not take Benadryl, and her tongue is numb again. She is scared about taking the second dose. She can't get the numbness to disappear. When she stops taking Benadryl it feels like her tongue is doubling in size, but it is not. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included blood cholesterol: high, blood pressure: off the charts/sky rocketed on an unspecified date. Therapeutic measures were taken as a result of hives and swelling in her throat or tongue with Benadryl and Pepcid. The outcome of the event tongue started being numb, She had a metallic taste in her throat, blood pressure sky rocketed was not recovered and was unknown for other events. Follow-up attempts are completed. No further information is expected.
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| 71 | 2021-05-26 | insomnia |
insomnia; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female p...
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insomnia; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el64 and expiration date was not reported), via an unspecified route of administration in left arm, on 13Feb2021 (at the age of 71 year old) as 2nd dose, single for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications included fluoxetine hydrochloride (PROZAC) and hydrochlorothiazide. The patient previously took erythromycin and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 3247 and expiration date was not reported), via an unspecified route of administration in left arm, on 23Jan2021 (at the age of 71 year old) as 1st dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced insomnia in the evening on 13Feb2021 and continued for 3 months. Slowly getting back to normal which is when the patient fall asleep within a few minutes after going to bed. It was reported that the patient would still take the vaccine again. The event was considered to be non-serious. No treatment was given for this event. The outcome of the event was recovering at the time of report.
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| 71 | 2021-05-29 | amnesia, disturbance in attention |
Five days after receiving the 2nd Covid-19 shot, Patient started experiencing heart palpitations tha...
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Five days after receiving the 2nd Covid-19 shot, Patient started experiencing heart palpitations that last several hours each day. After this went on for almost three weeks, she decided to visit the Urgent Care on March 18th. They did an ECG and detected bigeminy. Patient had never had this condition prior to the 2nd vaccine. She has experienced heart palpitations now for 13 weeks since going to Urgent Care. These are intermittent. She will have them for several days in a row 4 to 6 hours during each day then they will go away for a few days then return for several more days in a row. Overall during the 16 weeks since the heart palpitations started, she has experienced them on 80% of the days.
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| 71 | 2021-06-01 | feeling abnormal |
I ended up at the hospital because of dehydration and my heart was racing because of HL Fib. I also...
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I ended up at the hospital because of dehydration and my heart was racing because of HL Fib. I also have severe nausea and headaches. The joint pain made me feel really bad. My Doctor became concerned because of my sever heart pains and he was the reasons that I went to the hospital.
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| 71 | 2021-06-02 | feeling abnormal |
bad case of hives; its just annoying and really itchy; its just annoying and really itchy; This is a...
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bad case of hives; its just annoying and really itchy; its just annoying and really itchy; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EL3302; Expiration Date: May2021), (age at time of vaccination was 71 years) dose 1 intramuscularly, administered in Deltoid Left on 21Jan2021 07:30 as single dose and dose 2 (Batch/Lot Number was EN6201, Expiration Date: not reported) intramuscularly, administered in Deltoid Left on 16Feb2021 07:30 as single for covid-19 immunization. Patient had some allergies not provide any further details. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2021. Patient did not receive any prior vaccinations within 4 weeks. The patient's concomitant medications were not reported. She knows the vaccine was a while ago but she wants to know if there have been people reporting any kind of delayed reaction to the Covid vaccine. She now has a bad case of hives, which is new for her. She mentions she is going to see her doctor next week. If the hives are still there, she will see her doctor. She doesn't think its worth going to the ER. The hives are pretty bad on her left shoulder, and she has spots on her back and her trunk/body, kind of on her side. She adds they are itchy. She mentions she has been taking Benadryl and putting steroid cream/anti-itch cream on it. She confirms the hives have stayed the same. No further details provided. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of urticaria. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 71 | 2021-06-02 | sleep disorder |
She got her vaccine at 4:00, felt fine, no problems. Then about 1-2:00 AM on 6/2/21 all of a sudden...
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She got her vaccine at 4:00, felt fine, no problems. Then about 1-2:00 AM on 6/2/21 all of a sudden she had diarrhea and was up all night with that. She did throw up once. The next day she had chills and her head had pressure in it, just did not feel well, lethargic, did not want to go anything or do anything. Her arm was painful, but nothing that she could not tolerate. No swelling to the arm. Today, 6/3/21 she woke up and she is fine. She drank a lot of water and ate a light meal and is feeling back to her normal self today.
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| 71 | 2021-06-04 | depressed mood |
she continued to take her methotrexate and xeljanz medications; I am very upset; This is a spontaneo...
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she continued to take her methotrexate and xeljanz medications; I am very upset; This is a spontaneous report from a contactable retired nurse/other hcp (patient herself). A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left arm/left upper arm on 24Feb2021 (at the age of 71-years-old) as single dose for COVID-19 immunization. She previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, (Expiration date: It says First 31May2021, second it says 30Jun2021) on 03Feb2021 as single dose for COVID-19 immunization. The patient received TOFACITINIB CITRATE (Xeljanz, Batch/Lot Number: Unknown, Expiration Date: Unknown) and METHOTREXATE SODIUM (Methotrexate Sodium, Batch/Lot Number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on an unspecified date for Rheumatoid arthritis. Medical history included rheumatoid arthritis and little higher on hearing from an unknown date and unknown if ongoing. Concomitant medication(s) included blood pressure medicine, Arthritis medicine, cholesterol medicine; however, unspecified and a medicine-Tegretol 200mg. Retired Nurse stated that she was little higher on hearing. She was a Rheumatoid arthritis patient. She had been on Xeljanz and Methotrexate. She took the Pfizer shot in early 03Feb and then repeated again in 24Feb. She was never told to stop her medication and so she got antibody test on Friday and it said that she was negative for antibodies. And she was just wondering could she get a third shot, and asking suggestion. She stated that "I am very upset about all this. My rheumatologist never told me to stop my medication, never get a hold on me anyway". She reported that she continued to take her methotrexate and xeljanz medications the entire time while receiving her vaccinations. She underwent a surgery recently. She was very upset about all this. She wants to know if her medications caused her not to have an immune response and how her antibody test can be negative. The patient underwent lab tests and procedures which included blood test: unknown and sars-cov-2 antibody test: negative with levels less than 100. The outcome of the event was unknown. The reporter stated about causality that retired nurse stated, she thought it was due to the medications (Xeljanz and Methotrexate). Information on Lot/Batch number was available. Additional information has been requested.
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| 71 | 2021-06-07 | feeling abnormal |
Fever, extreme fatigue, loss of appetite, headache, mental fogginess. I had a concussion / TBI on 2/...
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Fever, extreme fatigue, loss of appetite, headache, mental fogginess. I had a concussion / TBI on 2/22/19 in a car accident. My head, around where I had the concussion from centrifugal force, ached where it had been sore from the accident. I felt like I had the concussion all over again. Was in bed for two days with the fever. Fatigue continued for weeks.
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| 71 | 2021-06-07 | mental impairment, feeling abnormal |
difficulty thinking; head pressure; pain in the neck; pressure and headache behind her eyes; pressur...
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difficulty thinking; head pressure; pain in the neck; pressure and headache behind her eyes; pressure and headache behind her eyes; rapid heart beat/Increased heart beat, blood pressure; high blood pressure that wakes her up; high blood pressure that wakes her up; heart is pounding so hard enough to wake her up; fogginess/ Foggy thinking/Felt distinct wiggly/zig-zag line at the top of her hairline, pressure that just pushed on the top of her head; dizziness; Feeling tired all over; Numbness in left arm/lower left numbness of her face; Itchiness all over face; pain in her neck. It felt like a lump or gland; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269, expiration date: 31May2021), via an unspecified route of administration, in arm left, on 02Feb2021 (at the age of 71-year-old), at single dose, for COVID-19 immunization; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207, Expiration Date: 31Jul2021), via an unspecified route of administration, in arm left, on 13Mar2021 (at the age of 71-year-old), at single dose, for COVID-19 immunization. No vaccines administered on same date with the Pfizer vaccine. Medical history reported as "none". Patient stated she was pretty healthy. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), and "zinc". Patient stated she had been taking vitamins such as Vitamin C, Vitamin D, and Zinc even before COVID and continued taking it, but it didn't improve anything because her symptoms were getting worse. Vitamin C (Lot #: 11627, Exp: Jun2022, UPC #:729440860011). It's a combination of a tablet and a powder also. The directions say to take four per day, but she can't say if she takes four or two. She uses the Vitamin C powder- it comes in packets (like Kool-Aid), but she can't remember what it's call. She states she hasn't been super consistent with which bottle she took, but she tried to get it down every day. Sometimes, she puts the powder in her shake every morning. Amount per serving was 1551mg. It was recommended four per day, but she never took four because there are only so many she could swallow. She has to live besides taking pills, and she has plenty of pills to swallow. Vitamin D (Lot #: 192656, Exp: Jul2021, UPC: 818960013516). It's in liquid form, it's called "Liquid D"; the brand is Apex Energetix. The serving size was one drop sublingual, with a total in the bottle of 550 drops. The Vitamin D was 50mcg per serving. Caller states it's really good stuff, she has taken it from a doctor's prescription, that's how come she started taking liquid drops. Zinc (each serving was probably 50mg). No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient reported pressure and headache behind her eyes since the 1st dose of the Pfizer covid vaccine. The patient also added that she had head pressure, a headache across the right side of her head, increased/rapid heart beat, high blood pressure (reported as ongoing and worsening) that woke her up, heart was pounding so hard enough to wake her up, fogginess, dizziness, difficulty thinking, pain in the neck within the 1st 5 minutes of receiving the dose. Since the first part of May it's been constant every night. Patient had both doses of her vaccine, and said within 5-15 minutes after her first dose, she had pain in her neck. It felt like a lump or gland. She had lower left numbness of her face and itchiness. She had pressure in her head, especially on the right side. She was experiencing dizziness, was a little foggy, and it's harder to think. Patient explained it wasn't lower left itching of her face, the itching was all over her face. Patient clarified the first thing she felt was within 5 minutes of getting the vaccine. She parked and felt pain in her neck. Immediately, she could feel a distinct wiggly line at the top of her hairline that slowly kept across her head, past the crown of her head a little ways. It felt like pressure that just pushed on the top of her head, and sort of created a light headache on the right side (reported was ongoing, persistent, and worsened). She also noticed pressure behind her eyes (reported as different than the pressure in her head, but it all comes together and all at the same time. The pressure behind her eyes is ongoing, persisting and getting worse. The pressure behind her eyes didn't use to be this strong), and felt a little dizzy, had foggy/difficult thinking, but it was not within the first 15 minutes. She had numbness in her left arm (it was minimized, improved, and more occasional). Ever since receiving the vaccine, patient's heart, blood pressure had gone up. Her usual range was in the 120s and the lower number was in the normal range, around 60-80's, she couldn't remember. Patient said she was 125 over a normal diastolic range (either 60 or 80, she can't remember what was the normal range). She bought a blood pressure cuff after this happened to observe. The first number was about 20-30 higher than normal, based on the day. The second number was between 77-80 and had been up as high as 89. Patient stated things were not doing well. The eye pressure was a big concern. She wanted to know why was her head hurting behind her eyes. Patient explained all of these things she had mentioned was what she can remember at this point, she was not excluding the possibility that she might remember another one because it has been a while. Some symptoms had minimized. Her concern was the foggy head and pressure would come and go at first and now as of two weeks ago, it had not relented at all. It's constant. Her heart seemed to be like it's pounding harder, she guessed that's her pulse, but she was not sure what it's called. It's to the point that it wakes her up. The earliest it had woken up her is 3:30, up to 5:30-6:00, and which was completely not a normal sleeping habit for her. It's a constant thing. Every day now, she wakes up. The pressure never goes away now, it was sporadic, and now its constant, which was an issue for her. As for "pain in the neck", patient stated the pain in her neck was the first thing she noticed when she received her first dose. Patient said the pain was sporadic, comes and goes. The pain in the neck was more seldom than regular at this point, but she can still feel it. She clarified sometimes when she wakes up, she can just feel sensitivity there, but it wasn't painful at this point. She explained the pain in her neck had improved and was persisting. As for "felt distinct wiggly line at hairline/ zig-zag line at the top of her hairline, pressure that just pushed on the top of her head", patient stated it felt like something was riding a zigzag line at the top of her head- it was very clear and it started moving backwards. Along with this came with the dizziness. She clarified she no longer feels the distinct line itself, but what it created (head pressure, fogginess, and achiness) has persisted with occasional breaks, it would go away and would come back. After the first vaccine, these symptoms were infrequent- she clarifies it was frequent but not constant. For two months, it was sort of pretty regular after the second vaccine. Around 01May2021 (around 3 weeks ago), the head pressure, fogginess (reported as ongoing, persisting, and worsened), and achiness started being constant. It makes her body overall feel like it's tired, it's hard to function. She clarified the wiggly line at the top of head and the head pressure was all related. It started with the line and proceeded back across her head. It's all one big symptom. She thinks that's the pressure was getting worse because it never goes away. She felt tired all over and dizzy (reported as ongoing, getting worse, and was associated with her head pressure). It felt like somebody is standing above her, pushing down on her head, and it's hurting inside like a mild headache. After the second vaccine, patient was told to park by the ambulance in case anything happened since these things had happened with her first dose. No emergency room involved. Patient stated she visited physician office for her primary care, the doctor had no knowledge or treatment in place for these symptoms. The outcome of the event "dizziness", "increased heart beat, blood pressure" was not recovered; of other events was unknown.
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| 72 | 2021-01-14 | feeling abnormal |
At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has con...
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At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has continued with occasional spreading to nose & eyes & sometimes on other side of face - it waxes & wanes Same day - headache, dizzy, exhausted - lasted 2 days Next day - nausea, intestinal discomfort - continuing mildly Mild headache continuing
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| 72 | 2021-01-17 | loss of personal independence in daily activities |
After waking in the AM of the following morning after vaccination, felt total exhaustion and weakne...
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After waking in the AM of the following morning after vaccination, felt total exhaustion and weakness, unable to function with morning duties, left arm sore with a notable lump approximately 2 inches wide. Able to lie down and sleep for about an hour; awoke and felt better. Took two 200mg ibuprofen and laid down again. Within an hour of rest, felt awake with no weakness or exhaustion. Arm was less sore; however placed a warm heating pad on arm throughout the day which improved the lump and soreness.
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| 72 | 2021-01-18 | confusional state |
joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (1...
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joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
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| 72 | 2021-01-18 | nervousness, anxiety |
Client verbalized feeling anxious and nervous. Client was evaluated by Fire Rescue and released to g...
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Client verbalized feeling anxious and nervous. Client was evaluated by Fire Rescue and released to go home 3:21 pm accompanied by spouse.
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| 72 | 2021-01-25 | anxiety | mild anxiety, dizziness 5 mins after injection |
| 72 | 2021-01-25 | feeling abnormal |
her brain is going blank; back pain that occurs in her left leg past the knee until the top of her f...
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her brain is going blank; back pain that occurs in her left leg past the knee until the top of her foot; back pain that occurs in her left leg past the knee until the top of her foot; She wanted to know if it is like a sciatic nerve pain she is experiencing; she just thought it was swelling in her spine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left shoulder on 11Jan2021 at a single dose for covid-19 immunization. Medical history included other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, spinal stenosis, has a lot of back issues, like sciatic has a lot of problems. There were no concomitant medications. The patient had the COVID-19 vaccine on Monday (11Jan2021). On Tuesday (12Jan2021), she experienced back pain that occurs in her left leg past the knee until the top of her foot. She also mentioned that she had other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, and spinal stenosis. She wanted to know if the COVID-19 vaccine can cause the adverse event that she experienced. She wanted to know if it is like a sciatic nerve pain she is experiencing. The patient stated it may sound crazy, but she got the COVID 19 vaccine on Monday, she is 72 years old, and has a lot of back issues, like sciatic has a lot of problems, and she got the shot and Tuesday) morning, her back hurt so bad, down into her sciatic, into her butt, leg, her lower leg and as far as her foot, the top of her foot, and she doesn't know if this is something that was going to happen, she read about joint pain, tiredness, that would include joints in the back, she would expect. She wonders if she is out of her head, since it was the very next morning, this was Tuesday, and instantly, she was sitting with ice and trying to get ahold of her healthcare person, she gets pain shots in her back, but she hasn't had them in a couple years, she was going along pretty good, then this was bad enough, it is in her thigh and leg, and is always under her foot, and she just thought it was swelling in her spine. She wonders if it is a side effect or her imagination. When asked for address, the patient stated her brain is going blank. She stated this may be just her. She has bad back problems, and was going along pretty good, it has been a year or two since she has had any kind of anything. But this was a good one, a strong one, the ice hurts so bad. She woke up with it, it is staying the same- after having something like this, she was trying to get ahold of the pain clinic, to get a shot, but that may be 3-4 weeks out. She has had no blood work in a while. Outcome of the events "she just thought it was swelling in her spine" and "her brain is going blank" was unknown; while not recovered for other events.
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| 72 | 2021-01-26 | insomnia |
extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This ...
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extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This is a spontaneous report from a contactable consumer report self. This 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included had COVID back in Nov2020, blood cholesterol abnormal. Concomitant medication included Pravastatin for blood cholesterol and unspecified water pill. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. Patient received Pfizer covid vaccine on 12Jan2021 around 15:30. Her right arms started getting in pain about 11pm and the pain prevented her from sleeping most of the night till she took an Aleve around 6am. She took another Aleve on 13Jan2021. She can barely raise her right arm and it is ok if she does not try to use it but if she tried to use her right arm then it is inoperable. At 12Jan2021 night after she got the vaccine she experienced itching, she never got a rash, the itching never got bad and it went away. She has not taken her temperature. She was having extreme chills that started around 13Jan2021 3:00 pm and she cannot get warm, she has blankets piled on her. Her neck is aching (started 13Jan2021 afternoon) and she thought this may be from tensing up since she is cold. No emergency room or physician office visit. The outcome of "Itching" was recovered, of else events was unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-01-27 | feeling abnormal |
1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day he...
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1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine. I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning. Hope I don't have to report anything on the 2nd.
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| 72 | 2021-01-28 | feeling abnormal, disturbance in attention |
pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like he...
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pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
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| 72 | 2021-01-29 | memory impairment |
Memory issues and a droopy left eye lid about 16 hours after vaccination. The morning of Jan 30 in H...
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Memory issues and a droopy left eye lid about 16 hours after vaccination. The morning of Jan 30 in Hospital to receive evaluation. Memory issues persist, the droopy eyelid a bit better.
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| 72 | 2021-01-31 | feeling abnormal |
it hurts a little bit if she touches it; arm got red and it was little bump and then it spread and g...
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it hurts a little bit if she touches it; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen/It is a big red mark, probably the size of a lemon; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; felt like she was going to come down with something, she didn't feel right; This is a spontaneous report from a contactable consumer (patient) reported that a 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose as the patient don't want to have COVID. Medical history included arrhythmia, mitral valve prolapse, acid reflux, high cholesterol, and heart murmur; all from an unknown date. Concomitant medications included verapamil, rosuvastatin, pantoprazole, estradiol (ESTRACE), and acetylsalicylic acid; all were taken from an unspecified date for an unspecified indication. The patient had the first dose of the vaccine 3 days ago (13Jan2021) and stated that her arm got red and it was little bump and then it spread and got itchy, and it was a little swollen on 14Jan2021. She also felt like she was going to come down with something, she didn't feel right. It is not swollen today (16Jan2021) but it hurts a little bit if she touches it. It is a big red mark, probably the size of a lemon. The patient took Tylenol, Zyrtec, and put ice on it all last night (15Jan2021), and it became little itchy and this morning (16Jan2021) it's little itchy, still red but the bump is gone. The patient was asked if she still experiencing the events and she stated that the bump was gone, but now it's like red and a little itchy, the red got bigger, it was also like she was coming down with something but so far today she feel okay. The patient underwent lab test with an unknown results on an unspecified date. The outcome of the event 'it hurts a little bit if she touches it' was unknown; event 'it was a little swollen' was recovered and not recovered for the rest of the events. Information on the batch number/lot number has been requested.
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| 72 | 2021-02-04 | anxiety |
1333- Patient complaint of ?feeling flushed in my chest, like reflux?- vital signs 130/94, P-72, O2 ...
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1333- Patient complaint of ?feeling flushed in my chest, like reflux?- vital signs 130/94, P-72, O2 sat 99%; Patient states that she has hypertension and cardiovascular disease. States she has taken her meds today and BP?s are well controlled. Vitals taken and patient offered oral fluids. Patient observed for any additional complaints- none offered. Able to verbalize throughout assessment. By 1345 she states that she is feeling fine and episode has passed. She stated she thinks she was just very anxious. Patient instructed to seek emergency care after departure if need arises- patient verbalized understanding.
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| 72 | 2021-02-04 | feeling abnormal |
Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol...
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Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol and Metamizole..
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| 72 | 2021-02-05 | feeling abnormal |
Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, foggines...
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Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, fogginess. Event lasted about one hour.
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| 72 | 2021-02-06 | anxiety |
Reports chest tightness and anxiety. Evaluated by EMT. BP in 200's. Pt states she forgot to take h...
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Reports chest tightness and anxiety. Evaluated by EMT. BP in 200's. Pt states she forgot to take her BP meds. EKG normal.
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| 72 | 2021-02-07 | insomnia |
Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip f...
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Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.
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| 72 | 2021-02-09 | impaired work ability |
Started feeling unwell several days after shot. Chills fever soaked bed sheets and had to call in s...
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Started feeling unwell several days after shot. Chills fever soaked bed sheets and had to call in sick from work. Did telehealth visit with primary who recommended Covid test which came back negative. Primary advised going to Hospital emergency room for tests-she has been in hospital with pnemonia for 14 days and is now in ICU. Drs treating with high dose steroids, antibiotics and high dose oxygen. She is not recovering.
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| 72 | 2021-02-10 | feeling abnormal |
Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue...
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Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-02-10 | feeling abnormal | foggy feeling, dizzy, pain from injection site up neck |
| 72 | 2021-02-11 | feeling abnormal |
PATIENTS STATES SHE FEELS FUNNY WITH MILD ABILITY TO TAKE A DEEP BREATH. PATIENT HEART RATE IS 70 A...
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PATIENTS STATES SHE FEELS FUNNY WITH MILD ABILITY TO TAKE A DEEP BREATH. PATIENT HEART RATE IS 70 AND REGULAR WITH RESPIRATIONS OF 20. TIMER RESET FOR ADDITIONAL 15 MINS WITH INSTRUCTIONS TO HONK HORN OR BLINK LIGHTS IF IN ANY DISTRESS. PATIENT STATES FEELS BETTER WITH BLOOD PRESSSURE OF 137/79 HEART RATE OF 70, RESPIRATIONS OF 20 AND O2 SAT AT 97%. PATIENT AGREED TO REMAIN FOR 15 ADDITIONAL MINUTES. PATIENT STATES FEELS FINE WITH NO OBVIOUS DISTRESS AND WILL GO TO EMERGENCY DEPARTMENT IF SYMPTOMS RE-OCCUR.
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| 72 | 2021-02-11 | mental impairment |
Patient's response to vaccine was VERY similar to her response to the illness. Lack of body strengt...
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Patient's response to vaccine was VERY similar to her response to the illness. Lack of body strength, stability,(unable to stand by herself, to walk, to follow commands requiring body movement) incontinence, inbility to think clearly, unable to recognize her loved ones, No fever, no vomiting or diarreah, no cough. These symptoms lasted for 24 hours, then went away almost fully and completely. Left arm soreness exists two days after injection.
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| 72 | 2021-02-11 | nervousness |
flu likesymptoms, body aches, chills , patient is no longer feeling those symptoms but last week sta...
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flu likesymptoms, body aches, chills , patient is no longer feeling those symptoms but last week started experiencing"insides shaking". Patient voiced still feeling like "insides shaking" Date and time of vaccination: (list both if they received both shots):1/12/21 11:00, 2/2/21, 11:00 Brand and lot of vaccine:1 vaccine Pfizer lot# EL1283, 2nd vaccine: Pfizer lot #EN5318
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| 72 | 2021-02-16 | fear |
3 hours after receiving the second dose of the Pfizer vaccine, patient broke out into diffuse, eryth...
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3 hours after receiving the second dose of the Pfizer vaccine, patient broke out into diffuse, erythematous and pruritic rash although by exam not consistent with hives. I saw the patient 4 days later and her symptoms were persistent and she was fearful to seek care because she thought steroids might blunt her immune reaction to the virus. She has had multiple similar rashes when she has taken new drugs, specifically antibiotics and antiestrogen therapy for history of breast cancer. She has required oral steroids before for similar rashes.
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| 72 | 2021-02-16 | feeling abnormal |
I woke up feeling ill with chills and slight fever. Overall tired and a bit nauseous. Body feels hea...
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I woke up feeling ill with chills and slight fever. Overall tired and a bit nauseous. Body feels heavy.
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| 72 | 2021-02-18 | feeling abnormal |
Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 m...
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Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 min. 6 hrs later got hot spot burning under my skin in my chest, under my left arm pit to elbow and neck and lower legs. This continues when I get anxious. Like a sunburn just under the skin
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| 72 | 2021-02-18 | feeling abnormal |
Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness a...
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Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness and malaise, mental fogginess, chills and sweats, loss of appetite, slight nausea, needed assistance to walk. Symptoms subsided after two days, therefore did not seek medical attention.
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| 72 | 2021-02-20 | nervousness, poor quality sleep |
On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontan...
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On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontaneously resolved while staff was telling me how they would treat it. Gave me Metoprolol 5 mg IV with 500 IV fluids and discharged. Then on 2/6/21 I slept poorly and felt very jittery and had more chest pressure but pulse was regular. then on 2/8/21 at 6:00 am I awoke and felt terrible with chest pressure. Took my blood pressure at home and it was 193/103, and I was very shaky. Went to ER where they did blood work, X-ray, and monitored my heart and blood pressure for 4 hrs. Gradually my blood pressure came down, and my blood work and X-ray probed to be WNL. I was discharged without medication change but had echocardiogram scheduled and follow-up appt. with Cardiologist, on zoom. He started me on Flecainide 100 mg bid, and stress test on 2/24/21 and follow-up appt. with him on 3/3/21. I also had a follow-up appt. with my GP the day after the first ER visit and she ordered more labs, and the echocardiogram. I have continued to have feelings of fluttering and pressure in my chest off and on and they continued after my second vaccine. But my heart has remained regular since starting the Flecainide. But my blood pressure went up to 150/85 on 2/9/21 and again to 142/81 on 2/10/21 both times with feelings of jitteriness and pressure in my chest.
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| 72 | 2021-02-22 | anxiety |
Patient immediately after vaccine reported anxiety and difficulty talking. Patient took dose of chil...
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Patient immediately after vaccine reported anxiety and difficulty talking. Patient took dose of children's Benadryl from home. States she has had this feeling before when exposed to chemical smells. After 10 minutes patient states symptoms are improving. Encouraged to stay for monitoring for additional 30 minutes. After around 5 minutes, the patient notified staff of symptoms reoccuring and worsening. States she is having shortness of breath, chest tightness and difficulty talking. Patietn evaluated and taken to ED for further treatment. Clinic provider notified.
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| 72 | 2021-02-22 | disorientation, loss of personal independence in daily activities, delirium |
delirium, diarrhea On 02/13/2021 pt entered physician office for incorrect appt date and found to d...
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delirium, diarrhea On 02/13/2021 pt entered physician office for incorrect appt date and found to disoriented. Transferred to Hospital. Pt had in-pt stay until 02/13/2021. Pt discharged to son's care as she was unable to care for herself indepently. As of 02/23/2021 pt has still not returned to baseline.
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| 72 | 2021-02-22 | feeling drunk |
after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing fee...
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after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing feeling on right arm, fingertips numbness
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| 72 | 2021-02-23 | feeling abnormal |
Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. F...
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Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. For two days
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| 72 | 2021-02-23 | feeling abnormal |
feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; he...
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feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient
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| 72 | 2021-02-23 | insomnia | Elevated high pressure, nauseas, dizziness and strong headaches. Couldn't sleep well. |
| 72 | 2021-02-23 | mental status changes |
Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pa...
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Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pass out." Patient had not eaten since yesterday. Given orange juice. Patient began experiencing slight altered mental status (appeared to be losing consciousness in-and-out). EMS treating patient and transported patient to ED.
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| 72 | 2021-02-23 | sleep disorder |
About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, ...
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About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, achy from head to toe but mostly back and sides, nauseous, lethargic and couldn't sleep
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| 72 | 2021-03-01 | hallucination | 102° fever, unable to stay awake, hallucinations, drowsy, 1 night, 1 day, another night and day |
| 72 | 2021-03-02 | feeling abnormal |
She has started developing rash all over her neck and now coming on to arm, it's a very bad rash; Ri...
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She has started developing rash all over her neck and now coming on to arm, it's a very bad rash; Right now it is getting kind of worse; She is feeling very bad after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot ENS318), via an unspecified route of administration from 30Jan2021 to 30Jan2021 at SINGLE DOSE for an unspecified indication. The patient's medical history was not reported. Concomitant medications included diclofenac, gabapentin, losartan, levothyroxine sodium (SYNTHROID), vitamin C (ASCORBIC ACID) and ergocalciferol (VITAMIN D). On 31Jan2021, she was feeling very bad after the vaccine administration and started developing rash all over her neck and now coming on to arm. Reported that it's a very bad rash and right now it was getting kind of worse (no treatment). The outcome of rash aggravated was not recovered; for other event was unknown.
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| 72 | 2021-03-02 | insomnia |
Headaches began later in the afternoon after getting vaccine. Loss of sleep that is abnormal and wor...
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Headaches began later in the afternoon after getting vaccine. Loss of sleep that is abnormal and worrisome due to seizure condition. Sore arm at injection site and general body aches present.
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| 72 | 2021-03-02 | insomnia |
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ...
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Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
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| 72 | 2021-03-03 | feeling abnormal |
i felt dizzy with my first vaccine on 2/5/21. ..it passed i started to feel dizzy/woozy/lightheaded,...
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i felt dizzy with my first vaccine on 2/5/21. ..it passed i started to feel dizzy/woozy/lightheaded, kind of seasick without the nausea almost 12 hours post 2nd vaccine. . this has continued now so far for 6 days. . it is more than brain fog.. it is a real sense of disequilibrium, like something is really affecting my brain. . . the base of my neck and spine have been incredibly tight and contracted with all the muscles in my head contracted. . this is more than a headache. .. i also seem to have the vaccine affecting my vision. . i know of 6 other people now that have similars symptoms and not all got pfizer
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| 72 | 2021-03-03 | feeling abnormal |
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ...
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2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
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| 72 | 2021-03-04 | sleep disorder |
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ...
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Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
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| 72 | 2021-03-06 | sleep disorder |
Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got bette...
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Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got better Saturday but then same symptoms returned Saturday night and continue today, joint pain, muscle pain
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| 72 | 2021-03-07 | feeling abnormal |
Days 1 and 2, 24 and 25 Feb 20201, severe interior cold, forced napping, lethargy. Day 6, 01Mar21, w...
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Days 1 and 2, 24 and 25 Feb 20201, severe interior cold, forced napping, lethargy. Day 6, 01Mar21, worked at computer for 15 minutes, became dizzy and with brain fog. Did the strain in my immune system rekindle symptoms from the April 2019 concussion? From then on, I used my sunglasses when working at computer. Day 8, 03 March 2021, resumed half of a mild weight-lifting routine. Days 9, 10 and 11, 4-6Mar 2021, forced napping, lethargy, some brain fog. This pattern, light exercise or chores followed by day(s) of lethargy and napping, closely resembles April through September 2020+plus as I recovered from what appeared to be COVID-19 in March 2020. The test at that time was negative. Day 12, Sunday I learned about this site. Today, Day 13, I'm a bit lethargic but OK, having done nothing since Friday. Haven't yet attempted any significant chore.
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| 72 | 2021-03-07 | mental status changes, confusional state |
Patient is a 72-year-old female presenting with fever and altered mental status. History is obtaine...
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Patient is a 72-year-old female presenting with fever and altered mental status. History is obtained for the patient and her husband. She got her second dose of Pfizer vaccine for Covid on 3/6/21. On 3/7/21, she woke with fever and urinary symptoms. She have an episode of incontinence and urinary frequency and urgency today. She was too weak to get up out of the recliner at home. She did have a fever this morning, which resolved with Tylenol. She also has been confused much lower mentally than normal. She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT. She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin, IV fluids, and tylenol.
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| 72 | 2021-03-09 | disorientation |
Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down ...
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Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down my arm all the way to my fingertips. Then I started to feel disoriented. Then, as I was driving myself home, I felt constriction in my chest, like I was barely holding onto consciousness, then pain shooting up my shoulder into the left side of my neck, the left side of my face, my left eye and into the left side of my head. My heart was pounding, my head was hurting intensely and I wondered whether I was having a stroke while trapped in stop and go traffic. The intense pain continued while I drove, for about 30 minutes. Then it subsided somewhat -- but continued through the evening. I could not get to The pain continued in my arm, up the left side of my body and into my head all night. I could not sleep. My heart was pounding. Somehow I dozed off around 2 or 3am. The next day I felt groggy and tired, with the more moderate pain continuing in my arm and all the way to my hand. Finally, on Monday morning, I was able to reach my doctor's office. I was told to go the ER, which I did. They could find nothing "emergent." The pain, tiredness and headaches continued through Thursday. Friday I started to feel better -- a week after the shot on Saturday, 2/27.
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| 72 | 2021-03-10 | hallucination |
Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; no...
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Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN
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| 72 | 2021-03-10 | excessive sleepiness |
slept for most of 2 days, no energy, achy all day, balance was off, shot site was sore, was not able...
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slept for most of 2 days, no energy, achy all day, balance was off, shot site was sore, was not able to lay on it or rub it
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| 72 | 2021-03-10 | sleep disorder, nightmare | Disturbing dreams with violence causing wakeup. Never experienced before. |
| 72 | 2021-03-12 | mental impairment |
I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner...
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I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner and until about 9 hours after the injection when my arm felt exceedingly sore. I had been watching a free Amazon Prime cute movie while knitting a blanket for my grandson. When the movie was over and I was clearing my knitting, I noticed my super sore arm. I got up to check my face in the mirror to be sure that I was not having a reaction. But I did have a reaction with a rash on my chest and face 9 hours after the injection. My arm really hurt for three days but is fine now. When I saw my red face and chest, I took a Zyrtex D and a Benadryl. It did not seem to help the redness to go away. When I felt some tightening of my throat and started to feel that I might be starting to lose some clarity of thought, I quickly watched a minute video on how to use my new kind of generic epipen and jabbed myself in the leg and called 911. I felt much better after the epipen in terms of my thinking and throat. Basically, the medics that came to the house and said that I had taken what they would give me at the hospital and it was up to me if I wanted to go to the emergency room or not; they would take me but I would need a ride home. With the pandemic and 48 new cases, I decided to stay home and I went to bed; the rash on my face was gone in the morning. The next days I just felt muscle soreness all through my body (day 2) and felt tired (next two days) but had no fever at any time. I am fine today. I appear to have two very small areas on my chest that probably related to the reaction.
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| 72 | 2021-03-12 | nervousness, irritability |
Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills....
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Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills. Felt very tired. Headache. Nurse checked oxygen level within 10 minutes and it was well above normal. Nurse put me in recliner and I slowly calmed down and felt sleepy. Left in one hour walking to car and driving home. These symptoms lasted 7 days. Very irritated for 7 days. Very uncomfortable.
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| 72 | 2021-03-14 | anxiety |
Client received her second dose of the Pfizer vaccine and during the post-vaccination wait time, she...
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Client received her second dose of the Pfizer vaccine and during the post-vaccination wait time, she complained of dizziness, and anxiety surrounding receiving the vaccine. Vital signs were as follows: Initial BP=163/93; Pulse=74; After 5 minutes, BP=171/101; Pulse=82; After 15minutes, BP=147/84; Pulse=75; Pulse Ox=96. On examination, client seemed to have difficulty breathing and she was visibly using her accessory muscles of respiration. She stated that the mask she had on made her claustrophobic and she stated that she did not want ?911? to be called and she did not want to go to the hospital. She waited for a while and stated that she felt well enough to go home. She was asked to call ?911? if her symptoms returned and she voiced understanding.
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| 72 | 2021-03-14 | feeling abnormal |
severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hur...
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severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that "Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic." No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.
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| 72 | 2021-03-14 | feeling abnormal |
burning sensation in lower back and both legs, dizziness, head fog, fatigue all lasted 24 hrs Have...
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burning sensation in lower back and both legs, dizziness, head fog, fatigue all lasted 24 hrs Have developed tinnitus with high pitch noise which seems to be in both ears.
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| 72 | 2021-03-14 | feeling abnormal |
States she has had mental fogginess and difficulty focusing since vaccine administration. Continues...
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States she has had mental fogginess and difficulty focusing since vaccine administration. Continues to the date of report (3/15/21)
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| 72 | 2021-03-14 | insomnia |
Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if...
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Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if stomach.
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| 72 | 2021-03-14 | nervousness, feeling abnormal | Headache, stiff neck, weak body, fuzzy thinking, shaky, unstable walking, metal taste in mouth. |
| 72 | 2021-03-15 | feeling abnormal |
I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv...
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I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
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| 72 | 2021-03-16 | feeling abnormal |
Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoi...
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Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoing in up and down cycles: chills,tight chest,foggy brain,bronchial cough with thick mucous ,some green, intense sneezing, nausea,diarrhea, Today,Wed March 17th very slow brain function low fever,diarrhea,very tired,hard to focus, less sneezing,no green mucous in cough.
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| 72 | 2021-03-17 | feeling abnormal |
Itching all over body, Foggy, eyes rollingback in head, unable to articulate information, fingers...
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Itching all over body, Foggy, eyes rollingback in head, unable to articulate information, fingers tingling.
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| 72 | 2021-03-17 | sleep disorder, impaired work ability |
The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea...
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The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea. These went on for the next week. I didn't go into work February 26th. But did go in partial days all the next week. Very uncomfortable. The headache got worse each day until it was very bad. On March 10th I woke up with my left arm in excruciating pain and the headache. Went to urgent care and doctor gave me a shot of Tromodol. When I got to the parking lot, I became very dizzy and my legs gave out and fell in the parking lot down to t he ground. Went to ER and waited for about 3.5 hours and left and went home. Went back to ER on March 12th due to arm in constant pain. Not able to sleep or relax. Wait this time was 3 hours and I was in too much paid so my daughter took me around the corner to urgent care. I was given steroid, muscle relaxer and a cream for my arm. My left arm from muscle up to shoulder and into wrist continues to hut. Today is 3/18/2021.
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| 72 | 2021-03-18 | feeling abnormal |
Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile...
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Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile walk Monday pm, missed meeting. Took 2 Tylenol, slept. Tues-Thurs: fatigue, chills, aches, diminished over the days. I rested and slept. Today=Friday, declared myself cured, took shorter walk, got tired, normally don?t get tired. *Today I discovered why I felt crooked: right shoulder higher because it?s swollen, down to mid-way between elbow & wrist, down to waist, some of side of body.* Treatment still only rest, but still I'm not so fatigued, aching easy to ignore. Never had fever (temp around 96.8 which is normal for me). I never felt too bad. Except for overpowering fatigue, I felt like doing things.
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| 72 | 2021-03-18 | panic attack | Panic attack 186/80, 128,98% 162/84, 96, 96% 156/78,94,98% |
| 72 | 2021-03-21 | mental status changes |
altered mental status, weakness, presyncopal. Evaluated by EMS-Transported to Emergency room/departm...
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altered mental status, weakness, presyncopal. Evaluated by EMS-Transported to Emergency room/department or urgent care.
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| 72 | 2021-03-22 | feeling abnormal |
Started with "Brain Fog" on day 2 after vaccine. Then by the next day had pressure in head with ear...
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Started with "Brain Fog" on day 2 after vaccine. Then by the next day had pressure in head with ear pain. Also, had some chills. Called doctor on day 4 but was not treated. On day 7 was started on an antibiotic which did help the pressure but did not help the ear pain and noise in ear. Better now but still has "noise in head" but states it is improving.
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| 72 | 2021-03-23 | sleep disorder |
She developed a swollen tongue within hours after the vaccine but woke her from sleep 16 hours post ...
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She developed a swollen tongue within hours after the vaccine but woke her from sleep 16 hours post vaccine with significant swollen tongue. Did not go to ER but called our office the next morning.
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| 72 | 2021-03-25 | anxiety, disturbance in attention |
About five days after vaccination ,I felt like I was having anxiety and apprehension. I don't normal...
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About five days after vaccination ,I felt like I was having anxiety and apprehension. I don't normally have anxiety. I was hearing weird sounds like crackling in my head. My concentration was not normal. Those symptoms lasted for several weeks. I went to see my doctor and he advised as long as it seemed to be improving, he would wait to consider treatment. It slowly got better, I had some good parts of some days. I finally felt normal six weeks out from the second dose of the vaccine.
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| 72 | 2021-03-25 | feeling abnormal |
"Pfizer-BioNT Covid-19Vaccine EUA" Because I am allergic to Hornet sings I waited 30 mins after the ...
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"Pfizer-BioNT Covid-19Vaccine EUA" Because I am allergic to Hornet sings I waited 30 mins after the injection. I was fine so I walked out to my truck. I became flushed in the face and my mouth had a metallic taste so I walked back into the clinic to tell them. They took my Blood pressure which was 200/125. I felt very off so they wheeled me into Urgent Care where they gave me one benadryl and monitored my blood pressure. They then called for ambulance for ER . I was released when my blood pressure was lower. I will not get the second injection of Pfizer!
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| 72 | 2021-03-25 | sleep disorder |
After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later...
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After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later, had 11 out of 12 days of migraine and after 8.5 days after shot had a whole body rash for 4.5 days . I have had vertigo most every day since the last shot on 2/20 and have had 27 migraines since the 1st shot Jan 30th I used Hydrocortisone on the itchy, blistery rash. Not much sleep for 3 nights. The night before the rash popped out I experienced chest pain that I thought was heartburn but was not relieved with baking soda and water and charcoal pills. It didn't go away until the hours into the next day and the rash was there at 3am. I have had Migraines for many years but this is 4 times more migraines.
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| 72 | 2021-03-26 | feeling abnormal | Brain Fog, extreme fatigue affecting my balance, muscle aches, loss of appetite, chills, fever |
| 72 | 2021-03-26 | hallucination |
Per pts husband, pt had been ? normal,? coking and even mowing the grass prior to receiving the covi...
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Per pts husband, pt had been ? normal,? coking and even mowing the grass prior to receiving the covid vaccine. She started to hallucinate and eventually was admitted to our facility and diagnosed with acute encephalopathy. The pt went home on hospice and has since passed Husband reports no one will listen to him regarding the events that took place.
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| 72 | 2021-03-26 | insomnia, sensation of foreign body |
Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both a...
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Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both arms. At 11 pm went to bed with large lump in my throat, felt like I was breathing thru a straw plus whole body freezing from inside out. Could not get warm. Added layers of clothes and blankets and laid like that all nite, no sleep. 7am called nurse, advised to remove some of the layers, drink hot liquids and Tylenol every four hours. By mid afternoon the cold was gone but severe achy bones, even the bottom of my feet hurt. Next day hot and cold and ache. Fourth day dripping sweat all day and flu like symptoms. Took three showers to get sweats down plus the entire time had been taking Tylenol every four hours. Day five just drained, felt like I'd been through the wringer.
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| 72 | 2021-03-28 | impaired work ability |
I have had muscle aches and headaches for three weeks after the first shot. had blood tests which ...
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I have had muscle aches and headaches for three weeks after the first shot. had blood tests which showed inflammation and was told it was okay to have the second shot. I now have the same muscle and headaches each day, levels between 5 and 8 out of 10, and the pain fluctuates each day. This will be my fifth week of these aches. I am on medical leave from work because the headache makes it hard for me to do my job.
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| 72 | 2021-03-30 | insomnia, feeling abnormal |
feeling dizzy like going to pass out; feeling dizzy like going to pass out; like I'm going crazy, li...
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feeling dizzy like going to pass out; feeling dizzy like going to pass out; like I'm going crazy, like I'm losing my mind; it is hard for her to sleep; severe headaches; ringing and "thump thump thump" in her head comes back; blood pressure goes up; chilly; had some sniffles; vision and her blood pressure and everything went up; This is a spontaneous report from a contactable consumer, reporting for herself. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200) via an unspecified route of administration, administered in the left arm on 01Mar202 (at the age of 72 years old) at a single dose for COVID-19 immunization. Vaccination was done in a baseball stadium. Vaccine was administered not administered military facility but firefighters and military were the ones giving the vaccine. Medical history included headaches from an unknown date and unknown if ongoing, ongoing cholesterol, ongoing seasonal allergies, ongoing sinus gets stopped up and high blood pressure and severe migraines (gets a shot every three months both from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for seasonal allergy and sinus gets stopped up/helps sinuses from Feb2021 and ongoing; lisinopril taken for high blood pressure and atorvastatin taken for cholesterol, both from an unspecified start date and ongoing. It was reported that the patient started taking lisinopril and atorvastatin years ago in her 50s. The patient experienced severe headaches, ringing and "thump thump thump" in her head comes back, blood pressure goes up, chilly, had some sniffles and vision and her blood pressure and everything went up on 02Mar2021, and feeling dizzy like going to pass out, like I'm going crazy, like I'm losing my mind and it is hard for her to sleep on an unspecified date. It was reported that the patient experienced severe headaches she's having was normal after receiving the Pfizer BioNTech COVID-19 vaccine on 01Mar2021 at around 13:00 or 14:00, appointment was between 13:00 and 15:00. She has had these headaches before but these were different since she had her vaccine. The patient stated severely when asked if she still has headaches. She sometimes takes a break from having the headaches, and she writes down medications she takes. Then, headaches will come back. It was not a long break, stated that the ringing and "thump thump thump" in her head comes back. She received her first dose and felt fine afterwards, had no side effects; and waited at the facility for 15 minutes. She left and got something to eat and came home after 4-5 hours. However, on the following Tuesday and Wednesday, the headaches started rolling in and have not stopped since. When she takes something for the headaches, her blood pressure goes up. She was feeling dizzy like she was going to pass out and like she was going crazy, like she was losing her mind. She has tried taking Tylenol and Ibuprofen but it seemed to aggravate it and says everything she takes make it worse. It was also reported that it was hard for her to sleep. She was concerned if she was in any kind of danger with these headaches and would like to know if there was any other medications she can take for it. It was also reported that on the second day, she was kind of chilly and had some sniffles and took a Zyrtec and said that her vision and her blood pressure and everything went up. She said that it seemed like if she takes a Tylenol or anything her blood pressure goes up. Her blood pressure only goes up if she takes something, she gets rush so bad and that blood pressure goes so high. When she feels this, she takes her blood pressure medication. She said that she thought maybe her headache would go away but has not gone away and she had another bad attack of a headache today and she took one of her medicines for headache, Butal-acet-caff 50-325-40 mg which did not make it worse. Also, tried Tylenol and Ibuprofen. She was trying everything all week but scared to take anything else because it brings a rush and feels like she's going to have a blackout. Took Tylenol at 10 o'clock last night, it seemed like she went crazy and it drove her nuts so she went and got high blood pressure medication so she could lay down. Took three Tylenol. She stated that somebody told her to take three, and that it was the worst mistake she made. Stated extra strength Tylenol. She wanted to know what advise she can get, with the virus going on she did not want to go to the emergency room. She also would like to know if it was recommended that she take the second dose of BNT162B2 vaccine following these severe headaches that she was experiencing after receiving her first dose. The patient underwent lab tests and procedures which included blood pressure: up on an unspecified date 2021 and magnetic resonance imaging: no brain damage or anything on 2020. The patient clarified the MRI was last year at some point before receiving vaccine. The outcome of the event severe headaches was not recovered while the outcome of all other events was unknown.
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| 72 | 2021-03-30 | sleep disorder |
Pt reports that apprx 1 hr after being vaccinated she had the following reactions: felt "an intense ...
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Pt reports that apprx 1 hr after being vaccinated she had the following reactions: felt "an intense heat t/o my body,all over"; Rash/hives on my hands, face & neck that lasted apprx 1/2 hr & then went away; fever; chills; nausea & "tickle in my throat. Pt reports these symptoms lasted t/o the night. Pt reports she did not sleep well.
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| 72 | 2021-04-03 | feeling abnormal |
affecting my brain; Couldn't articulate words clearly/thinking a particular word but would say a dif...
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affecting my brain; Couldn't articulate words clearly/thinking a particular word but would say a different one; stuttering; brain fog; feeling lightheaded and off balance; feeling lightheaded and off balance; pressure on my chest which made breathing slightly more labored; pressure on my chest which made breathing slightly more labored; pressure in my ears and throat; pressure in my ears and throat; my palms turned red; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 72-year-old, via an unspecified route of administration, administered in left arm on 01Mar2021 13:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included left bundle branch block, high cholesterol, and known allergies: intolerance to wheat, corn, peanuts, walnuts, sesame seeds. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient couldn't articulate words clearly due to stuttering. She would be thinking a particular word but would say a different one. This has subsided, but she was concerned as to whether she should take the second one as it's apparently affecting her brain. Also, mild symptoms of brain fog, feeling lightheaded and off balance, pressure on my chest which made breathing slightly more labored, pressure in my ears and throat, my palms turned red. All the events occurred on 01Mar2021 at 13:45. No treatment was received for the events. The outcome of the events couldn't articulate words clearly/thinking a particular word but would say a different one and stuttering was recovered on Mar2021 and recovering for the rest of the events.
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| 72 | 2021-04-04 | confusional state |
Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion,...
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Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion, inability to speak or find correct words for communication, sitting up on her own, incontinent episode x1, admitted to hospital for fever, vaccine reaction, discharged home
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| 72 | 2021-04-04 | feeling abnormal, delirium | Fever 102.8, chills, brain fog, aches, delirious |
| 72 | 2021-04-06 | feeling abnormal |
March 17, date of 2nd shot, a very minor sore arm for 3 days. Then I was fine. April 1 starting ...
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March 17, date of 2nd shot, a very minor sore arm for 3 days. Then I was fine. April 1 starting a little off, and woke up on April 2 dizzy when moving my head. April 3, I was worse and when I arrived to the kitchen, I spun out so dizzy, hit the floor. Hurt my hip, hands and knees, plus had a hard time getting up. Felt sea sick combined with Vertigo. I have been been dizzy ever since, when I get up to walk, or bend, or turn my head. This morning (April 7) when raising up off my pillow, I uncontrolledly, body slammed back onto the bed... typing this I am light headed.
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| 72 | 2021-04-10 | excessive sleepiness |
Received 1st Pfizer vaccine on 3/06/2021 since receiving shot she slept up to 12 hours a day. passed...
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Received 1st Pfizer vaccine on 3/06/2021 since receiving shot she slept up to 12 hours a day. passed away 9 days after receiving vaccination. She had no pre existing conditions.
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| 72 | 2021-04-11 | feeling abnormal, excessive sleepiness |
Shortly after the shot I began feeling sleepy. I slept most of the afternoon. I woke up about 10 o?c...
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Shortly after the shot I began feeling sleepy. I slept most of the afternoon. I woke up about 10 o?clock with a lot of pain in my back and shoulders. I was able to go back to sleep and woke up around around eight the next day. My body felt achy from my neck down. I mediately knew something was wrong. I was still sleeping through the morning. The pain throughout my body increased. I was very tired and again having a hell of a headache. The headache increased over the period of a few hours until it was unbearable. I took Tylenol often on to relieve the pain and about two in the afternoon I took my temperature and it was 101.6. I wasn?t too concerned as I?d heard a temperature was normal. However my headache and bodyaches continued to increase to the point where it was horrible. I began having chills and pulled several blankets over me about an hour later I took my temperature again and it was 103. I became concerned and called my doctors office. She advised me to take more Tylenol and put cold compresses on my forehead. And if I didn?t get better to go to the emergency. The cold compress on my forehead really helped me feel better. And shortly my temperature began to come down The pain in my head lightened up a little into the evening and I was able to sleep normally. The next day I still felt achy and tired and fatigued. However the extreme pain through my shoulders my neck and my head was mostly gone.
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| 72 | 2021-04-12 | excessive sleepiness |
Dizziness, rapid heart beat, loud heart beat, aware of heart beat, fatigue--sleeping 12 hours and w...
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Dizziness, rapid heart beat, loud heart beat, aware of heart beat, fatigue--sleeping 12 hours and waking tired, muscle soreness especially chest muscles, loss of appetite,
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| 72 | 2021-04-13 | disorientation |
Anaphylactoid: throat itching and swelling; loss of voice; nausea; diarrhea. Throat itching began w...
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Anaphylactoid: throat itching and swelling; loss of voice; nausea; diarrhea. Throat itching began within the first 5-6 minutes post vaccine; nurses in attendance gave me 25mg Benadryl within first 10 minutes and a second 25mg dose after the next 15 min...the diphenhydramine didn't take effect. The nurse took my BP and attached a device to monitor my oxygen level. After another 15 minutes, I felt disoriented, my voice became hoarse and I could barely talk...the nurse told me that my oxygen saturation was still good. I began to feel nauseated and had stomach cramps and bowel urgency. At that point, the nurse in attendance brought a wheelchair and took me to the ER, allowing me to stop to use the restroom. ER physician gave me famotidine 20mg and oral prednisone and watched me for 2+ hours. When I felt more oriented, they allowed me to go home. I did not require epinephrine, but the ER physican told me that I should NOT take the second dose. I followed up at home with Benadryl 25mg bid for 4 days. My voice returned in 6 days. I followed up my primary care physician, on Jan. 23rd...she also told me not to take the second dose. My primary care also advised me NOT to take the second dose. Please note: ran a basic blood panel as a part of my annual physical on Jan. 27th. The results came back with all my levels totally off the chart!! She had the test repeated on Feb. 16th and all my levels were back to normal. She noted that the discrepancy must have been a result of my reaction to the Pfizer vaccine and suggested that she would let her patients know NOT to have bloodwork done within 14 days of their COVID vaccine.
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| 72 | 2021-04-14 | panic reaction, anxiety |
Immediate warmth, dizziness, mild nausea, and progession to tunnel vision after her shot. She had a ...
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Immediate warmth, dizziness, mild nausea, and progession to tunnel vision after her shot. She had a sensation of rapid heart beat with a normal range pulse here in observation. She was very anxious and hesitant to come for the vaccine. BP was initially high for her, 162/87, with a pulse of 79. Normal O2 sats. BP improved with observation. Classic Anxiety/Panic symptoms with mild vasovagal symptoms. All resolved. patient to exit with wheelchair and staff
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| 72 | 2021-04-15 | confusional state | Extreme vomiting, unconscious state, confusion, loss of bladder , extreme pain on injection site arm |
| 72 | 2021-04-16 | disorientation |
From 2/12 had nausea, fatigue, disoriented, spinning in waves one or two times a day until 2/21. On...
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From 2/12 had nausea, fatigue, disoriented, spinning in waves one or two times a day until 2/21. On 2/21 had extreme vertigo, diarrhea, vomiting, couldn't sit up or walk. Called 911 at 10:45 am, hospitalized for 4 days.
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| 72 | 2021-04-20 | memory impairment, disturbance in attention, insomnia |
Heart flutter, fast heartbeat TIA symptoms: Headache, Vision issues-clouds in vision so couldn't re...
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Heart flutter, fast heartbeat TIA symptoms: Headache, Vision issues-clouds in vision so couldn't read what was trying to see, severe dizziness, very weak, felt faint as though would fall, walking difficulty and stumbling, dropping items, misapplied words, forgetfulness, couldn't remember words, forgetfulness, lack of concentration, migraine. Also terrible sinus issue with exorbitant mucus, insomnia
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| 72 | 2021-04-21 | excessive sleepiness |
Headache for 5 days Chills alternating with hot flashes for 5 days Extreme exhaustion for 5 days Sle...
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Headache for 5 days Chills alternating with hot flashes for 5 days Extreme exhaustion for 5 days Slept entire second day, only to eat and use facilities Body aches for 3 days No local reaction at injection site Diminished appetite for 4 days
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| 72 | 2021-04-23 | feeling abnormal |
Patient began slurring her words and then began laughing uncontrollably; Patient began slurring her ...
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Patient began slurring her words and then began laughing uncontrollably; Patient began slurring her words and then began laughing uncontrollably; headache; fogginess; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female (non pregnant) patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06Feb2021 11:45 (at the age of 72-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. No known allergies. Concomitant medication(s) included cyanocobalamin (VIT B12), duloxetine (DULOXETINE), gabapentin (GABAPENTIN) and losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. On 06Feb2021, 12:30, patient began slurring her words and then began laughing uncontrollably. Also had headache and fogginess. Event lasted about an hour at which point she took a nap. When she woke up she was feeling better. It was reported that there was no Covid prior to vaccination. The post vaccination patient had not tested Covid. Patient did not receive any treatment for adverse events. The outcome of events was recovered on an unspecified date in 2021. Information on the Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 72 | 2021-04-24 | feeling abnormal |
Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pai...
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Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pains; violently ill; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced vomiting and diarrhea. Mostly diarrhea. The vomiting started 05Mar2021 in the middle of the night. She was vomiting so much she went to the Emergency room by ambulance. They kept her in the hospital for a couple of days, but she did not have diarrhea at this time. It was like three days later that she suddenly became violently ill. At the time she did not tie it to the vaccine administration, she thought she had food poisoning or something. She then had severe diarrhea. She cannot recall the exact onset date of when the diarrhea began. She can't get the dates together because she knows she became very sick. Patient recalls that when she got out of the hospital, she was having stomach pains. The stomach pains were feeling more severe on 18Mar2021. On 19Mar2021, she went to a check up with her gynecologist for an annual check up and did tell her gynecologist about the stomach pain and having a lot of stomach issues, but the doctor had no idea about it, she's a gynecologist. The patient's gastroenterologist thought maybe she had diverticulitis not related to the Pfizer COVID-19 vaccine and on 27Mar2021, they started her on Cipro and Flagyl, but the diarrhea just kept getting worse even with the meds and its just been getting worse and worse and worse. Cipro and Flagyl were stopped after 5 days because her gastroenterologist told her that maybe all of her flora was cleared out, and the flora was causing the diarrhea. No one knows what was causing her diarrhea. Oddly enough, she was feeling a little better today. She feels like she doesn't have diarrhea today, but she doesn't know because sometimes she has diarrhea for a couple of hours and then she feels just fine for a couple of hours. She also has brain fog. She was feeling like she could not think straight. She confirmed she does not have this feeling today. It got really bad after the second shot. The brain fog started between the time of first and second shot, when she had the diarrhea. It was like a week to ten days after the first shot, but she does not know exactly when brain fog started. It comes and goes, doesn't have it right now, and didn't have it yesterday. She stated that the brain fog seems to have gone away about 5 days ago. She had all these blood tests and cat scan and they all came back negative that she is in perfect health. She has no other issue except this constant diarrhea. Caller states she doesn't have any issues with any of her abdominal organs, her gall bladder and intestines are all fine. She has lost 5 pounds explaining that a month ago she weighed 136 pounds and now she weighs 130 pounds. The diarrhea is without any known medical known ideology and is very debilitating because she has lost a lot of weight. The outcome of events was reported as "unknown". Follow-up attempts are completed. The following information on the batch number has been requested.
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| 72 | 2021-04-24 | insomnia |
Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racin...
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Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding; Arm barely sore; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 72-years-old , via an unspecified route of administration, administered in Arm Left on 31Mar2021 11:40 am as single dose for covid-19 immunisation. Medical history included ongoing food allergy, she had anaphylactic shock from a food allergy (she was 40 at the time and she doesn't eat anything she is allergic to), sinus infection and then got horrible hives under her eyes. No Prior Vaccinations (within 4 weeks). Concomitant medication was eye drops every night. No additional vaccines administered on same date of the Pfizer Suspect. The patient previously took epipen had two episodes when she was 40. She is bad about carrying her EpiPen, she forgets it. She was allergic to Amoxicillin. At 11:40 am last Wednesday patient had the vaccine, and around 4 or 5 pm, her heart started pounding for 10 seconds, and it felt like forever. An hour later, her heart started pounding again. It happened twice an hour apart and the second time lasted longer. It described as hard pounding. It started at 4 or 5 pm and then for 4.5 hours there was nothing, but then her heart started racing. At around 4 or 5 pm her heart was pounding, than around 9:30 pm her heart started racing and beating fast, she could feel it. She lives in a rural community and her husband called the local fire station and asked if he could take her there, to the station, so that she could have her heart checked. She was hooked up to a monitor and the paramedics said that she had an irregular arrhythmia and needed to go to the hospital by ambulance. Her heart rate was 115 to 130 beats, then 140 beats, at the hospital. It was about 11pm when she was evaluated and then left in the ambulance, as she was 45 minutes from the hospital. The paramedics would have, the arrhythmia, on record and that 5 minutes before she got to the hospital, the paramedic said her heart rhythm was normal. She was not admitted to the hospital, but held in observation and left the hospital at 4:30 in the morning. She hasn't felt anything after that. it was only one time she thought her heart was going faster, after that, but it didn't happen again. It is currently no problem and even at the hospital, the heart racing stopped and it was normal. The doctor in the emergency room said she was totally normal. Her arm was barely sore, when touched, and noticed this when she was being helped to the bathroom in the emergency room, maybe later in the afternoon, it was not hurting. But she didn't have any other events. She was tired the next day on 01Apr2021. She was up all night in the emergency room. people say that one will be tired, as an effect, but she can't say that it is because of the vaccine, or if she only had 3 hours of sleep. She hasn't been sleeping but she can't attribute it to the vaccine. She can't attribute this to the vaccine, that she has been tired lately and not sleeping. Event outcome of irregular arrhythmia and Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding was recovered on 31Mar2021, of Arm barely sore was recovered on 02Apr2021, of the remaining was unknown. Information about Batch/Lot number has been requested.
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| 72 | 2021-04-27 | disorientation |
Got up in middle of night to use bathroom and could not stand or walk, collapsed to the floor; Got u...
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Got up in middle of night to use bathroom and could not stand or walk, collapsed to the floor; Got up in middle of night to use bathroom and could not stand or walk, collapsed to the floor; Disoriented; I felt tired; achy; fever of 99.7; chills; severe muscle ache in leg and glute area; Could not move my leg; This is a spontaneous report from contactable consumer (Patient). A 72-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number/ Lot number: EN6201), via an unspecified route of administration on 13Feb2021 at 13:45 (at the age of 72-years) as a single dose for COVID-19 immunisation. Medical history included prior hemolytic anemia from 1989 and splenectomy from 2003. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included losartan at a dose of 50mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021, the patient felt tired, achy, and had fever of 99.7, chills, severe muscle ache in leg and glute area. The patient got up in middle of night to use bathroom and could not stand or walk, collapsed to the floor, disoriented, fell over. Her husband had to walk/carry her over to bed. The patient had severe pain in left leg and glute area, could not move her leg and this happened twice that night. The patient did not receive any treatment for the events. The outcome of all the events was recovering. Information on the lot/batch number has been requested.
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| 72 | 2021-04-27 | feeling abnormal, excessive sleepiness |
I am 72 year old female obesity, arthritis, diabetes, cancer survivor. I received Pfizer second dose...
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I am 72 year old female obesity, arthritis, diabetes, cancer survivor. I received Pfizer second dose and had the following side effects. Day of vaccine and day after, slept through for 48 hours. Day four I felt off, a bit dizzy. Day five my lower joints were weak, had trouble walking. Also at this time I experienced severe brain fog, everything was "graved out." It felt like I was drugged. I fell down and couldn't get up. EMT called to get me up. Still felt gray and wobbly so went back to bed. It took 10 days for all symptoms to resolve. The persistent sensation of being drugged was unique.
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| 72 | 2021-05-04 | feeling abnormal |
She picked at a little bump and it started to bleed; little bumps on her chest; sunburn; Chest top o...
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She picked at a little bump and it started to bleed; little bumps on her chest; sunburn; Chest top of shoulders, back of shoulders turned bright red/ Her chest, shoulder, and upper part of back turned red; She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut.; Nauseous; The inside of her body did not feel right. She felt like something was attacking the inside of her body.; sun allergy reaction; Rash on the top part of the chest; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 15:00 (Lot Number: EN6202) in the arm as SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took advil [ibuprofen], tylenol regular and vitamins. The patient went on a boat ride two weeks later with minimal exposure to the sun and developed chest, top of shoulders, back of shoulders turned bright red. She put after sun lotion on and it didn't go away. She was told by her pharmacist to take bendryl and use cortisone with aloe. She used topical benadryl gel first and it wasn't helpful. She took oral liquid benadryl and was able to sleep. The patient stated, It felt like "I had an open wound and poured peroxide on it- my entire chest." She couldn't stand to have clothes on her chest. She did not develop any blisters. Her doctor recommended she not get the second dose so she missed the second dose. She believes that she had a reaction to the covid vaccine. She received the first dose of the covid vaccine, and the inside of her body did not feel right. She felt like something was attacking the inside of her body. A couple of weeks later, she went on a boat ride with her friends. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut. She tried treating it with aloe vera and a cloth with cold water. Hydrocortisone 1% with aloe vera made it hurt worse. She took liquid Benadryl and it put her to sleep. She has been reading up on side effects and about people calling to report. She thinks that she had a sun allergy reaction. The redness has still has not gone away. She now has little bumps on her chest. She is going to go to the dermatologist. She thinks that she had this reaction from the covid vaccine. She is 72 years old. She has never had anything happen to her like this before. She is out in the sun often. The day that she took the boat ride, she was only out for a little period. It goes from the upper part of her breast to her shoulder. She is not allergic to the sun, so she is not sure why she had a reaction. Because sun allergies are common, but not often reported, she wanted to call and report about her experience. The inside of her body did not feel right. She felt like something was attacking the inside of her body. It began on the same day she received the covid vaccine, 17Mar2021. It is now recovered completely. It lasted for several weeks, at least two weeks. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut: She clarifies that it is like a redness, like a sunburn. It began on 31Mar2021, two weeks after she received the first dose of the covid vaccine. It is a lot better now. But now she has these little bumps, she picked at a little bump and it started to bleed. She is asking about sun allergies. She is asking what can she do about this. She is asking if she can take anything. Hydrocortisone 1% with aloe vera made it hurt worse. She also used After Tan that had aloe vera in it. After Tan is a lotion made by Banana Boat that is sold over the counter. It is raining cats and dogs outside, so she is not able to go and get the bottle. She took liquid Benadryl and it put her to sleep. Benadryl gel made her skin burn. The patient had rash on the top part of the chest in Mar2021. The outcome of the event did not feel right, shoulders turned bright red and skin feeling like she poured peroxide on an open wound and nauseous was recovering. The outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 72 | 2021-05-24 | confusional state |
WEAKNESS TO THE POINT OF HAVING PROBLEMS WITH AMBULATION, UNABLE TO CLIMB STAIRS, AND CONFUSION TH...
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WEAKNESS TO THE POINT OF HAVING PROBLEMS WITH AMBULATION, UNABLE TO CLIMB STAIRS, AND CONFUSION THAT ENDED WITH HOSPITALIZATION MAY 1, 2021 NASAL AND RECTAL BLEEDING. LOW PLATLETS, FLUID ON THE BRAIN A SEVERE COGINATIVE IMPAIRMENT.
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| 72 | 2021-05-24 | confusional state |
3/9 MHN, admitted day after covid vaccine with weakness/SOB. Patient with history of small cell lung...
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3/9 MHN, admitted day after covid vaccine with weakness/SOB. Patient with history of small cell lung cancer metastatic on chemotherapy, COPD, diabetes, Sjogren's who presents with shortness of breath, confusion, and generalized fatigue as well as fall 1 week ago found to have recurrent pleural effusion, T7 fracture, new metastases, UTI. Shortness of breath: Suspicion is that this is related to malignancy plus effusion. Shortness of breath markedly improved after removal of Transudative fluid, 470cc obtained on thora 3/10 with cytology negative. Encephalopathy: Daughter notes that she has been more confused. The patient is off on her timeline of details. CT shows no evidence of brain metastases nor does recent MRI. Chronic hypoxemic respiratory failure: Patient is on 3 L of oxygen at baseline and she is currently at baseline. Generalized weakness: Her neuro exam is nonfocal aside from her confusion of timeline. CT and MRI have been unremarkable. I discussed her T7 fracture with spine surgery who recommends CT of entire spine which showed additional metastases. Patient has no pain and has declined the need for brace. Metastatic small cell lung cancer: Patient admits that she does not like to talk much about the big picture however her daughter at bedside did speak with me outside the room and understands that she may have a poor prognosis. UTI: With increased frequency/urgency/incontinence. There is trace leuk esterase on UA. She has been on ceftriaxone but urine culture showing 80,000 colonies of Enterococcus. Changed to vancomycin. I discussed with the microbiology lab who stated that sensitivities would not be available until 3/13. Discharged with sensitivities pending initially with plan for amoxicillin but given interaction with methotrexate change to Macrobid. Normocytic anemia: Likely related to malignancy and chemotherapy. No blood loss has been noted. She received 1 unit RBCs prior to discharge.
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| 72 | 2021-05-24 | loss of personal independence in daily activities |
Several weeks after my 2nd Pfizer Covid-19 vaccination I developed fingernail irregularities on my r...
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Several weeks after my 2nd Pfizer Covid-19 vaccination I developed fingernail irregularities on my right hand, later diagnosed as Beau's lines. I do not remember the specific date this appeared. It started with purple/red color on four fingernails in the half moon area. Later turned white and one nail came off, with another growing underneath. At some point the Beau's lines appeared. By the time I got an appointment with my dermatologist, at the suggestion of my primary care doctor, for diagnosis, significant time had gone by. Around the same time after the vaccine, I developed very painful headaches we are attributing to tight neck muscles, but I have never been a headache person before and these headaches are very debilitating and unlike any headache I have ever experienced, even though I have not been a frequent headache sufferer . I understand that Beau's lines have been associated with Covid iteslf, but I highly doubt I had Covid itself. I have had, in the past, very very rare side effects to medications and I have broken out in hives from the pneumonia vaccine I had had before, several years ago.
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| 72 | 2021-06-03 | confusional state, delirium, disorientation |
Patient became disoriented with time (Dementia symptoms). Went into kidney failure and was admited i...
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Patient became disoriented with time (Dementia symptoms). Went into kidney failure and was admited into the hospital with mental confusion (dilerium).
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| 72 | 2021-06-03 | feeling abnormal |
Completely blacked out; heart unstable; Light headedness; On Monday she did not feel herself. She fe...
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Completely blacked out; heart unstable; Light headedness; On Monday she did not feel herself. She felt bad,; tingling in hands, legs, and ankles; left hip was super sore; glands in neck were aching; Body aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 (Lot Number: EW0172) as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EW0162, left arm, on 13Apr2021 for Covid-19 immunization. The patient experienced completely blacked out on 18May2021 with outcome of unknown, body aches on 14May2021 with outcome of unknown, chills on 14May2021 with outcome of unknown, tingling in hands, legs, and ankles on 15May2021 with outcome of recovering, left hip was super sore on 15May2021 with outcome of recovering, glands in neck were aching on 15May2021 with outcome of unknown, heart unstable on 18May2021 with outcome of unknown, light headedness on 18May2021 with outcome of unknown, on Monday she did not feel herself. she felt bad, on 18May2021 with outcome of unknown. She received treatment for event heart unstable. Clinical course: Caller called after her first dose of the COVID vaccine because she had a question about a heart test she needed to have done and was it safe. She also had called about side effects she had from the first vaccine. She wanted to follow up with the second vaccine because she had some unusual problems with it. She got the vaccine. She did not have a prescribing doctor. She went to University . She asked questions from side effects after the first one. Caller doesn't have a reference number. She was reluctant to get the second knowing how sensitive she was to the first dose. She worked with her heart doctor after the symptoms she had after first dose which were heart related. They beefed up her heart medications for the second one. She is very sensitive to medications and vaccines in the past. She was in shock. With the second shot, everything was fine on the first day. That night she was fine as well. She got the shot Thursday 13 May 2021.On Friday she was pretty okay. She did have body aches and chills. On Saturday 15 May 2021, she had tingling in her hands, legs, and ankles. Her left hip was super sore enough that she couldn't stand on it. The glands in her neck were aching. They beefed up her heart medication, but her heart was beating like crazy. On day 3, Sunday, she was still having weird tingling and heart stayed stable. On Monday she did not feel herself. She felt bad but went to work. At that point she was not happy she took the COVID vaccine. Tuesday, 18 May 2021, her heart was really unstable. She was lightheaded. Her heart was beating back and forth extra hard. She had a hard time getting ready for work. She took readings on her apple watch. She went to leave for work but couldn't find her keys. She decided she would be fine. She was standing at her door trying to set the alarm when she woke up on the floor in the kitchen. She had blacked out in the kitchen. She came too on the floor, and her heart was going back and forth. Her heart doctor said don't go to the hospital. He thought it was a combination between the stress of the vaccine, and her extra heart medication. She is seeing her heart doctor today for follow up. This is the first time she has ever just completely blacked out. Her symptoms are ongoing, but much improved. She can finally stand now. She had body aches in specific places. There was nothing wrong in her left hip normally. The tingling in her hands has went away, but it is still in her knees and feet. It feels like she has neuropathy. It has improved but is bothersome. She is glad it is not seeming to be an ongoing thing. Second dose on 13May2021, She waited a week due to side effects from the first one because she was pretty sick. Most of the symptoms were on the left side of her body. She had numbness and tingling in her hands and feet. The passing out was not good. She was super disoriented . She didn't know if she hit her head or not. She is very sore. Her friend came over. Her shoulder and arm are bruised. The doctor said with COVID going on not to go to the ER. The doctor stayed in touch with her on Tuesday, and said he would see her Thursday morning, Today. She thinks she is okay. It was just a combination of everything. With the first vaccine she had arrhythmias and Afib for 3 days. The doctor said he read that multiple patients from all the different COVID vaccine have experienced a flare up in their arrhythmias.
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| 72 | 2021-06-03 | feeling abnormal |
On the third day after the injection, I had a sudden return of sx previously experienced with medic...
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On the third day after the injection, I had a sudden return of sx previously experienced with medications cleared 3A4/5 and 2C19 including rigid paralysis for >11 minutes, multiple contractions, numbness/tingling in legs. I had not experienced any of these symptoms for > 3 months. Also fibromyalgia sx exacerbated to include burning pain in L arm (injection site) For 1 week, my arm turned red, like sunburn and burned. After week 1, there was no redness but there was more pain than burning and that continued for about 4 weeks. This has since abated. I currently have extreme fatigue, fibromyalgia pain in multiple sites, esp breast, chest and legs. Numbness and tingling continues in my feet and legs. I am also experiencing transient numbness in my lower face, periods of severe "brain fog" (this seems to be improving) and GERD sx relieved by antacids.
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| 72 | 2021-06-03 | sleep disorder | woke up sweating, clothes wet; did not feel sick; changed clothes and went back to bed |
| 72 | 2021-06-04 | feeling abnormal |
Injected me pretty high up on my shoulder that was a lot of pain; have a black and blue mark about a...
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Injected me pretty high up on my shoulder that was a lot of pain; have a black and blue mark about a size of a quarter, up there the shot site; I didn't get a full does of second vaccine; felt bad; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient herself). A 72-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 04Mar2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 09Feb2021 (at the age of 72-year-old). Relevant medical history included low immunity. Concomitant medications were not reported. On an unknown date the patient experienced "injected me pretty high up on my shoulder that was a lot of pain then I felt a lot of cold fluid running down on my arm instead of getting in my body, was really cold like quite away after that wiped" (as reported), black and blue mark about a size of a quarter, up there the shot site, she didn't get a full does of second vaccine and felt bad. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 72 | 2021-06-07 | loss of personal independence in daily activities |
I woke up in the night with a fungus infection of the urinary, vaginal, pubic mound, and anal area. ...
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I woke up in the night with a fungus infection of the urinary, vaginal, pubic mound, and anal area. I was in extreme pain and called Dr first thing Monday morning for an emergency appt. she prescribed diflucan and a fungal cream. The fungus persisted for 6 1/2 weeks rendering me incapable of caring for myself. The fungus was treated by her with 4 different fungal creams . One of which include a steroid. The final cream was a compounded cream. I saw here 3 times in the office and spoke with here once on the phone on April 10th. I have just had my 6 month well visit with Dr. my GP today and he advised I should contact the Clinic and report my adverse reaction. He is an infection disease specialist.
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| 72 | 2021-06-08 | delirium |
Tested positive for Covid/Pneumonia; Bruised all over; Veins collapsed; Tested positive for Covid; S...
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Tested positive for Covid/Pneumonia; Bruised all over; Veins collapsed; Tested positive for Covid; She was incredibly ill.; Weak; Pain in the back; Delirious; Second dose: a little tired; second dose: a little redness and swelling at the site; Second dose: a little redness and swelling at the site; This is a spontaneous report received from a contactable consumer (Patient). A 72-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 (Batch/Lot Number: EL9269; Expiration Date: May2021) as first dose single dose, via an unspecified route of administration, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EL8982; Expiration Date: May2021) as 1st dose single for covid-19 immunisation. Medical history included ongoing glaucoma, ongoing blood cholesterol increased overweight. The patient's concomitant medications included statin, blood pressure medication and eye drops. Patient historic vaccine included 2 Shingrix vaccine received on an unspecified date in 2018 for Shingles and experienced arm sore, arm redness, and had swelling. A little more redness and swelling than the Covid vaccine. Has no NDC/LOT/Exp to provide. On an unspecified date in Apr2021, Patient was tested positive for covid and experienced pneumonia with symptoms of fever, chest tightness and shortness of breathing, also experienced delirious and weak, on12Feb2021, he had a little redness and swelling at the site, on an unspecified date he had pain in the back, bruised all over and on 20Apr2021, she was incredibly ill. Patient received her second Pfizer Covid vaccine on 11Feb2021. She went to the hospital on 20Apr2021 and tested positive for Covid. She was in the hospital from 20Apr2021 to 27Apr2021. She also had pneumonia and was still on oxygen. She received her first dose of the Pfizer Covid vaccine in 21Jan2021. She reported being incredibly ill on 20Apr2021 and shocked at how sick she was. Knows with any vaccine, like child vaccinations, it was possible to get mild cases. She was in really bad shape with pneumonia in both lungs and in the hospital for a week, in isolation. She came home rather weak with home health care. She came home on oxygen and was now finally able to get off of oxygen to do things. She was also under quarantine and had to have two more Covid tests. A little redness and swelling at the site for a day or two. It was gone by the 15Feb2021 or 16Feb2021, it didn't last long. Recovered completely. She later stated this ended on 13Feb2021. She reported having symptoms of a cold, that she started getting a fever and then went for a Covid test at a (withheld). She found out two days later that she had Covid. She stated it worsened. She stayed home and rested, and her fever kept growing, then her chest started to hurt. She talked to her doctor on 20Apr2021 and was told to go to the hospital. She called an ambulance and went. She stated on 15Apr2021, she went to a walk-in clinic for an x-ray of her lungs and at that point they were still pretty good. That was on Thursday and over the weekend, that was when she needed to go to the Emergency Room. She added that she also had trouble breathing, had an IV, and was delirious. She was tired for a day and that was it. Then resumed all normal activities. Recovered with no effects from the vaccines. Caller stated she resumed everything by 15Feb2021. Knew she had a fever, was really hot but did not have a thermometer. She said when the fever started coming on stronger, she was not cognizant of everything that was happening. Thinks her temperature in the hospital was normal after a couple of days. Tested positive for Covid around 15Apr2021 or 16Apr2021. Started hurting 16Apr2021 or 17Apr2021. The pain was more in her back. She had difficulty breathing and pain in the back. Both of those probably didn't stop until she got discharged from the hospital. She also reported having pneumonia in both her lungs. She was taking a statin, a blood pressure medication, and eye drops. Had glaucoma and high cholesterol. A CAT scan of her lungs was performed because of the pneumonia. Had daily blood work. Tested positive for Covid: tested positive around 15Apr2021 or 16Apr2021. She had IVs with antibiotics and Remdesivir. She was in bad shape. It was a little touch and go for a while there. Had one dose each day IV of Remdesivir for five days. She was on oxygen but not on a ventilator while in the hospital and continued while came home, still on oxygen, dose was lower but still on it. Has no NDC/LOT/Exp to provide for Remdesivir. Her Veins collapsed; they couldn't find any way to get blood. She had a problem with her IV, had to call an EMT person to find another vein. She was incredibly ill. She hasn't been in hospital since daughter was born 45 years ago. For the first few days she was really ill and was in very serious condition. Was black and blue all over from all the shots. Was being given shots in her stomach. They were doing things in her arm. She was very fair and just bruised all over. Everything was healed. She was getting lots of needles. She said she didn't have any adverse reaction to the injection. Her concern was that she could have died from the pneumonia. The focus needs to be on how sick she was since the vaccine was supposed to protect her. How could she have gotten that ill? She can only do very little. Taking her a long time to get out on her feet. She can't function to write the math books and was missing deadlines. Cannot do more than a few things and it was taking her a while. Her being positive for Covid should have been a mild case. It was taking her a long time to recover. She had friends and acquaintances that got Covid and were home for a couple of days and tested negative. No further details provided. Wouldn't had expected the double pneumonia and being seriously ill. Since the Remdesivir, she now had scarring on her liver. Is disappointed, felt like she was being treated like a piece of data and like a lab rat, but a human being was involved. She could have died from pneumonia. Was concerned how she got so sick. Wanted to know if this had been reported with other people. Was still home recovering a month later, not functioning as well as she should be. Thought she would be protected. Stated Pfizer should be more concerned with her illness than the vaccine. Had this happened to anyone else? She shouldn't have been that sick. The patient underwent lab tests and procedures which included blood test: result unknown and had daily blood work, computerized tomogram: result unknown of her lungs was performed because of the pneumonia, sars-cov-2 test: positive on Apr2021 and x-ray: normal on 15Apr2021 x-ray of her lungs and at that point they were still pretty good. Remdesivir was administered as a therapeutic measure to treat the adverse event. The outcome of event Delirious, tested covid positive, weak, back pain, incredibly ill, Veins collapsed was unknown, fatigue was recovered on 15Feb2021, a little redness and swelling at the site was recovered on 13Feb2021 and bruised all over was recovered on an unknown date. Follow-up attempts are needed. Further information is expected.
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| 72 | 2021-06-08 | sleep disorder |
Two days after receiving my first dose I began having migraine headaches every day. Although I have...
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Two days after receiving my first dose I began having migraine headaches every day. Although I have a history of migraines, I rarely get one nowadays. Maybe one every few months. Anyway, the headaches went on for two weeks then stopped. I really want to report what happened after my second shot (on March 22). Can I do that here? If I can, here is what has happened. After my second shot I noticed a little pain in my neck. I didn't worry too much about it until May 5, when suddenly the pain was so bad I coudn't sleep. I have struggled with the pain ever since then, but it has gotten better. I've been to a chiropractor and medical doctor. Was given adjustments (which helped) and drugs, mostly I took just the Tylenol and a few muscle relaxers. I cannot take Ibuprophen due to my kidney disease, which is a real shame. I know they would have helped. I have pain when I try to move my head in certain ways. The pain is in the left side of my neck, and seems to be a muscle that is inflamed. I also began experiencing pain in my right shoulder at the same time. Hurts when I try to lift my arm. That is better now, also.
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| 72 | 2021-06-09 | anxiety |
feet restless and jittery; feet restless and jittery; Increased high anxiety, difficulty calming dow...
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feet restless and jittery; feet restless and jittery; Increased high anxiety, difficulty calming down; legs jittery/feet jittery; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 13Mar2021 at 14:30 (at 72 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included diabetic, hypothyroid, high blood pressure, gastroesophageal reflux disease (GERD), chronic kidney disease, and restless legs; all from unspecified date. Concomitant medications included dioxybenzone/padimate o (SUNGARD) 12.5 mg x2/day and glimepiride 2 mg x2/day, both from unspecified date for unspecified indication. It was unknown if the patent had COVID prior to vaccination. The patient was tested for COVID post vaccination (results unknown). The patient increased high anxiety, legs jittery, feet restless and jittery. The patient had difficulty calming down. All events were non-serious on 13Mar2021 at 17:00. The patient took muscle relaxant, tizanidine 4 mg, but had very little help. No treatment received for other events. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch no cannot be obtained.
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| 72 | 2021-06-09 | insomnia |
red rash on my inner thighs; pain in the injection site; couldn't go back to sleep; chills; my throa...
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red rash on my inner thighs; pain in the injection site; couldn't go back to sleep; chills; my throat hurt; tired; muscle pain; my arm hurt; pain in my shoulder is much improved though; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non pregnant female patient received second dose of BNT162B2 (Solution for injection, lot number: EN6199 expiry date: unknown) via an unspecified route of administration in Right arm on 08Mar2021 10:45 as a single dose for Covid-19 immunization. Medical history included high blood pressure and cholesterol, she had diverticulosis, but it was not active at the time of this report. She did not have any known allergies. Concomitant medications in two weeks included Amlodepine, Rosuvastatin and unspecified prescription medicine for high blood pressure and cholesterol. The patient previously received first dose of BNT162B2 (Solution for injection, lot number: EN6201 expiry date: unknown) via an unspecified route of administration in Left arm on 15Feb2021 14:00, as a single dose for Covid-19 immunization. The patient did not receive any other vac-cine in four weeks of suspect vaccine. It was stated that the first shot caused soreness in her arm where the injection was made, which went away after about three days. After about 10 days, she developed a rash on both inner thighs. It cleared up in about three days. The patient also had a rash on the left side of face about the same time. She received second shot two days prior to this report, on 08Mar2021, the day of vaccination, the patient experienced that her arm hurt, and she woke up about 4:30 am and could not go back to sleep because it hurt so. She had chills that day, her throat hurt, she felt so tired, and had muscle pain. On 10Mar2021 the day of this report, two days after the shot, she had the red rash on inner thighs again, but the other symptoms (except for the pain in the injection site) were gone. The pain in her shoulder was much improved though. She did take one acetaminophen a day prior to this report in afternoon. The patient did not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of the events of was resolving. No follow-up attempts were Possible. No further information was expected.
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| 72 | 2021-06-10 | feeling abnormal |
she experienced her arm was itching all up and down, not on the side where she took the shot, the ot...
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she experienced her arm was itching all up and down, not on the side where she took the shot, the other arm the other arm It's really bad, it's like under your skin it's itching; I was rubbing my arm and I broke out in little welt, I broke out with the welt on each arm.; Sick of the discomfort I am having because I am itching; Sick of the discomfort I am having because I am itching; I don't know what's happening with me and I didn't like feeling I feel with this side effects. So, that's what I am trying to figure out; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0185) via an unspecified route of administration on 03Jun2021 at 09:00 (at the age of 72 years) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Jun2021, patient took the COVID shot morning about 9 O'clock and just a minute ago right after the vaccination, her arm was itching all up and down, not on the side where she took the shot, the other arm. Well at both of them at the bottom, she was rubbing her arm and broke out in little welt on each arm. And it's real bad, it's like under the skin its itching. Patient was really trying to find out about her arm as she was sick of the discomfort she was having because of itching. Patient enquired that she does not know what's happening with her and she didn't like feeling she felt with this side effects. Patient just wanted to know what was wrong, why she was having side effects, why does she have to go through all of that. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 72 | 2021-06-10 | feeling abnormal |
she was having an anaphylactic reaction; feeling so bad; It was pained all over; she got a woozy aft...
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she was having an anaphylactic reaction; feeling so bad; It was pained all over; she got a woozy after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing diabetes, ongoing blood pressure high, coronary artery disease, spinal stenosis, arthritis, Penicillin allergy (doesn't have the product that was back in 1969, Drug hypersensitivity), bee sting, shrimp, ongoing cholesterol, ongoing hypertension. Concomitant medication included insulin aspart (NOVOLOG) taken for diabetes; insulin detemir (LEVEMIR) taken for diabetes, candesartan taken for hypertension; nifedipine (PROCARDIA [NIFEDIPINE]) taken for hypertension; carvedilol taken for hypertension; rosuvastatin calcium (CRESTOR) taken for cholesterol; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took epipen for stung by a bee (stuck that EpiPen in her thigh). The patient experienced she was having an anaphylactic reaction, feeling so bad on 17Feb2021, she got a woozy after the vaccine and it was pained all over on 16Feb2021. Patient stated she received the first dose of the vaccine on 16Feb2021. Caller states she had a severe reaction so dramatic that she has decided that she is not going to take the second dose of the vaccine. When she went in they asked if she had an allergy. She said bee sting, Penicillin, and shrimp. They responded and told her if she had a reaction they had an EpiPen there for her. She has not had an EpiPen injection since 1987. She did not remember what it was like. Back in 1987, she got stung by a bee. She felt so bad. She felt that if she closed her eyes she would die. Her daughter called 911 and they came, but they did not have the EpiPen. Her son called her family doctor who came over with the EpiPen. He said she was having a severe reaction to the bee sting. He saved her life. When she went in on Tuesday she got a woozy after the vaccine. It was not near as bad as what she experienced in 1987. She stayed there 45 minutes and they brought her water and a bagel. She drank the water but did not eat the bagel. She went home and was fine all night. The next morning about 8AM, she started feeling so bad. She felt worse than she did in 1987. She felt like she was going to die if she closed her eye. It did not dawn on her that she was having an anaphylactic reaction. Her friend sent her a text that had four versions of a scripture. The scripture said has different plans for her. She read that to herself and started to feel better. She attributed it to saving her life. She told her cardiologist she is 72 years old and has underlying conditions and she does not want to go through that again. In 1987 the doctor came in the house and the fireman was already there. The doctor came over to her and he just stuck that EpiPen in her thigh. Everything in the body went to the top of her head. She felt like if she could open her head she could let the pain and everything out. Feeling so bad: It lasted for about 15 to 30 minutes. Then caller clarified her friend texted her at 9:26AM, so it may have lasted an hour to an hour and a half. She ached all over. Her body felt dead. It was pained all over. Everything was trapped inside her head. She went to the cardiologist and all her numbers were fine. She told him she was not going to take another shot. She is going to go back for a stress test because she has been diagnosed with coronary artery disease. She has an appointment with her primary care doctor, on 10Mar2021 and will see what he has to say. Time the Vaccination Was Given: her appointment was at 11:30AM. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The adverse events require a visit to Physician Office, She felt better and decided not to take the other shot. She ran it by her doctors. She has an appointment. She has not cancelled it yet. She wants to find out what the ramifications would be if she did not take the second one. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations: She does not have a spleen. She has had her flu shot. She has not had the shingles vaccination. It is not time for Pneumovax. She keeps up and follows her doctors. The patient underwent lab tests and procedures which included numbers: unknown results. The outcome of the events was unknown.
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| 73 | 2021-01-05 | anxiety |
During the patient's 15 minute post COVID vaccine observation, she reported feeling dizzy and unstea...
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During the patient's 15 minute post COVID vaccine observation, she reported feeling dizzy and unsteady on her feet. Her BP 188/78. HR 98. Pulse Ox 98% on room air. She did state she was anxious about recieving vaccine. While obtaining health history, the patient revealed she was feelin dizzy and unsteady as she was exiting the car this morning. She did not eat breakfast and also recently started allergy shots. She had skipped her allergy shot this week because of this appointment for COVID vaccine. Patient was monitored for an aditional 30 minutes. Vital signs returned to normal but she was still feeling dizzy. Her husband was called to pick her upand she was instructed to follow up with PCP.
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| 73 | 2021-01-06 | anxiety |
Husband verbalized that wife was very anxious about the process and vaccination and after receiving ...
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Husband verbalized that wife was very anxious about the process and vaccination and after receiving the vaccine she was texting and reading while he was driving and she felt dizzy, She was evaluated by Rescue and at 1:35 pm was released to her home feeling good.
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| 73 | 2021-01-20 | feeling abnormal |
weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two...
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weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two on right chin, slight breathing issue, slight numbness on sides of tongue and between bottom of nose and top of lips,
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| 73 | 2021-01-20 | nervousness |
At 10:47 am client complained of nervousness and heart palpation. Client was attended by onsite EMS...
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At 10:47 am client complained of nervousness and heart palpation. Client was attended by onsite EMS and released home after stating she felt better.
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| 73 | 2021-01-21 | loss of personal independence in daily activities |
72 hrs after injection...unbearable pain from sight to the top of the shoulder similar to rotator cu...
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72 hrs after injection...unbearable pain from sight to the top of the shoulder similar to rotator cuff pain. it eased up with continuous throbbing. Then 72 hrs later on Jan.14 same extreme pain as if I had rotator cuff surgery without anesthesia, Then the rest of the days continual throbbing especially in the shoulder area. Using Advil and hot compresses. I am limited as to completely using my arm. I have been unable to work at my daily life.
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| 73 | 2021-01-25 | nervousness | Within 15-minutes of vaccination, the patient stated she began feeling "nervous and shaky". |
| 73 | 2021-01-26 | disorientation |
Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood press...
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Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood pressure was 198/91. Per clinical nursing director, EMS called. EMS checked vitals again and blood pressure was 130/82. At that time EMS and patient decided that patient did not need to be transported to hospital at this time. Patient left with husband. At time of departure patient was oriented and reported feeling well.
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| 73 | 2021-01-27 | insomnia |
Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely ...
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Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely sore. Joint pain increased, involving shoulders, hands, legs, arms, knees and hips. Left hand began swelling on January 23rd and continued so I could no longer see my knuckles and it ballooned and it was hot and very painful. The knees were so bad it was almost impossible to stand from a sitting position and walking was stiff. Could not sleep laying down because pain in shoulders and knees would increase. I went to the doctor on the 26th. he prescribed Prednisolone for one week and I am scheduled to see him next Tuesday February 2nd.
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| 73 | 2021-01-28 | anxiety |
12-minutes after vaccination, the patient reported feeling lightheaded and dizzy. Patient was noted ...
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12-minutes after vaccination, the patient reported feeling lightheaded and dizzy. Patient was noted to be anxious and hypertensive. EMS managed care on-site and patient refused transport to hospital. Noted to be feeling improved prior to leaving facility.
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| 73 | 2021-01-31 | anxiety, nervousness |
Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjectiv...
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Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness, sweating, and feeling flushed She denied hives, loss of sensation, SOB. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling. ALLERGY REVIEW OF SYSTEMS Previous Reactions: PCN Objective Vitals Vitals: 01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99% Blood Sugar 97 collected at 1500 Physical Exam No Rashes or Hives noted. No facial swelling , no wheezes. HEENT Pharynx is clear without exduate. No facial or tongue swelling. Lungs CTA all wheeze No SOB. Neck is supple. No swelling is noted. pt is anxious and nervous. No sign of anaphalyxis No stridor, no swelling Assessment/Plan Treatment included: antihistamines Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Mild reaction, improving. Pt refused any further medications or assessment at the ER. Her husband will pick her up.
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| 73 | 2021-01-31 | feeling abnormal |
Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she c...
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Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she can't really describe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: SL3246), via an unspecified route of administration in right arm, on 12Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took varicella zoster vaccine (SHINGLES VACCINE) for immunization and had a little reaction but just the normal things. On Tuesday morning, the patient got the COVID-19 shot and was fine. This morning (15Jan2021), the patient was not feeling great, has a slight headache, her breathing is heavier, and below her breast line is a tightness she can't really describe. The patient asked if these were a side effect of the COVID-19 vaccine and wondering if this is normal. As a treatment for the events, the patient took paracetamol (TYLENOL). The patient asked if she can or should get a test, a COVID-19 test. It has been so many days since having the vaccine, 4 days later, she is wondering if she might have COVID-19. The patient isn't sure and is just asking a question. It is confirmed that she has not had a test or tested positive for COVID-19. The outcome of "Not feeling great" was unknown. The patient had not recovered from the remaining events.
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| 73 | 2021-01-31 | panic attack |
Patient first mentioned that her tongue "felt funny." She described it as NOT tingling, she just be...
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Patient first mentioned that her tongue "felt funny." She described it as NOT tingling, she just became aware of its presence in her mouth & it felt funny. This progressed to a a slight swelling of the tongue, and then some emotional panic. Within 30 seconds she was calmed & her initial panic was diminished. Upon examination, & true to her new description, only the very center of her tongue was swelled. She was able to breath & swallow with ease. She took 2 Benadryl 25mg capsules & remained at the pharmacy for an additional 30 minutes. Her tongue had returned to normal & was counselled on what to do if any sign of the the problem rebegan. No further issues have occurred.
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| 73 | 2021-02-01 | feeling abnormal, fear, loss of personal independence in daily activities |
she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chi...
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she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chills; nausea; She had a terrible headache; Feeling freezing cold; she was going to faint; She thought she was losing her mind; slight pain in her arm/sore arm/sore spot; She feels weak, and is still weak; She couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The patient had the first dose of the vaccine on 10Jan2021 and didn't have a reaction, but had a slight pain in her arm on 10Jan2021. Her sore arm started on 11Jan2021. There was a sore spot and when she would pick up her arm it was sore and achy. No pain, but sore and achy. It lasted for a day or two. She didn't have any symptoms until Saturday the 16Jan2021, this past Saturday she thought she was dying. She had chills, nausea, feeling freezing cold, and had a headache. She thought she was losing her mind. The headache just stopped today. She had the chills that would not stop and she thinks she broke the sweat on Sunday (17Jan2021). She had a little nausea and couldn't eat anything on 16Jan2021. She had a terrible headache, which just stopped about 2 hours ago. She stated she must have to take 10 Tylenol over the course of time, every 4 hours. On Saturday 16Jan2021 she was just laying on the floor in pain. She was not even eating, just drinking water. All of her symptoms stopped this morning around 5 AM (18Jan2021). She had a big sweat. She is unsure if she had a fever because she does not have a thermometer. She is unsure if she has recovered completely from these symptoms. She feels weak, and is still weak (on Jan2021). She cannot go out or get dressed or shower. She is not strong enough. She is just sitting up now, no longer laying in bed. She couldn't walk (on Jan2021) and was afraid she was going to faint on 16Jan2021. She can walk a little bit now and feels a little bit better. She has been out of it for three days, She hasn't felt good. She asked if side effects can appear 6 days later? Is this normal to have a reaction 1 week after getting it? She asked are the side effects worse after the second dose? She asked is this Covid or side effects, what are the COVID symptoms? She asked should she take the second one if she had these side effects? Caller clarifies this is the Pfizer COVID Vaccine. Whoever vaccinated her did not give her the paper about it afterwards. Her neighbor brought it to her cause they went together. She did not realize she could experience these things. She did not expect them a week after getting the vaccine. She thought she had COVID. She asks, "do you think I have COVID?" She is just now getting better and it has been 3 days of experiencing these symptoms. Should she get the second vaccine? She is trying to do the right thing. Event outcome of chills, nausea, feeling freezing cold, and headache was recovered on 18Jan2021, for was going to faint and couldn't walk was recovering, for weak was not recovered, while for others was unknown.
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| 73 | 2021-02-01 | hallucination |
Having hallucinations at night when sleeping, very scary things. My hands completed shedding, almost...
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Having hallucinations at night when sleeping, very scary things. My hands completed shedding, almost like a snake shedding, front and back down to wrist
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| 73 | 2021-02-02 | confusional state | Extreme fatigue, very dizzy, headache, confusion |
| 73 | 2021-02-03 | restlessness |
Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination clien...
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Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination client complained of Intermittent chest pain in Left Upper Chest. Pulse regular, strong rate of 68. Resp 20, regular. BP138/90. 911 called. Pt now complaint of jaw pain on left side and throat soreness. Client was pale with no sweating. Fidgeting in seat. At 10:48 am EMS arrived. Client immediately transported to Hospital.
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| 73 | 2021-02-04 | anxiety |
Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious how...
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Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious however the hand numbness improved after 20 mins of rest and relaxation. Initially pt was hypertensive however after resting BP improved
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| 73 | 2021-02-05 | confusional state |
Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered men...
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Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered mental status, and a near syncopal episode upon arrival at the ED. Patient also reported some throat tightness and nausea. Patient received the first does of the Pfizer COVID vaccine about one hour PTA. Patient began having hypertension noted to be in the 180-215 systolics and patient reports baseline of 120s systolic. Patient was brought directly from the vaccine clinic to the ED. Upon arrival at the ED, patient experienced a syncopal episode and eventually came out of this but was confused. It was reported in the notes that patient was slightly dehydrated which could have contributed to her symptoms. Once the patient recovered from this episode and hypertension was resolved, patient was discharged home to follow up with PCP.
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| 73 | 2021-02-07 | feeling abnormal |
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weir...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weird", reported nausea and shortness of breath, and were found to have a blood pressue of 200/96 mmHg despite taking blood pressure medications that day. Patient was transported to the emergency department during which they had a brief episode of unresponsiveness and were non-interactive. On initial exam in the emergency department patient symptoms were improving: speech, sensation, and cranial nerves are intact, normal strength in all extemities, lungs are clear, and there is movement in all extremities. No rash, wheezing, or respiratory distress noted. Repeat vitals within normal ranges except blood pressure 151/87. Patient administered medication for nausea. Symptoms resolved and patient discharged to home stable.
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| 73 | 2021-02-09 | feeling abnormal |
feeling very dizzy; Very sick feeling; low grade fever; Vertigo; My head does not feel like it's att...
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feeling very dizzy; Very sick feeling; low grade fever; Vertigo; My head does not feel like it's attached to my body; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 12:30 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 73 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included heart stent. The patient has no known allergies. Concomitant medications included lisinopril, clopidogrel besylate (CLOPIDOGREL), metoprolol, rosuvastatin. On 21Jan2021 16:00 the patient started feeling very dizzy, vertigo, she stated: 'It's two days now I still feel it, very sick feeling, had a low grade fever, my head does not feel like it's attached to my body'. No treatment was given for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Information about Batch/Lot number has been requested.
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| 73 | 2021-02-09 | sleep disorder |
Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as w...
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Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as when had first dose. 4:30 pm -acetaminophen 500mg 10:30pm severe right arm and shoulder pain 8/10. Nausea 11:30 acetaminophen 500 mg. Was trying to not take any medication for fear it would effect negatively the vaccine efficacy. continued nausea Did not sleep first night kept waking groaning in pain/R arm shoulder 5:00 am acetaminophen 500 mg body aches and continued severe arm pain. 10:40 am acetaminophen 500 mg " and " and nausea 11:30 am severe body aches, chills and fever 99* with 500mg Acetaminophen. my Normal temp (96.8) 3:30 pm "
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| 73 | 2021-02-10 | depressed mood, insomnia |
a sharp pain was coming from the side of my back and shooting to my left breast/ a muscle on the sid...
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a sharp pain was coming from the side of my back and shooting to my left breast/ a muscle on the side going down of my back/ sharp pain when I make a turn or reach that goes to my breast; when she moves that she has a pain that goes through the lymph nodes or muscles behind her left breast; when she moves that she has a pain that goes through the lymph nodes or muscles behind her left breast; pain was either from something in her left shoulder, or the left side of her back, or a muscle; feeling a little down and out; she can't sleep in the heat at night; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982 ), via an unspecified route of administration at left upper arm on 23Jan2021 16:00 at single dose for COVID-19 immunization. There were on patient medical history and concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks).The patient said she did good on Saturday, 23Jan2021, saying her left arm didn't get sore. She said she did good on Sunday, 24Jan2021. She stated "I didn't get sore, but it just seemed like maybe a few days ago it seemed like a sharp pain was coming from the side of my back and shooting to my left breast (on 25Jan2021). It only does it when I am lying down and not when I am sitting down. I drank plenty of water and continue to drink plenty of water. Today, I am feeling a little down and out because of my breast (25Jan2021). My breast itself is not sore at all. It seems like maybe a muscle on the side going down of my back. There is a sharp pain when I make a turn or reach that goes to my breast. Well, if you have arthritis it could be that." She said it seemed when she moves or turns, she has a sharp pain in her left breast. The patient asked if the sharp pain she was experiencing in her left breast area were possibly her lymph nodes. She clarified her left breast was not sore, but the area behind her left breast has a pain go through it. She said it was just when she moves that she has a pain that goes through the lymph nodes or muscles behind her left breast. She said she normally doesn't sleep on her left side, but if she sleeps on her left side, the pain behind her left breast was better. She said she does not have big breasts and was not wearing a bra when she had the pain in her left breast area. She said she was wondering if the pain she has is from her lymph nodes or muscles in her back. She said the pain was either from something in her left shoulder, or the left side of her back, or a muscle. As treatment, patient reported that she has been holding her left breast area when she moves. She said holding the left breast area helps lessen the pain, but the pain was still there. She said she has been trying to troubleshoot her pain. She said she drinks coffee every day and thought maybe she was drinking too much caffeine. She said she can't sleep in the heat at night, so she turns the heat off in her house at midnight, but her house was still warm (70 degrees) when she wakes up in the morning. She said she thought that maybe the cold weather got into her back and left shoulder. She said she checked her left breast for lumps and didn't find any lumps. She said the only thing left for her to do was to contact her gynecologist and go have a mammogram. She doesn't take any medicine. She said she does take something for sleep as needed, but she would have to be going without sleep for a long time before she would take that medicine. She reported she is otherwise a healthy person. She said people talk about hormones changes after when a person used to have a period, and she sometimes doesn't know if her pain would be because of that. She said she may have irritation in her breasts from wearing a bra that may be too tight, but the pain she was experiencing now was different from that pain. The events did not require a visit to Emergency Room or Physician Office. The outcome of the events she can't sleep in the heat at night and feeling a little down and out was unknown; and not recovered outcome for the other events.
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| 73 | 2021-02-14 | feeling abnormal | Chills, muscular aches, headache, slight temperature general feeling miserable |
| 73 | 2021-02-15 | sleep disorder |
Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hou...
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Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous. Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read) Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
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| 73 | 2021-02-16 | hallucination |
psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible ...
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psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, "what is this Parkinson's?". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her "brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep." On Monday she experienced, "horrible palsy, as if her muscle was being pulled like a rubber band." Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.
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| 73 | 2021-02-16 | insomnia |
Approximately 36 hours after injection I became dizzy, could not sleep due to constant dizziness, o...
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Approximately 36 hours after injection I became dizzy, could not sleep due to constant dizziness, off-balance and found it difficult to rise from a sitting/laying position without being overcome by dizzy spells. Also felt slight tightness in my head. I begin to take my blood pressure which was well over what was normal for me. BP ranged from highest of 155/84 to 145/78. Blood pressure begin to lower as I begin to take my Blood Pressure medication doubling the dose from 5mg to 10mg Amlodipine. I also take the medication at night, versus my normal routine to take medication during the day. Not sure if this was just a coincident or precipitated by the vaccine.
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| 73 | 2021-02-19 | feeling abnormal |
more than 24 hours after 2nd injection, I began to feel achy and very cold. I had a fever of 100. ...
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more than 24 hours after 2nd injection, I began to feel achy and very cold. I had a fever of 100. I took two Tylenol at 8PM and again at 11PM. Today, I feel hazy and a little achy.
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| 73 | 2021-02-21 | feeling abnormal, mental impairment | Fatigue and brain fog, or dullness from Tuesday 02/09/2021 through Friday 02/12/2021. |
| 73 | 2021-02-21 | excessive sleepiness |
Pfizer-BioNTech COVID 19Vaccine EUA Fever of 99 degrees, slept for 32+ hours followed by aches for 1...
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Pfizer-BioNTech COVID 19Vaccine EUA Fever of 99 degrees, slept for 32+ hours followed by aches for 12 hours. General malaise,
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| 73 | 2021-02-22 | anxiety, panic attack, feeling abnormal |
A 73 yr old female was found sitting in the observation area after receiving her first Covid 19 vacc...
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A 73 yr old female was found sitting in the observation area after receiving her first Covid 19 vaccine (Pfizer). Pt began to have a ?fuzzy? feeling and feeling of dissociation from her body. The pt got the attention of EMS and a wheel chair was brought over to her to bring her the private exam room. Pt remained in wheel chair and vs were taken. Initial bp was 168/102, hr was 97, spo2 was 97% ra. Pt states she has anxiety and feels she may have had a panic attack. Pt rested for 10 mins and had a drink of water. Pt vs were Retaken and improved. Pt pub was 153/104, hr was 85, resp 18, spo2 was 97% ra. Pt signed a form that she accepted treatment but refused transport. Pt was released back to observation area and proceeded to check out.
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| 73 | 2021-02-24 | anxiety, irritability |
Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 ...
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Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective is a 73 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm/hand numbness . She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: none per pt. Not on any medication. She has not been back to her pcp for "several years". No known hx of htn. She does have a bp cuff at home. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1118 02/25/21 1136 BP: (!) 172/84 124/82 Pulse: 96 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Motor: Motor function is intact. No weakness. Coordination: Coordination is intact. Coordination normal. Gait: Gait normal. Comments: +5/5 strength to upper and lower extremities. Equal facial movement. Psychiatric: Mood and Affect: Mood is anxious (slightly). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved after monitoring. Pt monitored for 20 minutes. She feels well. More like anxiety than local reaction. Pt aware of what to watch for. Education on monitoring bp at home and recommended that she follow up with pcp sometime next week to get up to date on her physical and follow up on bp records she will have done at home. Electronically Signed 2/25/2021 11:33 AM
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| 73 | 2021-02-24 | mental status changes |
Emergency room HPI a 73 y.o. female who presents with NURSING HOME REPORTED TO EMS THAT PT WAS SHORT...
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Emergency room HPI a 73 y.o. female who presents with NURSING HOME REPORTED TO EMS THAT PT WAS SHORT OF BREATH FOR 1 WEEK AND GETTING WORSE. NURSING HOME REPORTED TO NURSE HERE THAT PT HAD ALTERED MENTAL STATUS IN THAT SHE WAS NO LONGER SCREAMING. PT IS UNABLE TO GIVE ANY HISTORY SECONDARY TO DEMENTIA
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| 73 | 2021-02-24 | restlessness |
Started with chills for about 1 hour then fever (about 100.4) and tired. It was now in the middle ...
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Started with chills for about 1 hour then fever (about 100.4) and tired. It was now in the middle of night when chills ended then I was very restless. It lasted about 24 hours then I felt fine - no fever.
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| 73 | 2021-02-25 | feeling abnormal |
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This ...
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Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
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| 73 | 2021-02-25 | feeling abnormal |
After about 10 minutes after receiving vaccine patient complained of shortness of breath, tingling d...
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After about 10 minutes after receiving vaccine patient complained of shortness of breath, tingling down to her fingers and feeling strange. I gave her 1 dose of EpiPen at site of injection. She did start feeling a little better. Paramedics came and she was transported to the hospital. I did speak with her later and she was feeling better. She did tell me that they didn't think it was an anaphylaxis reaction but a reaction to the vaccine
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| 73 | 2021-02-25 | loss of personal independence in daily activities, feeling abnormal |
ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching i...
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ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching in her shoulder, into her back; aching in her shoulder, into her back; weak and unable to function; weak and unable to function; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 16Jan2021 1:45 PM at a single dose on the left shoulder, right at the very top for COVID-19 immunization. Medical history included ongoing lupus since 1999. Concomitant medications reported were none. The patient experienced aching in her shoulder, into her back, dizziness, she was not quite herself on 16Jan2021; she ran a fever of 101 degrees, had lots of chills and sweating on 18Jan2021; she became weak and unable to function, and tired on an unspecified date in Jan2021. The patient stated she got the first dosage of the COVID-19 vaccine and had some side effects. She received the first COVID-19 vaccine on 16Jan2021. She had some aching in her shoulder and stuff on 16Jan2021. For 2 days, she was weak and unable to function. She ran a fever of 101 degrees on 18Jan2021 and was sweating head to toe. At the time of report, she currently had no fever, but was feeling very fatigued. She stated she is trying to make her next appointment, but she can't pull up the paperwork. She wants to know what to do about the side effects. Her next appointment on 13Feb2021. Her shoulder hurt an hour after she received the vaccine on 16Jan2021. That night and the next day, the whole shoulder even into her back started hurting. Like when she rolled over and laid down, she would say "ohhh, I can't lay that way". This lasted for a couple of days. Her shoulder is still tender, but it is much better. She can lift it up, move it around and it's not causing her any difficulty. She stated she became weak. The first night after receiving the vaccine in the middle of the night, she kind of had like a dizziness, she was not quite herself. She thought it was just part of the vaccine. The next day, she couldn't do anything. She was down for 2 days after that. On the 17Jan2021 and 18Jan2021, she was feeling really happy. On 18Jan2021, she started to have a fever. She had a fever that night and part of the next day. She had lots of chills. The fever and chills have seemed to go away. She just feels really fatigued after. She woke up twice and her whole body was soaked. She states that is all gone now. She has had no fever. She had a very good night last night. She stated her aches and pains were at a minimal. She stated she is 73 years old, so she is going to have aches and pains as it is. At the time of the report, all she has is fatigue. She added that the fatigue isn't coming from her, it's from the vaccine. She was very active usually. But at the time of the call, she would get up to do a little and then she would have to sit back down. She was very tired. She was feeling weak and out of pocket. She was so tired. She didn't want to do anything. She stated she must find someone who can print her new paperwork. She plans to call her doctor and see what he thinks about her receiving the second shot. She feels she really needs to get the second shot. During the report, she made the comment "I'm sorry, I'm choking on my cough". The patient underwent COVID-19 test on 14Jan2021 with result of negative. She also underwent blood test on an unspecified date with unknown results. The reported adverse events did not require a visit to the physician office or emergency room. Outcome of the event fatigue was not recovered, while outcome of the other events was recovered on an unspecified date in Jan2021. Information on the Lot/Batch number has been requested.
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| 73 | 2021-02-28 | anxiety |
Female patient experiencing chills 30 minutes after Pfizer vaccine administered. No other symptoms r...
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Female patient experiencing chills 30 minutes after Pfizer vaccine administered. No other symptoms reported. Vitals 140/90, HR 70, SPO2 100% on room air, Respirations 22, Temp 97.3 axillary. Patient appears anxious but states she is not. Emergency response activated/ 911 called. Benadryl administered via IM on right deltoid. Paramedics arrive at 1054hrs. Takes patient via gurney to further assess in ambulance. Patient is vitally stable. Refused further care. Left AMA.
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| 73 | 2021-02-28 | feeling abnormal | Mental state delayed, arm felt heavy, dry mouth, odd sensation in head-transfer to ER |
| 73 | 2021-02-28 | insomnia |
I developed a rash (in the evening and continued all night). The instructions I received was to see...
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I developed a rash (in the evening and continued all night). The instructions I received was to seek medical attention. I went to Urgent Care at 8 AM on Feb.25. I was instructed to take one tablet Claritin and then 2 Benedryls in the evening. By 5:30 PM on Feb 25 I was extremely uncomfertible and took two benedryls. Still could not sleep and at 11:30 PM took 2 more benedryls. When I woke up at 7:30 AM on Feb 26, the rash was gone and has been gone since. I was also instructed not to take the second shot. (Which I will not)
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| 73 | 2021-02-28 | sleep disorder |
Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep becaus...
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Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep because I was just uncomfortable all over. Felt a little light headed. At 7:00 took temp,99.2,- my normal is around 97.7. Right arm was feverish and extremely sore,more so than first vaccine. All that day fever went up to 101.2 by the afternoon. Drank liquids all day. had a headache most of the day with all over joint pain. Never had the flu but think this must be how you feel. Fever broke around 3:00AM on 2/26. Upper arm remains sore, swollen,red and feverish as of today,3/1
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| 73 | 2021-03-02 | confusional state |
When I cough it was blood in that cough couple of times; Left leg swell up from my feet to all the w...
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When I cough it was blood in that cough couple of times; Left leg swell up from my feet to all the way up; When I woke up, I didn't know what time, what date, nothing; I was all confused; Feeling achy/ body ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL347, via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization at a health department because she was at high risk and she was 73. Medical history was not reported. Concomitant medications included unspecified medications. The patient had an injection done 2 weeks, not this last Friday, the Friday before that. They had to make her wait for half an hour before she left and she was okay. Then Saturday (23Jan2021), she started feeling achy but to she was okay. Then Sunday (24Jan2021), she had a very bad experience, she went and start watching TV and she fell asleep. When she woke up, she didn't know what time, what date, nothing. And she looked at the time on her TV and it said 6:45, she didn't know if it was am or pm. And it was dark outside and she didn't know if it was Monday or Sunday. She was all confused, she called someone to make sure what day and time and all and still she was still confused. And then she had to call her aunt and then she told her no it's Sunday and it's night time and so on. Then she got better. Then during the week she didn't have that much body ache, she expected that because that was in that papers. Then today is Sunday, Friday morning (29Jan2021) she got up and she coughed, when she coughed it was blood in that cough couple of times. Then her daughter came over and took her to the hospital (hospitalization details were not clarified). She had lab work the day they took her in the emergency room. At the hospital, they did all kind of tests, on top of that her leg, her left leg swelled up from her feet to all the way up, all the way up. They thought that it could have been some blood clot. And they took test and all and nothing, everything was okay. They couldn't find out why her whole leg was swollen. On top of that, they did chest x-ray and they did something else she can't remember, another test. And they took all kind of blood work and all. And they did to see if she had the virus, the COVID. And yesterday they called her from the hospital and they said that she didn't have the virus. And she asked them about the blood work and they told her if there was anything more than they would call her. So, she thinks all this came from that injection. She called because this was not guaranteed if this was from injection. When confirmed that COVID test was negative and blood work report was not out, she stated they haven't called her that meant her blood work was okay. The swollen leg has been gone down and blood once in a while she sees a little bit. They gave her 2 prescriptions, one was antibiotic and one is steroid. Due date for the next shot is 12Feb2021. The outcome of the events was recovering.
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| 73 | 2021-03-02 | nervousness |
rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week fe...
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rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week feeling
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| 73 | 2021-03-03 | feeling abnormal |
Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and...
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Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and swelling around site of injection- still demonstrating on third day March 4
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| 73 | 2021-03-03 | sleep disorder |
Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed...
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Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed aches, chills and low grade temperature. Became lightheaded. Could not sleep due to symptoms. No appetite but drank herbal tea and water with added electrolytes. That severity of symptoms lasted until 3/4 at 6 AM. Still am having some residual effects as one might have with the flu ? fatigue etc. Temperature is gone no more chills appetite still diminished.
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| 73 | 2021-03-06 | feeling abnormal |
Day 6 after 2nd dose had debilitating headache lasting 3 days, muscle shaking, dizziness and some fo...
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Day 6 after 2nd dose had debilitating headache lasting 3 days, muscle shaking, dizziness and some foggy thinking. this is day 10 headache duller now but other symptoms present
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| 73 | 2021-03-07 | excessive sleepiness, confusional state, sleep disorder |
Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next m...
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Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next morning after Covid shot, my blood sugar was 350. It continued that way for days. I started using more insulin the night before (when I usually take it). So I HAD been taking only 45 units at night. I was cautious and increased to 65 units on the 3rd night. That reduced my morning blood sugar readings to 220. Per my doctor's instructions, I have been taking that amount every night, but my blood sugar has only gone down to 175. This was my MAIN concern. But here are the other physical effects that have occurred since 2-25: great thirst, Joints hurt, teeth hurt, confusion, headache, fatigue, sleeping almost all day - all of these days since the shot. Something new started just last night (3-7-2021). Both of my legs hurt so much I could not fall asleep. They still hurt this morning. My joints ache in my hips, knees - Much worse than they normally do.
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| 73 | 2021-03-07 | sleep disorder |
3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5:...
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3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5: Morning; headache, fatigue Evening/overnight: arm still tender 3/6: Morning: fatigue, nausea, headache, lack of appetite, stomach upset. Hot flashes, no fever detected Afternoon: very nauseous, vomiting, headache Evening/overnight: not getting restful sleep 3/7: Morning: mild headache/lack of appetite Evening/overnight: woke in the middle of the night with severe stomach cramps, loose stool, nausea amd vomiting. No fever detected. 3/8 continues to be nauseous, lack of appetite and extreme fatigue.
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| 73 | 2021-03-08 | sleep disorder |
Awakened at 2:00 am with low grade fever and muscle and bone aches. (ankle, knees, hip joints, back)...
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Awakened at 2:00 am with low grade fever and muscle and bone aches. (ankle, knees, hip joints, back) Experienced low grade fever and chills occasionally for3 days following injection. Today is day 4 and I have no side effects.
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| 73 | 2021-03-09 | sleep disorder |
Covid Pfizer #2 was injected high into my right shoulder (bursa) area instead of the deltoid muscle ...
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Covid Pfizer #2 was injected high into my right shoulder (bursa) area instead of the deltoid muscle area. Unlike shot #1 on 02/16/21, where I could not even feel the needle in my left arm, this injection into my shoulder was immediately painful. As the day progressed, my upper arm had to be massaged to reduce the pain, my wrist and fingers tingled, and I could not use my right arm for normal activities. Overnight, I had difficulty finding a comfortable position for sleeping. I fear a bursitis condition will develop requiring further treatment.
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| 73 | 2021-03-12 | amnesia | Amnesia began 30 hours following injection and lasted for 6 hours |
| 73 | 2021-03-13 | confusional state |
Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptom...
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Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptoms included confusion, lethargy, aches, headache and fever.
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| 73 | 2021-03-14 | loss of personal independence in daily activities |
chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and tol...
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chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and told it will go away in a couple of day. Stayed in bed all day on the 12th of March and woke up about 8:00 on the 13th and only symptom which I still have today is sore arm at point of vaccination. other meds Lorazepam .05mg,Aspirin 81 mg, Acyclovir 400 mg, Vita D, Vita B12,Align, Estroven. Turmeric, One a day vitamins,Coq10
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| 73 | 2021-03-14 | mental impairment, nightmare |
None with Shot 1 Shot 2 : Headache, fatigue, nausea, vomiting, diarrhea, nightmares, unclear thinki...
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None with Shot 1 Shot 2 : Headache, fatigue, nausea, vomiting, diarrhea, nightmares, unclear thinking, instability on feet 2days recovery except for headache and fatigue remain Imodium Zofran Sumatriptan Fully recovered except for headache and fatigue
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| 73 | 2021-03-16 | disturbance in attention |
Light headed Hard to focus Heart pounding and racing to the point I thought I was going to pass out....
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Light headed Hard to focus Heart pounding and racing to the point I thought I was going to pass out. It lasted two hours I did not feel normal for 4 days
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| 73 | 2021-03-16 | feeling abnormal |
11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavende...
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11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavender splotches when eyes open; no strength in arms or legs: collapsed trying to get out of bedroom to bathroom & couldn't get up unassisted; collapsed again trying to get from bathroom back to bed - couldn't scoot or pull/raise myself up with my arms; needed help to sit & rest& collect myself; arms/legs had no strength at all.... couldn't move unassisted; took unknown amount of time for husband to help me back to bed....once in bed slept until 6AM.. still weak the following day but vision back to normal - used walker to get around..head still buzzing
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| 73 | 2021-03-17 | depressed mood |
Within the first 15 min. a sharp pain was felt in my upper arm about six inches below the injection ...
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Within the first 15 min. a sharp pain was felt in my upper arm about six inches below the injection sight. The pain subsided and I thought no more about it. My arm was sore for about 5 days. I was extremely tired the first day or so and took a day time nap the next day which is unusual for me. I felt lethargic for two weeks and went into what I call a funk - a very minor depression. Exactly two weeks later the funk lifted and I felt normal. I received my second shot on 2/19/21. About that time (can't remember if it was before or after the second shot) I felt a sharp pain in my left arm in the same spot where the initial pain was. I massaged my arm and took Tylenol and that was the end of it. I've had a couple of other episodes since with less discomfort each time. I have simply massaged my arm and it's gone away. After the second shot I slept for about 2 to 3 hours in the afternoon the next day. I felt somewhat lethargic for a few days and a minor funk for a few days, but nothing more. The pain in my arm is the unusual symptom. I broke that arm just below the elbow two years ago. I don't know if that might have anything to do with the situation or not.
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| 73 | 2021-03-17 | disorientation, confusional state | Disorientation, confusion, dizziness |
| 73 | 2021-03-18 | memory impairment |
Patients physician calls about confusion with cognition and memory issues. She is also still having ...
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Patients physician calls about confusion with cognition and memory issues. She is also still having balance issues with extreme fatigue.
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| 73 | 2021-03-19 | nervousness | INCREASED HEAR RATE NERVOUSNESS TROUBLE BREATHING |
| 73 | 2021-03-19 | restlessness |
5 min post shot had tingling around lips lasted 3-5 minutes . 8 hrs after shot - at rest - heart fl...
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5 min post shot had tingling around lips lasted 3-5 minutes . 8 hrs after shot - at rest - heart fluttering - Bounding pulses - restlessness - felt 1-2 irregular beats per minute - heart rate My Normal at 90-100. Lasted 3 hours Still continues periodically thru the day / Even at rest - restlessness continues/ BP elevated at doctors office yesterday 3/18/2021. EKG in office report says abnormal. SVT and Other changes. Haltor monitor and echocardiogram ordered And first available scheduled for 3./25/2021. Scheduled cardiologist for 4/12.2021.
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| 73 | 2021-03-20 | disorientation |
disorientation, difficulty talking, difficulty walking, exhaustion. This has happened before, for in...
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disorientation, difficulty talking, difficulty walking, exhaustion. This has happened before, for instance as a result of flu. She recovers in a few days. This is NOT a stroke or heart related event.
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| 73 | 2021-03-20 | feeling abnormal, mental impairment | felt "funny" hard to think, heavy arms, EMS transported to ER |
| 73 | 2021-03-20 | feeling abnormal |
Woke up around 10 am, turned to my head to the left in bed, and had extreme virtigo, nausea and one ...
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Woke up around 10 am, turned to my head to the left in bed, and had extreme virtigo, nausea and one bout of vomiting. After a two hour nap felt better although still fatigued and a little off. Next day still fatigued and off but virtigo disappeared.
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| 73 | 2021-03-22 | disorientation, hallucination |
AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & leth...
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AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & lethargic. My friend came over took my blood pressure it was 144/75 I was freezing and the room was 80degrees I had absolutely no appetite. My head felt like it was going blow up Next day was Tuesday 3/16/2021 I woke still groggy & bad headache but now I was hallucinating & i was burning up & sweating profusely Next day 3/17/21 still out of sync & very disoriented Thursday 3/18/21 had video dr appt at 1:00pm he told me to ride it out gave me something to sleep & some tramadol for pain Friday 3/19/21 started coming out of it I felt like i was dying if thats what it feels like
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| 73 | 2021-03-24 | confusional state |
I felt paralyzed, unable to move or speak after a nap. It lasted several hrs. and I thought I migh...
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I felt paralyzed, unable to move or speak after a nap. It lasted several hrs. and I thought I might be dehydrated. A friend had to assist me to sit up and drink water. I had confusion and difficulty speaking in complete sentences. No treatment sought. Pt reported this on 3/25/2021 as her response to her first dose, after already having then had her 2nd dose.
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| 73 | 2021-03-24 | feeling abnormal, disturbance in attention |
Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling be...
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Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling better by noon. ongoing waves of brain fog, pressure behind my eyes. I seek no treatment, hope it will improve with time. Would like to know if it is advisable to have the second dose. I do not want to repeat the previous experience. Are you able to advise? Thank you
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| 73 | 2021-03-24 | sleep disorder |
Pain in shoulder at injection site, especially when exercising, when lying down, and upon exertion. ...
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Pain in shoulder at injection site, especially when exercising, when lying down, and upon exertion. Pain in arm is staying the same and not getting better. Wakes me up and keeps me up occasionally.
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| 73 | 2021-03-24 | thinking abnormal |
Shortness of breath, severe muscle aches, eyesight impacted, impacted thought processes. This shot ...
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Shortness of breath, severe muscle aches, eyesight impacted, impacted thought processes. This shot is NOT SAFE!!!!
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| 73 | 2021-03-25 | anxiety |
Shortness of breath, tiredness, anxiety. BPs 145/65 (pulse 68), 121/63 (pulse 66). O2 sats 94% to 95...
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Shortness of breath, tiredness, anxiety. BPs 145/65 (pulse 68), 121/63 (pulse 66). O2 sats 94% to 95%. Had a rough morning and was a bit anxious. Let the patient vent about her day - SOB resolved.
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| 73 | 2021-03-25 | feeling abnormal |
With both COVID vaccines pt experienced raspy voice, hoarseness, funny feeling in bronchial tubes. ...
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With both COVID vaccines pt experienced raspy voice, hoarseness, funny feeling in bronchial tubes. Pt denies SOB, CP or anaphylaxis. Her symptoms started approximately 1 hour after admin and resolved within 3 hours of onset.
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| 73 | 2021-03-25 | excessive sleepiness |
Got the vaccine and within 30-an hour she was seated, waiting and she developed a tingling/numbness ...
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Got the vaccine and within 30-an hour she was seated, waiting and she developed a tingling/numbness on her bottom lip to the center of her lip. It spread throughout the entire bottom lip. Then it moved to the left hand corner of her mouth as well, and then moved up to the left side of her face to her eye, and then to the corner of the left hand of her head. This is a tingly pressure, and it then developed into a hard headache concentrated in one spot. She went into heavy sweating. The pharmacist was watching her and came over to her, she was there for about an hour and a half. She had a bottle of water trying to cool off, and her tongue was getting a bad taste in her mouth, and numbness in the back of her tongue. The pharmacist gave her Benadryl to take and she sat there for a while and was starting to feel really shaky, and she thought she would go back to her apartment to get out of being around other people. She was feeling weak to walk, and overwhelmingly tired. Once she did get into her apartment she her taste buds felt dry. After several days of this reaction, little by little it subsided, but the sweating and chills continue even up until today, 3/26/21. She goes to bed dry and wakes up soaked from sweat due to profuse sweating. She has been yawing a lot lately and if she does yawn she immediately has chills. It's been back and forth with the chills/fever. She can be perspiring on one end and the other end cold. She tried to talk to her doctor but told her to seek out UC for her symptoms as he is too busy. There is eye strain that is bothering her which leads her into wanting to sleep and sleeps for extended periods of time and really exhausted. Has also had runny nose, hands and feet swelling. Her right hand is kind of like a tingling/weakness sensation.
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| 73 | 2021-03-26 | hallucination, disorientation, confusional state |
2 weeks post-vaccine significant onset of confusion, disorientation, hallucinations, cognitive decli...
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2 weeks post-vaccine significant onset of confusion, disorientation, hallucinations, cognitive decline. Hospitalized?> ?encephalopathy ? of unknown origin
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| 73 | 2021-03-26 | sleep disorder |
After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 day...
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After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 days went to urgent care checked out OK but symptoms persist to this day. On 3/13 severe dizziness and vomiting and blacking out and went to ER. Admitted overnight. Pulmonologist prescribed course of Prednisone on 3/15 and ending on 3/25. Some relief for chest tightness Neuropathy has gotten steadily worse with inclusion of face and lower leg. On 4th day began some ringing in ears which is to this day louder. Have fatiugue, sleep issues, trouble focusing my brain and eyes. Everything is worse today. Can't hold my head up. Will someone please help me
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| 73 | 2021-03-29 | feeling abnormal |
Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurt...
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Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurts; This is a spontaneous report from a contactable consumer via medical information team.A 73-years-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number :unknown) via an unspecified route of in Arm Right on 04Feb2021 07.00 as single dose for covid-19 immunisation. Medical history included asthma from 1971 , oesophageal spasm from 1981, diverticulitis ,concussion syndrome, anaphylactic shock .She has had anaphylactic shocks 4 times in her life. Concomitant medication included fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma, fluticasone propionate/salmeterol (WIXELA INHUB) taken for asthma. On 04Feb2021 the patient stated couldn't get out of bed. On 09Feb2021 the patient experienced oxygen level decreased, heart rate increased. In Feb2021 patient experienced tired , dizziness and joints hurts.It was reported that She didn't have any anaphylactic shock after the COVID-19 vaccine. She had no reaction. After receiving the vaccine, she sat there with her husband for half an hour. In fact, nothing was wrong with her for 2 hours after receiving the vaccine. Then all of a sudden later on that day, she couldn't get out of bed. It was like she was sleeping, but wasn't sleeping. This lasted from Thursday around 11 a.m. until Monday, that kind of thing. She went to the doctor that Tuesday because she had her physical already scheduled .When she went to the doctor, it was determined her heartrate was 120. Her heartrate sitting or resting is usually in the 80's. Then, her heartrate was 120's four days after the vaccine. She didn't realize a racing heartrate was one of the severe effects of the vaccine. She didn't feel her heart was racing. Her doctor instructed her to drink Gatorade and Pedialyte and she is still tired after doing all of that. Her doctor said she should have the shot, even though her blood heartrate went up 40. Her oxygen level is usually at 98 although she does have asthma, and her level was at 90. It was lower, under 98. She explains she had an EKG done at the doctors.She stated she was extremely dizzy in the beginning when she did get up and take a shower. Every day, her husband helped her get in the shower and take a shower. She received her first EKG when she went to the doctor on Tuesday 09Feb2021. The only thing wrong was her heart rate was 120. Her heart rate is usually high anyway usually 80 and sometimes 90. Thee has only been one time in the last 25 years, her heart rate went to 126. On 15Feb2021 EKG which showed HR as 106, oxygen was 96. The patient did not received prior vaccinations within 4 weeks. The outcome of the events dizziness was recovering, outcome of the event joints hurts was not recovered and outcome of the events were unknown
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| 73 | 2021-03-29 | feeling abnormal |
Mar 25 Day 1 -- 9:30 am vaccine shot. 10:00 am, nose cold, hands cold, chills slightly. 11:00 am hea...
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Mar 25 Day 1 -- 9:30 am vaccine shot. 10:00 am, nose cold, hands cold, chills slightly. 11:00 am headache and The start of my head feeling strange continued throughout the rest of the day, headache, strange feeling in my head (like my head was full of fluids and I was off-balance, a dizzy sick like feeling) flu like symptoms continued. 6:00 pm I was getting irregular heartbeats. Shortly after I got tachycardia which lasted about 15 to 20 minutes. Continued with a higher than normal heart rate. 8:00 pm went to bed to calm my heart. Could not sleep all night. Mar 26 Day 2 Continued with headache, strange feeling in my head (like my head was full of fluids and I was off-balance, a dizzy sick like feeling) no room.
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| 73 | 2021-03-30 | feeling abnormal |
arm very sore; feeling just awful; could not move legs without help; This is a spontaneous report fr...
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arm very sore; feeling just awful; could not move legs without help; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female consumer (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), via an unspecified route of administration administered in arm left on 27Feb2021 at 10:15AM as single dose for covid-19 immunisation. Medical history included ongoing myasthenia gravis, No Pituitary, COVID prior vaccination and codeine allergy. The patient had other medications in two weeks. The patient was fine on the day of vaccination. Next day on 28Feb2021 06:00AM, the patient could not move legs without help and arm very sore. Generally feeling just awful. Second day mostly the same. Woke up third day and all symptoms gone. No treatment received for the events. The outcome of the event was recovered in Mar2021. There was no COVID tested post vaccination.
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| 73 | 2021-03-30 | excessive sleepiness, feeling abnormal, disturbance in attention |
couldn't concentrate at all or read the newspaper; extreme fatigue and exhaustion; slept 19 hours ou...
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couldn't concentrate at all or read the newspaper; extreme fatigue and exhaustion; slept 19 hours out of a 24 hour period; brain fog; This is a spontaneous report received from a contactable physician reporting for herself. A 73 years old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283) at single dose via an unknown route in right arm on 08Feb2021 14:00 for Covid-19 immunization. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) on 18Jan2021 12:30 PM in right arm for Covid-19 immunization. Medical history included chronic mild-medium renal failure s/p left nephrectomy and adrenalectomy in 2017 due to left renal cancer, followed by severe renal failure one month p/o. Breast cancer p/o left mastectomy and reconstruction in 2005, hysterectomy in 2007, and mild hypertension which was treated. Patient had no known allergies to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination included citalopram, bupropion, lisinopril, zolpidem, etc. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 11:00, patient experienced extreme fatigue and exhaustion. Patient slept 19 hours out of a 24 hour period and had significant brain fog, where she couldn't concentrate at all or read the newspaper. No treatment was received for the events. Outcome of the events was resolved.
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| 73 | 2021-03-30 | insomnia | Severe arm pain that is preventing sleep. Ongoing since onset - currently 2/3/21 through 3/31/21 |
| 73 | 2021-03-31 | excessive sleepiness |
two days: shaking chills, fever, fatigue (could not stay awake more than 2 hours in row, nap for 3 h...
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two days: shaking chills, fever, fatigue (could not stay awake more than 2 hours in row, nap for 3 hours before wake up) two more days fatigue (4th day went to library and food cart for less than two hours, so tired could not walk up stairs in home until rested for an hour reading) two more days low energy but functional. Issues with temperature (5th day went to chiropractor and temperature 95.6 instead of normal 96.8. Fine after a week (temperature still slightly low at 96.4 at 9 days out)
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| 73 | 2021-03-31 | sensation of foreign body |
nurse was called to the monitoring area to evaluate a patient at 1505. Patient was sitting in chair,...
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nurse was called to the monitoring area to evaluate a patient at 1505. Patient was sitting in chair, AAO x 3, complaining of itchy ears and a lump in her throat. Patient had dose #2 of the Pfizer covid vaccine (Lot # EN6207, exp. 7/31/21) today. Patient stated she had dose #1 of the covid vaccine and needed to take oral Benadryl when she got home for similar symptoms. Patient had no visible rashes, denied any chest pain or feeling short of breath. VS were assessed: BP 120/78, HR 79, pulse ox 98%. Patient drank some water and stated she did not feel any worsening of symptoms. Patient was offered IM Benadryl but refused. Patient took her own Benadryl orally. Pulse ox was rechecked (98% ) and HR was 74. No distress was observed. Patient was held for an additional 20 minutes for observation. Patient had no worsening of symptoms during this time. Patient left without further incident. She was advised to call Emergency responders should she have any worsening of symptoms including rash, hives, or shortness of breath. Patient verbalized understanding
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| 73 | 2021-04-01 | feeling abnormal, memory impairment, sleep disorder |
Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in ri...
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Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation. Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-04-01 | loss of personal independence in daily activities |
After the first vaccine, had problems with balance that resulted in a fall and hip fracture. After t...
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After the first vaccine, had problems with balance that resulted in a fall and hip fracture. After the second vaccine, had much fatigue on day 1 after the shot; on day 2 had bad headache and fatigue; day 3 was nauseous all day and vomited once so did not eat much; day 4 had Diarrhea nausea vomiting. Moving my head seems to be causing nausea and vomiting so trying to keep it still. Have not been able to do much since getting the shot. Writing this report on day 4 after the shot.
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| 73 | 2021-04-05 | irritability |
Patient reports strange pressure in the head and headache starting 3 days after vaccination - fairly...
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Patient reports strange pressure in the head and headache starting 3 days after vaccination - fairly constant and hasn't resolved yet. Also stated being irritable when she never was before, high pitches in music bother her, and reading is difficult for her. She had an eye exam and they told her the pressure wasn't related to the eye.
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| 73 | 2021-04-06 | feeling abnormal |
Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vo...
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Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vomiting; vision changes; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, glaucoma, Manages cholesterol, controlled high BP and iodine contrast. The patient's concomitant medications were not reported. The patient experienced neuropathy, shortness of breath, chest tightness , ringing in ears, fatigue, brain fog, dizziness, vomiting and vision changes on 10Mar2021 03:00. The patient was hospitalized for all of the events for 2 days on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Mar2021. The patient was not pregnant. Outcome of the events was not recovered.
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| 73 | 2021-04-06 | mental impairment, feeling abnormal |
After the second dose I barely had side effects. The following day I felt my arm was sore at the inj...
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After the second dose I barely had side effects. The following day I felt my arm was sore at the injection site and it lasted for about 2 days. I also noticed that my left knee that I was having physical therapy since after the 1st dose due to nerve pain in the knee and upper calf area had stopped working. It had improved a lot and after the 2nd dose the improvement stalled. I also felt mild fatigue for quite a while and noticed that I developed a sensitivity to wine. I always drink 2 glasses of wine at night and now, after the 2nd dose I can barely drink one and I feel comatose. I feel extremely sleepy fast and just can't function.
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| 73 | 2021-04-06 | sleep disorder |
No soreness or pain at the injection site. About 12 hours after the vaccine, I started feeling very ...
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No soreness or pain at the injection site. About 12 hours after the vaccine, I started feeling very cold and had a sort of disturbed night. The next day I did not want to do anything, it felt like I had the flu. I felt fatigued, like I had some pressure on me. My next night was more or less normal and the next day I felt more or less normal. I started probably before the second dose feeling my left knee swelling. I also felt like a nerve pain, in on the left knee. The right one did not bother me at all. It is not just a knee pain it is like a nerve pain the knee and the upper calf. My knee feels inflated like a bike tire. My left knee is now much less mobile than my right knee. I did not see my doctor, just called his office and said I was concerned about a DVT so he suggested the ultrasound and later one physical therapy. The PT helped me a lot in the beginning but then stopped getting any better and still does not feel right.
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| 73 | 2021-04-07 | loss of personal independence in daily activities |
Chills, fever, every inch of body aching, intestinal AGONY, rash, headache, nausea, incredible fatig...
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Chills, fever, every inch of body aching, intestinal AGONY, rash, headache, nausea, incredible fatigue, shot site pain - full blown flu/virus. Day 8 and still so fatigued cannot DO anything. Diarrhea has stopped, thank goodness, but headaches remain and arm still aches. I HAVEN'T BEEN THIS SICK IN YEARS.
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| 73 | 2021-04-08 | feeling abnormal |
Patient stated she felt a weird feeling in her chest. Patient admitted to ETOH and drug use. Transpo...
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Patient stated she felt a weird feeling in her chest. Patient admitted to ETOH and drug use. Transported to hospital
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| 73 | 2021-04-08 | excessive sleepiness |
By afternoon just feeling sluggish and tired. Did have chills and just slept alot. Didn't feel like ...
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By afternoon just feeling sluggish and tired. Did have chills and just slept alot. Didn't feel like eating. Drank water only, then decided to have chicken soup. Had one sip and started feeling faint. Went back to bed and then felt like vomiting and had diarrhea also. Just went to bed for the evening and only had that one instance. By morning felt much better, but still a little slow. So the vomiting and diarrhea was just like my 6th day experience with my first covid shot, now wondering if it was the vaccine too.
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| 73 | 2021-04-10 | impaired work ability | Loss of breath after working for a very short time. |
| 73 | 2021-04-11 | feeling abnormal |
Very achy body. Chills. extreme fatigue. Head aches . Couldn't stay awake felt too bad. tired ...
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Very achy body. Chills. extreme fatigue. Head aches . Couldn't stay awake felt too bad. tired all day and forced to Slept at least 3 hours in the afternoons. This went on for a good week.
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| 73 | 2021-04-11 | panic attack |
She got her vaccine and had a rapid rise in BP and pulse, and ended up in the UC. From there she wa...
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She got her vaccine and had a rapid rise in BP and pulse, and ended up in the UC. From there she was sick and down for 8 days with body aches, prickly feeling all over her skin, just general fatigue and feeling sick. At 7 days after the vaccine she started with some arrhythmia problems, and had acute anxiety. Muscles/ribs very sore to touch. Whole upper body is inflamed. Those symptoms continued for 7 weeks, but the inflammation decreased in the muscles/joints diminished. 7 weeks after receiving the vaccine because of the acute inflammation and anxiety she ended up 3 nights and days with no sleep. She went to the UC again and they gave her something for that. She is still having heart arrhythmias as her heart is inflamed. Then starting the 1st week in April she started getting sick. The arrhythmias increased to palpitations to PVC's that began to increase. She became dizzy, light headed at times, the nausea started, the palpitations were painful and then went to see a cardiologist. He is trying to get medications to stop the palpitations. So far they are waiting for the medication to take effect. She has been down for 5 days, she is weak, dizzy when she is up. Her BP and pulse are stable, EKG is normal. She is also having what she is calling surges and/or storms, acute anxiety storms that rush through her body which makes her body feel like fire rushing through her body, acute panic. It causes her to have to lie down and curl up, fatigue, dizziness and nausea to go with that. It does subside slowly, but takes about 2 hours. She has ongoing symptoms that are increasing in severity and are trying to treat the symptoms, but so far just waiting for things to work She has never been sick, never had anxiety issues. There is nothing in her environment that would cause these reactions. She believes that the storms are being brought on by the storm surges that are coming and going.
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| 73 | 2021-04-11 | sleep disorder |
Patient states she felt swimmy and lightheaded right after vaccine and she was given water to drink....
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Patient states she felt swimmy and lightheaded right after vaccine and she was given water to drink. She sat and was observed for 30 minutes. Upon arriving home she states she had extreme fatigue and took a nap which is very unlike her. Then that same day she started to have difficulty breathing after her nap (couldn't catch her breath). She contacted the pharmacy and later contacted her doctor who told her to wait 48 hours to see if difficulty breathing subsides. Doctor put patient on a Medrol dose pack on 3/25/21. Approximately 5 days after initially receiving vaccine patient developed redness and flushing in her face. The facial redness went away after 3 days. Patient says overall the difficulty breathing occurred for 9 days and it was bad when trying to sleep at night, she kept having to sit up and was gasping. Patient also had acupuncture and a laser treatment done by her physician to help with this adverse effect.
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| 73 | 2021-04-12 | confusional state, disorientation |
twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also ...
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twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived.
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| 73 | 2021-04-12 | feeling abnormal |
10 minutes after receiving vaccine, felt fuzzy, lightheaded, dizzy, and fatigued. Rested under super...
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10 minutes after receiving vaccine, felt fuzzy, lightheaded, dizzy, and fatigued. Rested under supervision, felt nauseous with no vomiting. No LOC, no SOB, no CP. Vitals monitored, requested ambulance transport, taken to ED
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| 73 | 2021-04-12 | feeling abnormal |
ischemic stroke; vision changes; When looking up her vision was blurry & unclear; fuzzy; This is a s...
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ischemic stroke; vision changes; When looking up her vision was blurry & unclear; fuzzy; This is a spontaneous report from a contactable consumer (Patient) reporting on herself. A 73-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Lot no: ER0734) on unspecified route of administration on right arm (at the age of 73-year-old) as SINGLE DOSE on 28Mar2021 (between 14:30-15:00) for covid-19 immunization. There were no prior vaccinations within 4 weeks reported. The patient's relevant medical history included ischemic stroke, breast cancer, lymphedema in left arm and tendonitis in her right arm. The patient's concomitant medications were not reported. On 29Mar2021, the patient experienced vision changes. Upon follow-up (30Mar2021); When looking up her vision was blurry & unclear and the symptoms lasted for around one-two hours. On 29Mar2021, the patient looked at the clock on top (about 10' away), all the numbers were fuzzy. The patient said the numbers on the clock were 1 in height & she couldn't read them & her vision was very fuzzy. The fuzzy vision lasted approximately between 1-1/2 to 2 hours. It was reported that the patient vision recovered completely 1-1/2 to 2 hours afterwards. On an unknown date, the patient had ischemic stroke. The outcome of the events ischemic stroke, vision changes and vision blurred was unknown Follow up was needed, further information has been requested.
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| 73 | 2021-04-12 | feeling abnormal |
When I lay down my head the room swims. I need to take several minutes when I get up otherwise it's ...
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When I lay down my head the room swims. I need to take several minutes when I get up otherwise it's like I feel someone is slamming me down on the bed. I have no headaches, or nausea. Once I stand I'm fine but I cannot lie down and do exercises, walk and then turn quickly or walk with my head down. I've fallen twice now. It's been over 2 weeks since I've had my last vaccine. My mind seems cloudy.
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| 73 | 2021-04-13 | excessive sleepiness, loss of personal independence in daily activities |
For 8 days after the shot had to sleep 16 hours a day, had nausea, headache, vomited twice, diarrhea...
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For 8 days after the shot had to sleep 16 hours a day, had nausea, headache, vomited twice, diarrhea once, no appetite. 2 was after the vaccine, I still am not feeling well. I get headaches easily and am not up to usual level of functioning.
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| 73 | 2021-04-16 | feeling abnormal |
I had no symptoms until 4 weeks after the shot. Then on April 8 after my routine exercise I was so ...
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I had no symptoms until 4 weeks after the shot. Then on April 8 after my routine exercise I was so tired I sat in a chair feeling unable to do anything for hours. A headache kept getting worse and worse. Aleve helped but then it came back in force. By that evening I started to throw up. This went on all day Friday -fatigue. the worst headache I've had in years, and throwing up. I was weak but feeling better by Sunday. My family and friends did not believe that a reaction could happen so late, but I am sure that this was a reaction to the shot. My thinking was fuzzy and I would get dizzy through yesterday 4/16. Hopefully everything is back to normal now.
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| 73 | 2021-04-17 | feeling abnormal |
Aching, pain, redness and warmth at shot site. Chills. Fever. Brain fog. Dry heaves. VERY tired. ...
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Aching, pain, redness and warmth at shot site. Chills. Fever. Brain fog. Dry heaves. VERY tired. Dizzy
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| 73 | 2021-04-17 | loss of personal independence in daily activities |
Could understand words but could not answer back; Her symptoms came out as if she was having a strok...
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Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
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| 73 | 2021-04-18 | feeling abnormal | Breathing, head ache, tired, brain fog, ached, neopthry in feet and hands, chills, dry heaves, fever |
| 73 | 2021-04-19 | loss of personal independence in daily activities |
A week after dose 1 developed weakness in her legs, now having worsening weakness and activity intol...
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A week after dose 1 developed weakness in her legs, now having worsening weakness and activity intolerance
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| 73 | 2021-04-20 | nervousness |
patient said "I feel high", appears shaky, DM-sugar ok this AM; resolved with juice and crackers BP ...
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patient said "I feel high", appears shaky, DM-sugar ok this AM; resolved with juice and crackers BP 128/70 P 76
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| 73 | 2021-04-23 | anxiety |
On March 2nd woke up with right calf pain. Thought I had a charley horse in the middle of the nigh...
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On March 2nd woke up with right calf pain. Thought I had a charley horse in the middle of the night and thought this was the soarness you get afterward. Because I had been on Crestor for approximately 5 weeks I thought that the crestor may be causing muscle pain. After 2 days of calf pain which was subsiding by then I visited Dr. who ordered a right ultrasound and I had 2 blood clots in the right leg (one in calf and one behind the knee). Due to the fact that I did not meet any standards for getting blood clots I was put on blood thinners (Eliquis) and told to see a hematologist.
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| 73 | 2021-04-24 | excessive sleepiness |
Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; ...
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Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins. The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
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| 73 | 2021-04-25 | panic attack | States it may be a panic attack . Cleared by ems |
| 73 | 2021-04-26 | sleep disorder |
First few days after vaccination had sore arm and headache. By the 4th day the headaches had substan...
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First few days after vaccination had sore arm and headache. By the 4th day the headaches had substantially increased into full-blown migraines. Extreme, debilitating fatigue. Body aches that kept me from sleeping. Pain on right side of head behind ear that felt like I had been hit. Could not do normal housework. April 1 I went to the emergency room where they gave me IV Toradol which alleviated the pain for 2 or 3 days. April 21 I got in to see my PCP. She prescribed a Medrol Dose Pack. Today is my last day of that.
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| 73 | 2021-04-28 | feeling abnormal |
didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; ...
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didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-05-01 | feeling abnormal |
Dizziness started the next day and progressively got severe trying not to bump into things. The diz...
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Dizziness started the next day and progressively got severe trying not to bump into things. The dizziness lasted for a few weeks and progressed into weird feelings in her legs as if they were "jelly". She was losing feeling in them and had trouble walking. She was also progressively losing feeling in her hands and had numbness. On 4/2 she had a bad fall due to her legs totally giving out. She was taken to the hospital and released for bad sprain and bruising. We went to her primary doctor to report her condition also. I asked him to report about her condition and he had no idea what the VAERS database was. A week after the fall she wasn't getting any better. She was losing control of more of her body. On 4/19 an ambulance took her to Hospital and they did tests for a week and couldn't find what it was. When she was transfered to another hospital she was diagnosed with Guillain-Barre Syndrome. She was there for a week and is now in a nursing home and has no ability to walk or use her arms.
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| 73 | 2021-05-04 | feeling abnormal |
one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash;...
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one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash; tingling of the left breast; Foggy different feeling; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of BNT162B2 (Pfizer COVID19, Solution for injection, Lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 15:00 for Covid-19 immunisation. The patients medical history included Breast cancer, thyroid cancer, blood pressure and palpitations. The patient had allergic to Z-pak. The concomitant medication includes Synthroid 150mcg 1 tablet by mouth once a day for thyroid cancer. Relevant Family medical history included Shingles shot, she took one a long time ago, like 10 years ago, it gave her ringing in the ear. She had no other vaccines on the same day on in the 4 weeks prior to the first dose. On 12Feb2021, the patient experienced Foggy different feeling, on 13Feb2021 at 16:00, tingling of the left breast, on 14Feb2021 experienced Left breast hurt, heart palpitations and localized rash described as red with white lumps. She had no ER visit. The outcome of the event foggy different feeling, left breast hurt, and white lumps was recovered, whereas of red rash and heart palpitations it was recovering and for tingling of the left breast it was recovered with sequelae. The patient underwent lab test which included blood work whose results were unknown and TSH with results 0.57. She wanted to know if those AEs are from the vaccine and if she is ok to get the second shot. She felt lightheaded for 20 minutes, in the left breast is where she had cancer and it was in situ in the duct, it had not spread for which she received 8 weeks of radiation. She went to bed and noticed that her breast was hurting in the night, but she was too tired to get up at that point, when woke up and took a shower she lifted the left breast and saw a massive, bigger than pancake, rash. It was on the bottom of the breast and it ran down to the stomach, it also had white lumps on it, this just frightened her. There was severe redness before, but that has started to fade, it was still dark brown right now, like she can see outline, but it was going away. Before when there was redness, she could press the spot and it would turn white, it would be red again. When read the instruction that came it says there could be a side effect of a rash, but it would be all over the body not localized. She does not know if the vaccine was responsible for it. Then just quickly she started having heart palpitations on Sunday, just a few, but on Monday it was like a 100 of them. She called doctor, at this point that she also has a history of thyroid cancer in 1982, they removed 2/3rds of her thyroid and since then she has been on Synthroid. When her thyroid was not working properly, she had a TSH done. She got lab work done just to see if it was the thyroid. The doctor said it could be from the shot. The Heart Palpitations were fading, she stopped taking Synthroid for 1 day and it went from 100 palpitations to 50, to like 6-7 now. The heart palpitations were going away and that was after stopping the Synthroid for 1 day. The Light headedness only lasted for 20 minutes but started 5 minutes after getting the shot. She clarified that it was not lightheadedness she means to say that she was a little foggy and had a different feeling. The tingling in the Left Breast began, it was for a couple hours, she thought it was different. Normally she doesn't have that. She has had 6 breast operations, so she has very little feeling in that breast normally. Her left breast began to hurt when she was sleeping, she was too tired to get up and look, she rolled over felt something was wrong. This was at 2-3AM on and it subsided when she took shower and patted all around, she dried it and kept an eye on it, the pain started to go away easily. She did notice that she started to feel a little bit of an itch, but that went away quickly too. She had the rash and lumps, it was during the shower she lifted the breast and saw it. She has a picture to provide. It is Not ongoing, it has started to fade, it is still dark reddish brown, but she can tell it was going away. The heart palpitations started late at 4 or 5 in the evening, she has not had that for years. She knows at one-point TSH was high, but they like to keep it low like this in which the 1/3 of thyroid stays dormant, this is intentional because if it gets too high.
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| 73 | 2021-05-11 | amnesia, confusional state |
Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inab...
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Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inability to communicate- both expressive and receptive, moaning and complete loss of awareness. The initial episode lasted approximately 4 hours. These episodes repeated for the next 3 days. She was taken to the Emergency Room by ambulance 3 days after the vaccine and a workup was completed. It was negative at the time of exam. She did have a mild anemia, but CT and laboratory work were otherwise negative. She had recovered strength and her memory. Later that evening she was again unresponsive except to painful stimuli and was like that over night. She was fatigued but was repulsive the next day. She never gained her full strength back. Over the next 4 weeks, she had progressively more of the periods of unresponsiveness and amnesia that stayed progressively longer and recovery was even less in-between the periods of unresponsiveness. She was placed on Hospice Care and succumbed on March 9, 2021, 1 month after her first vaccine.
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| 73 | 2021-05-11 | feeling abnormal |
brain fog; couldn't keep eyes open; sore shoulder; This is a spontaneous report from a contactable c...
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brain fog; couldn't keep eyes open; sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: unknown) via an unspecified route of administration, administered in Arm Left on 24Jan2021 16:00 (at the age of 73-year-old) as SINGLE DOSE for covid-19 immunization. Patient not pregnant at the time of vaccination. Medical history included hypothyroid and allergies to latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin d3; calcium; iron and thyroid meds. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Jan2021 at 14:00, 24 hours after shot, the patient experienced brain fog, couldn't keep eyes open, sore shoulder, the runs. The seriousness criteria reported was non-serious. The Patient did not received treatment for the adverse events. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested. Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 73 | 2021-05-24 | abnormal behaviour, memory impairment |
Approximately 3-4 weeks after receiving 2nd vaccination, she developed personality changes consistin...
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Approximately 3-4 weeks after receiving 2nd vaccination, she developed personality changes consisting of memory difficulties and progressing to symmetrical, ascending lower extremity weakness and associated diarrhea. Ultimately she was hospitalized with profound hyponatremia sodium of 115, new onset anemia hemoglobin of 9 and progressive thrombocytopenia as low as 15k.
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| 73 | 2021-05-25 | feeling abnormal |
Was awakene by a sharp, shooting pain in my head. These shooting pains continued sporadically, but ...
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Was awakene by a sharp, shooting pain in my head. These shooting pains continued sporadically, but did not stop throughout the next day. I did not time them but at least every five minutes they would come and jolt me. About halfway thru the day 5/25/21, I took a 5. xanax and a tramadol and they subsided, however the sharp searing, shooting pains started up again in the later evening, probably when the meds wore off. It is a sharp quick jolting pain almost electrical in the way they feel. Also had brain fog and sporadic fever of 99.2 and sweating. I usually run around 97. something. Today is Wednesday 5/26 and still have the sweating and slight brain fog and sporadic low grade fever that comes and goes. It is now 6:51 and the pains have seem to have subsided, thankfully.
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| 73 | 2021-05-26 | confusional state, sleep disorder |
Post the Second Dose Following symptoms started to show-up - Tiredness, Confused state of mind, Loss...
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Post the Second Dose Following symptoms started to show-up - Tiredness, Confused state of mind, Loss of appetite - Lack of Sleep - Fluid accumulation and swelling in legs, face/eyes - Increased Creatinine, Reduced Hemoglobin, Vitamin and Iron Deficiency
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| 73 | 2021-06-01 | feeling abnormal |
Weird feeling; Getting sick; Chills; Had joint pain and a headache; Had joint pain and a headache; L...
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Weird feeling; Getting sick; Chills; Had joint pain and a headache; Had joint pain and a headache; Light ache; Fever/temperature started out at 99.9 and went up to 101; This is a spontaneous report from contactable Female consumer via Pfizer-sponsored program. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9265 and expiration dates were not reported), via an unspecified route of administration in left arm on 01Feb2021 at 11:20 as first dose, single for COVID-19 immunisation. The patient medical history included Asthma and it was ongoing and arthritis and she has it in her neck as well. The concomitant medication included Symbicort as long lasting nasal spray, Fexofenadine and Nasacort for asthma and Vitamin For unknown indication from an unspecified date. The reporter reported patient had her first vaccination of the shot on 01Feb2021. She has had side effects since getting the vaccine starting on Thursday. She mentioned she still has fever today and stated it seems long to have a fever, but she wants to know when is too long to have a fever. She had tried to contact her doctor to ask questions about the scale of how long the symptoms can last. She stated she was having more symptoms that most people were; no additional details provided. The doctor's office told her she needed to contact the place where she got the shot for her questions. Patient stated she may have had a fever somewhat on 05Feb2021, but she was not fully aware of it until 06Feb2021. Her temperature started out at 99.9 and went up to 101. This morning it is back to 99.9. she further explained she felt a little weird, had a little ache throughout her body on Thursday, clarified as 04Feb201. This let her know and alerted her that she was getting sick. On Friday 05Feb2021 she started to have joint pain and headache. At first she was not sure what was happening. She mentioned she already has arthritis and she has it in her neck as well. She did not know if it was technically from the arthritis or the vaccine, but she was taking it occurred from the vaccine. She later added that while on Friday she noticed the headache/head hurt, she also hurt everywhere she has arthritis, joint pain. This resolved on its own. She also added she had chills and this was on 06Feb2021. She felt some during the day, but she noticed it mostly during that night. The following morning 07Feb2021 her temperature was 101 and then it dropped again this morning. She stated she took Tylenol. On Thursday, she had something she cannot fully describe what it was, just a weird feeling. When she starts to get sick it is like a wave going through her body; she can tell when she was getting sick. The patient underwent the lab test for body temperature that was 101 on 04Feb2021 and come down to back to 99.9 on 05Feb2021. The outcome of the event Light Ache recovered on 04Feb2021, Chills, Headache and Joint Pain was recovered on 06Feb2021 and the outcome of the event Getting sick and Weird feeling was unknown and Fever was not recovered. Follow up (08Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported that: The information about the patient, new event, event onset and outcome, concomitant products were updated in the case. Follow-up attempts are completed. No further information is expected.
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| 73 | 2021-06-07 | insomnia |
Diarrhea; Left cheek was all red, my arms were red and the bottom of my legs, now usually the bottom...
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Diarrhea; Left cheek was all red, my arms were red and the bottom of my legs, now usually the bottom of my leg that happens because I have lymphedema in my leg but the bottom of my leg are swollen; Left cheek was all red, my arms were red and the bottom of my legs, now usually the bottom of my leg that happens because I have lymphedema in my leg but the bottom of my leg are swollen; now usually the bottom of my leg that happens because I have lymphedema in my leg but the bottom of my leg are swollen; Hand aren't cold; During the night I had the chills, I was burning; During the night I had the chills, I was burning; Could only sleep for an hour, so wake up an hour or so and wake up; Rash and that was very itchy; Rash and that was very itchy; Very tired and mushy mush; Felt very lethargic; Very tired and mushy mush; Felt very lethargic; Arm hurt and it hurt up to my neck; Arm bothered me and it went in to my neck; Arm hurt and it hurt up to my neck; Arm bothered me and it went in to my neck; This is a spontaneous report received from a contactable consumer (Patient). A 73-year-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 25May2021 at noon time (Batch/Lot Number: EW0183) as 1st dose, single dose for covid-19 immunization.Medical history included hypertension, ongoing diabetes mellitus and atrial fibrillation. Concomitant medications included metformin (METFORMIN) 500 mg, 2x/day taken for diabetes mellitus, metoprolol succinate (TOPROL XL) 100 mg, 2 Tablets in Morning and 2 Tablets at night, diltiazem (DILTIAZEM) 180 mg, 2x/day, furosemide (FUROSEMID) 40 mg, 1x/day, losartan (LOSARTAN) 50 mg, 1x/day, 1 tablet a day, atorvastatin calcium (LIPITROL [ATORVASTATIN CALCIUM]) 20 mg, 1x/day, ergocalciferol (VIT D) 1000, 2x/day, blood thinner :dabigatran etexilate mesilate (PRADAXA) 150 mg, 2x/day and nitrofurantoin (NITROFURANTOIN) 100 mg, 1x/day for 10 days. On 25may2021, the patient received the Pfizer shot and was fine all day on tuesday and on 26May2021 (Wednesday) patient was like very tired and mushy mush, her arm hurt and it hurt up to my neck, so she took it easy all day Wednesday and got up Thursday fine. On 27May2021 and 28May2021, the patient was perfectly fine and then when she went to bed last, well other than that she had that rash going on and actually she should say that she had the rash and that was very itchy and that was thursday and fridays and the cream that she had taken by doctor had given her a while back she used that and that subsided the itching. The patient got up friday fine and last night on 28May2021, during the night patient had the chills, she was burning. The patient do have and do had a rash but it's a rash that had gotten before and used the medicine that that doctor had given her and it had taken it, it had cleared it away, so she know on the directions here it says about a rash. And so when she got up this morning on 29May2021, she have some diarrhea and when got up this morning actually she got up during the night and was like maybe it's my diabetes. So patient had some orange juice in water and went back to bed but she could only sleep for an hour, so wake up an hour or so and wake up. When patient got up this morning i.e on 29May2021, the left cheek was all red, my arms were red and the bottom of my legs, now usually the bottom of my leg that happens because patient have lymphedema in her leg but the bottom of her leg are swollen. So now as the morning has gone on things are subsiding her hand aren't cold anymore and she was feeling better. The patient reported, that was Clotrim/ Beta CRE Diprop and that's topically applied twice a day but she have only done it once a day on the last 2 days, Thursday and Friday (further clarification unknown) and also she told that on 28May2021 was her last day on 10 days of antibiotic, that's Nitrofurantoin and that's a 100 mg and that was one a day, no twice a day for 10 days and yesterday was the 10th day.The outcome of events insomnia, diarrhea , burning sensation , chills ,temperature regulation disorder, peripheral swelling, lymphoedema, erythema was resolving and outcome of rash, neck pain , pain in extremity (arm), lethargy , fatigue, pruritus was resolved in may2021
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| 73 | 2021-06-07 | insomnia |
fell on the floor; Very strong malaise feeling; Was sore all over, whole body sore, from toes right ...
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fell on the floor; Very strong malaise feeling; Was sore all over, whole body sore, from toes right up to hair; Freezing cold; Very tired; Couldn't get to sleep; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on 01Feb2021 11:00 (Batch/Lot Number: EN5318) as 2st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration in right upper arm on 11jan2021 on (Lot no: EL3246) as single dose for covid-19 immunization. On 02Feb2021 at midnight 01:00 Am 13 hours after the vaccination patient woke up at 1AM with a very strong malaise feeling and was sore all over her whole body was sore from her toes right up to her hair, and she was freezing cold. She could not lay in bed comfortably as patient was very tired and could not get to sleep. This condition lasted until 10AM, she got up at 9AM, she had a terrible time and fell on the floor. Patient took Tylenol 650mg, that that kicked in about a quarter of an hour, and she felt better, but it was the whole day, she took another dose on that evening. the whole day she was dead in her tracks, she didn't want to get up and walk but she wasn't in bed. Malaise went away until the end of the day, might be at 10-11PM, also reported that all these reactions diminished gradually until they were nothing, all probably equal. She has recovered completely from them all. She was generally a pretty healthy person. She was even healthier now. She wanted to know, why she had no reaction in the first shot, was there sometimes a reaction in second She has gone through so much research, and there is conflicting information, so she thought to reach directly. she doesn't share about the fact she had a reaction to the second. She doesn't want to discourage people from getting the second. Caller reports she lives in an assisted living and she has done a personal survey amongst the residents. Caller reports that about 25% of people have had reactions to second dose, and they are not allergic reactions. Caller mentions because the word was getting around the residents have had more of a reaction to second dose, some residents are choosing not to get the second dose. Caller mentions she has found some information on website. The outcome of the events was recovered on 02feb2021. Follow-up attempts are completed. No further information is expected.
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| 73 | 2021-06-09 | mental status changes |
Admit 5/25 for AMS and UTI. Rapid COVID+, 2 subsequent COVID PCRs negative but not ruled out as per ...
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Admit 5/25 for AMS and UTI. Rapid COVID+, 2 subsequent COVID PCRs negative but not ruled out as per documentation. Treated with Zinc and Decadron. Remains admitted at time of review 6/7/21, to be transferred to another hospital.
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| 74 | 2021-01-14 | abnormal dreams, confusional state |
Resident had severe confusion. She thought she was in another state and that we were all strangers. ...
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Resident had severe confusion. She thought she was in another state and that we were all strangers. She has a decrease in her appetite and an increase in thirst. She complained of low back pain with aches all over her body. She also stated that she had very vivid dreams. this is not at all the typical behavior that we have seen in her. Previous labs were checked and all were within normal range.
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| 74 | 2021-01-15 | feeling abnormal | Sore arm that day (1/14) which is normal. Brain fog the following morning for 4 to 6 hours. |
| 74 | 2021-01-21 | sleep disorder |
As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my...
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As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my body was on fire. Also add headache could not hardly stand to lay my head on the pillow. About 4 AM I could not tolerate the situation any longer and took 600 mg of Tylenol. After that was able to rest some. The next day after the vaccination my joints were achy moderately and I have a headache. The injection site was tender to the touch and arm range of motion decreased and arm sore. Took 400 ibuprofen about 4 PM day after injection to ease Reactions
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| 74 | 2021-01-24 | anxiety |
Slight numbness in the left cheek (face) down into the left arm, increased anxiety, Pt vitals checke...
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Slight numbness in the left cheek (face) down into the left arm, increased anxiety, Pt vitals checked and 1 25mg of Benadryl given PO, Pt rested approx. 2 hours before she felt comfortable to leave
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| 74 | 2021-01-24 | confusional state |
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ...
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Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
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| 74 | 2021-01-27 | feeling abnormal |
Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday m...
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Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday morning
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| 74 | 2021-01-27 | sleep disorder |
Pain (level 4 of 10) starting in right rear of neck, becoming more intense on 01/19/21. By evening h...
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Pain (level 4 of 10) starting in right rear of neck, becoming more intense on 01/19/21. By evening head movement was very difficult, I could not sleep in bed that night. I slept on the couch sitting up trying to immobilize head. During the night pain spread into the base of my skull. I applied heat to help relieve the pain and tightness. On 01/20/21 the pain (6 of 10) spread into the left side of neck and skull, it became difficult to eat, swallow and to get up from couch. I tried to sit motionless most of the day. On 01/21/21 the pain (6 of !0) moved down into my left rear shoulder, I continued to apply heat and immobilize sitting on couch, eating and swallowing still difficult. On 01/22/21 pain in neck and base of Additional information for Item 18: skull subside to level 5, movement of head still difficult, able to to get up and move slowly. Could not lift head to drink, still needed to use straw. Slept on couch again this night. On 01/23/21 pain still subsiding to level 4, head movement still difficult, still needed straw to drink, slept on couch again. On 01/24/21 pain continuing to subside to level 3, head movement still difficult, still needed straw to drink, slept on couch again. On 01/25/21 conditions unchanged. On 1/26/21 pain subsided to level 2, head movement stiff but not difficult, swallowing less difficult but still need straw to drink. Slept in bed for first time since 01/19/21. On 01/27/21 pain continued to subside to level 1, head movement improved but still limited, still need straw to drink, able to move around more freely but still not normal. Improvement is slow but I hope to be back to normal in a few days. I am concerned that my second vaccination may cause a more severe reaction, please have someone call or contact me so I can discuss this issue.
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| 74 | 2021-01-28 | sensation of foreign body |
15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the...
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15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the right side of my throat. I was monitored in the ER, seen by the doctor and given 25 mg of Benadryl. My BP was high. I was discharged after approximately an hour and a half after incident. THESE WERE MILD SYMPTOMS. I was told to take Benadryl for the next 48 hours, which I did.
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| 74 | 2021-01-28 | sleep disorder |
it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; ...
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it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.
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| 74 | 2021-01-30 | sleep disorder |
Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body ac...
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Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body aches and chills. Left arm sore for three days.
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| 74 | 2021-01-31 | sleep disorder |
exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; so...
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exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; sore left eye; blood pressure very high and hard to control; shingles; This is a spontaneous report from a contactable consumer. A 74-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 08Jan2021 13:30 at single dose for covid-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, neuropathy peripheral, asthma/allergies, headache, allergy to medications, food. Concomitant medications included azelastine, fluticasone propionate (FLONASE), metoprolol, gabapentin, levothyroxine sodium (LEVOTHYROXINE). The patient experienced shingles on 08Jan2021 (immediately after she got the shot), exhausted on 09Jan2021 03:30, slept most of day/night on 09Jan2021 03:30, pain in scalp, pimples, bumps on 09Jan2021 03:30, sore left eye on 09Jan2021 03:30, blood pressure very high and hard to control on 09Jan2021 03:30. Patient was treated with Valacyclovir, lisinipril, metropolis, aquafor. The outcome of shingles was unknown. The outcome of exhausted, slept most of day/night, pain in scalp, pimples, bumps, sore left eye, blood pressure very high and hard to control was not recovered.
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| 74 | 2021-02-01 | amnesia |
Client report having adverse reaction on 02/01/2021 at 12:28 about one hour after receiving COVID va...
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Client report having adverse reaction on 02/01/2021 at 12:28 about one hour after receiving COVID vaccine of unable to remember running a red light. She report loss of visual memory and no recall of passing through the intersection or seeing the buildings on the corners. Denies having blurry vision, blacking out, slurred speech or headache. Client had a virtual doctor visit and drove to have labs drawn today without issues.
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| 74 | 2021-02-01 | mental status changes | Altered mental status; Chest pain; Elevated troponin; Generalized weakness |
| 74 | 2021-02-01 | sleep disorder |
No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling u...
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No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; arthritis; she can't go to sleep until 1 am/unable to sleep/She can go to sleep at the drop of the hat in the afternoon which is not usual; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 15Jan2021 14:15 at single dose on the left deltoid (also reported as "left arm") for COVID-19 immunization (reported as "Prevention"). Vaccination facility type was retirement community, not a military facility. Medical history included "blood pressure", reflux (her esophageal flapper bottom is deteriorated), blood disorder (reported as indication of aspirin: "blood thinner") and depression. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID) as a blood thinner, citalopram hydrobromide (CELEXA) for depression, hydrochlorothiazide for blood pressure, omeprazole for reflux (It is because her esophageal flapper bottom is deteriorated) and multivitamin; patient reported that she was taking all prior to the vaccine and did not think any were relevant to the report. There were no previous vaccine (reported as "Additional Vaccines Administered on Same Date of the Pfizer Suspect. None"). The patient reported that she got the injection last Friday (15Jan2021). She was still feeling the symptoms of everything with the exception of injection site pain and swelling and redness. She did not have any swelling of lymph nodes or nausea. With the exception of those items listed, she had all the other side effects. On 16Jan2021, the patient experienced tiredness, headache, muscle pain, chills, joint pain and feeling unwell. The patient stated that muscle pain and joint pain could also be attributed to arthritis. Patient mentioned that chills could have been Sunday, but she thought Saturday (16Jan2021). Patient did not have a fever. Patient also mentioned that unable to sleep was a chronic problem. She can go to sleep at the drop of the hat in the afternoon which was not usual. Then at night, she could not go to sleep until 1 am. She did not wish to list this as a side effect and did not feel it was attributed to the vaccine. No energy has been really bad today (19Jan2021), but she still thinks it was persistent. Patient will get another dose in 3 weeks. No emergency room (ER) or physician's office required. Patient wanted to know if it was common to get these side effects. Outcome of the events tiredness, headache, muscle pain, chills, joint pain, feeling unwell and No energy was not recovered while for other events was unknown. There was no investigation assessment. Information on the lot/batch number has been requested.; Sender's Comments: The reported insomnia is considered unrelated to BNT162B2 administration since mentioned as a pre-existing condition
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| 74 | 2021-02-03 | feeling abnormal, impaired work ability |
she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; ...
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she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
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| 74 | 2021-02-03 | feeling abnormal |
I had significant vertigo lasting 5 days. This is on the CDC list to ?call your physician?. I was n...
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I had significant vertigo lasting 5 days. This is on the CDC list to ?call your physician?. I was not dizzy-by definition but vertiginous -trying to turn over in bed made my head feel like it was spinning. I think this is much more common than reported. As a physician in the community people frequently reach out to me for advice and I have been told several times about serious vertigo in elderly people with new onset after Covid immunization. I have no intention to delay or abort my second dose. My only current symptoms is fuzzy headedness that is sporadic. The elderly might need to be warned about this and advised accordingly-re not to drive etc. i am former physician and after TNTC immunizations in the past this was unique.
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| 74 | 2021-02-04 | anxiety |
Patient felt cold, some shortness of breath right after vaccine. Experienced anxiety too. Given wate...
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Patient felt cold, some shortness of breath right after vaccine. Experienced anxiety too. Given water and apple juice - felt better and was discharged to home. Vitals: 168/96, 162/86 (pulse 68). O2 sat 100%.
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| 74 | 2021-02-07 | feeling abnormal |
Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning...
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Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization. Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 74 | 2021-02-07 | insomnia, restlessness |
Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Un...
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Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form! Can I take Benadryl? I had none of these adverse effects with 1st dose!
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| 74 | 2021-02-10 | sleep disorder |
First I got the shot on the 3rd, that Saturday I ate breakfast and I got sick as a dog. I threw up m...
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First I got the shot on the 3rd, that Saturday I ate breakfast and I got sick as a dog. I threw up my whole breakfast. I have been throwing up every day since that day, every day and every thing I eat comes right back up. I can't keep any food in my stomach. I've got headaches, I've never had a headache in my life until I had these. The headaches are unbearable. I have not had a bowel movement since I had the virus and that's been how many days? Many. I can't sleep, I'm sick. I feel like heck, I'm scared to eat because everything I eat comes back up. I can hardly drink anything because I am diabetic, I barely drink any water. I'm a mess.
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| 74 | 2021-02-11 | feeling abnormal |
Patient states Fuzzy, light headed, head feel heavy like she wants to go to sleep. BP 156/78, report...
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Patient states Fuzzy, light headed, head feel heavy like she wants to go to sleep. BP 156/78, reports she needs fresh air, feels claustrophobic. RN took the patient outside, took her mask off and started feeling better. NO SOB no respiratory distress, denied pain. Patient education provided and instructed to call her PCP asap for appointment.
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| 74 | 2021-02-12 | feeling abnormal |
Pfizer-BioNTech COVID-19 Vaccine EUA Received shot at 11:10 am. I felt fine all day but at 2am the...
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Pfizer-BioNTech COVID-19 Vaccine EUA Received shot at 11:10 am. I felt fine all day but at 2am the next morning I woke with a fever, headache and felt terrible. Fever of 101 degrees lasted all day. I took Tylenol twice. Went to bed that night with 100 degree temperature. Woke next morning with no fever and only a slight headache but am eating now and feel lots better.
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| 74 | 2021-02-17 | feeling abnormal |
Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kid...
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Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.
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| 74 | 2021-02-17 | loss of personal independence in daily activities |
3 hours after injection, I noted sensation of throat tightening (no breathing problems) and headache...
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3 hours after injection, I noted sensation of throat tightening (no breathing problems) and headache, throat symptoms eased after an hour. Few hours later I noted gradual increase in muscle and joint ache, no increase in body temp. and sudden onset of fatigue. I am a very active person - playing tennis 3 - 4x/wk, hiking 4 - 6 miles twice a week, biking, dancing, etc. Most symptoms subsided within 24 hours, but fatigue still persists on the third day following the injection. Had to stop normal activity, less fatigue but still need to stop after 20 minutes of standing or walking to sit and rest,
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| 74 | 2021-02-18 | anxiety |
Attended vaccine clinic with friend. After receiving vaccine and moving to observation area, pt repo...
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Attended vaccine clinic with friend. After receiving vaccine and moving to observation area, pt reports noticing? her mouth feels numb and tingly?. Pt has history to surgery for non-cancerous tumor on skull that involved the nerves in the early 2000s resulting in facial asymmetry and some swelling and redness around her left nares. Face inspected and her friend reports that it looks normal for her. Facial asymmetry continues but when assessing face, her friend reports the asymmetry is her norm. VSS BP 166/108, HR-68, Resp 14. She reports that BP goes up. She has no side effects with the first dose but reports feeling ?extremely anxious about coming to get this vaccine?. Arm and leg strength are equal bilaterally. Pt drank water and says she is feeling better by 2:42. She reports no longer feeling tingly but her lips are still numb> 2:52 symptoms resolved with no additional symptoms reported. 3:01 no further s/s reported. Reviewed s/s of reactions vs side effects. Agrees to notify PCP of response after vaccine and also agrees to call 911 with any s/s reaction upon leaving Facility.
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| 74 | 2021-02-18 | crying |
PHN called to 15 minute observation post-immunization by Nurse and Nurse who were with px upon PHN a...
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PHN called to 15 minute observation post-immunization by Nurse and Nurse who were with px upon PHN arrival at 9:50am. Px found to be cool to the touch, crying yet unresponsive; px was unable to verbalize or open her eyes. Respirations were even and non-laborious, rise and fall of chest was visible. VItals monitor brought to scene, Fireman/Paramedic called to scene and 911 called. BP: 161/111, SpO2:95% RA, HR: 80. Husband brought to scene to provide medical Hx information. Hx of High Blood Pressure confirmed with husband, Hx of Diabetes denied by husband. EMS Arrived at 9:56am, blood glucose checked and recorded at 199. PHN rechecked vitals at 09:57am , BP: 143/89, HR:81, SpO2: 95%. EMS advised px received first dose of Pfizer immunization at 9:36am. Px taken to Hospital for further medical work up at 10:08am via ambulance.
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| 74 | 2021-02-18 | feeling abnormal |
Dizzyness immediately after taking vaccination lasted 2-3 days Brain fog within thirty minutes of v...
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Dizzyness immediately after taking vaccination lasted 2-3 days Brain fog within thirty minutes of vaccination - lasted two days Severe headache for three days (took 2 tylenol every 6 hours for 3 days) balance problems the morning after the vaccination cough (only lasted two days) fatigue and achiness for about three or 4 days soreness at vaccination site (for several days)
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| 74 | 2021-02-23 | sleep disorder |
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sle...
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12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
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| 74 | 2021-02-25 | fear |
I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM...
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I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM I went to bed because I didn't feel good, I laid in bed for a few minutes and then jumped up because I began to violently vomit. After I vomited I felt weak, I was sitting with my back against the wall my husband came to check on me. He walked away and when he came back I was unresponsive, laying on the floor and he said my eyes rolled in the back in of head. He called 911. I was unresponsive for about a 1-2 minutes. EMS arrived, by the time they had arrived I had crawled into bed, and they took my vitals and they were fine, they asked me if I wanted to go to the hospital but I declined as I was afraid to go. I went to sleep. The next day I felt weak and tired, I had a burning feeling in my stomach, I took some TUMS, I didn't much that day. I rested most of the next day. Yesterday I felt a little better and today I am fine. I have a doctor's appointment 2/26/2021 at 2PM to see the ARNP at my doctor's office.
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| 74 | 2021-02-25 | feeling abnormal |
still a part of her forehead that feels like a live nerve; upper back started hurting/back was very ...
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still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown. The information on the Batch/Lot number has been requested.
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| 74 | 2021-02-26 | insomnia, feeling abnormal | Itch at site, sore arm, insomnia, brain fog, out of breath |
| 74 | 2021-02-28 | anxiety |
Approximately 10 minutes after receiving the vaccine, patient reported muscle tightness up through h...
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Approximately 10 minutes after receiving the vaccine, patient reported muscle tightness up through her left shoulder into her neck. She was extremely anxious. Her initial blood pressure was 190/100. She reported being extremely scared of coming to the clinic today for the vaccine and that she got no sleep the night before. We talked extensively and I tried to get her mind thinking about anything else possible. Repeated her BP after a time and it was 142/82. Once her required 15 minute observation was over, she requested to leave, because part of her apprehension was just being there. Her neck tightness has subsided.
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| 74 | 2021-02-28 | anxiety |
rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitatio...
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rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone. She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
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| 74 | 2021-02-28 | loss of personal independence in daily activities |
L arm weakness, pain, L anterior Chest wall tenderness onset later that afternoon. worse with moveme...
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L arm weakness, pain, L anterior Chest wall tenderness onset later that afternoon. worse with movement, couldn't get dress herself afterwards
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| 74 | 2021-03-02 | feeling abnormal |
Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a ...
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Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a spontaneous report from a contactable nurse (patient herself). A 74-year-old female patient BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN5318, Expiry date: 31May2021), via an unspecified route of administration on left deltoid, first dose on 30Jan2021 13:30 at single dose for COVID-19 vaccination. Medical history included condition on thyroid from an unknown date and unknown if ongoing for thyroid. Concomitant medication included levothyroxine. Patient had given her side effects. She had her vaccine 2 days ago (30Jan2021 13:30). She have had fogginess and have been nauseated, light headache and just not feeling, general malaise, all on an unspecified date in 2021. Due date of Second Vaccine was on 20Feb2021. Treatment in response to the event was trying to get liquids and rest. She got the vaccine at an hospital. Patient had a thyroid test, CBC test and a CMP, they are all normal and had COVID test that was negative on unspecified dates. The action taken in response to the event was unknown.
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| 74 | 2021-03-02 | feeling abnormal |
my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not bre...
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my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100°F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious. Information on the batch/lot number has been requested.
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| 74 | 2021-03-02 | poor quality sleep |
light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen...
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light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.
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| 74 | 2021-03-03 | anxiety |
Pt developed circumoral paresthesia (tingling of her lips and tongue) shortly after injection into r...
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Pt developed circumoral paresthesia (tingling of her lips and tongue) shortly after injection into right deltoid without shortness of breath, chest pain, rash, sore throat, hives, myalgias, nausea, or vision changes. She reports feeling anxious regarding the crowded atrium while getting her shot. Patient symptoms improved after monitoring for 30 minutes with stable vital signs without administration of medications.
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| 74 | 2021-03-03 | feeling abnormal |
Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right...
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Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.
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| 74 | 2021-03-03 | feeling abnormal |
post vaccine patient complained of dizziness, had an extra 15 minutes of rest, felt no better and co...
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post vaccine patient complained of dizziness, had an extra 15 minutes of rest, felt no better and complained she felt out of it.
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| 74 | 2021-03-04 | feeling abnormal |
The patient was at the end of her 30 minuet observation post IM injection. Patient stated, "I feel f...
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The patient was at the end of her 30 minuet observation post IM injection. Patient stated, "I feel funny, my lips and tongue are tingling. My tongue is starting to feel thick." Patient was taken to a private room where vitals were taken ( stable vital signs), patient stated, "I feel like it is getting worse." Patient was given IM EPI. EMS was called and patient was transported to the ED.
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| 74 | 2021-03-04 | sleep disorder |
After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning,...
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After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning, itching, soreness and can't sleep on that side.
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| 74 | 2021-03-08 | anxiety |
pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, ...
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pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety. Pt called ambulance and transported to ER. She was tested for covid w/ negative results. Had blood work w/ abnormal results (mild leukopenia). She was prescribed Benadryl. Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax. She was released and told to FU w/ PCP. Her FU appt is 3/12/2021.
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| 74 | 2021-03-09 | anxiety |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: Dr at 3/1/2021 10:50 AM Ex...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: Dr at 3/1/2021 10:50 AM Expand AllCollapse All COVID VACCINE CLINIC 3/1/2021 Subjective 74 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms and respiratory distress. PMH: currently on ciprofloxacin for an UTI. Past Medical History: Diagnosis Date ? Allergic rhinitis, cause unspecified Allergic Rhinitis; NG PMH ? Allergy ? Awareness under anesthesia Pt was hard to wake when had anes in 1970's ? Carpal tunnel syndrome ? Colon polyps ? Coronary artery disease ? H/O heart artery stent 2005 ? Hearing loss bilateral hearing aids ? Iritis ? Iron deficiency anemia ? Lumbosacral spondylosis without myelopathy ? Osteoarthrosis, unspecified whether generalized or localized, unspecified site Osteoarthritis; NG PMH ? Osteopenia osteopenia, MVA with whiplash injury that caused servical spondylosis 60's, s/p laminectomy 75, 88 ? Other and unspecified hyperlipidemia Hyperlipidemia, Pure; NG PMH ? Pain, chronic ? Peripheral vascular disease, unspecified (HCC) ? Tinnitus ? Unspecified essential hypertension Hypertension; NG PMH ? UTI (urinary tract infection) ? Wears hearing aid in both ears 2017 ALLERGY REVIEW OF SYSTEMS: Patient denies chills, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches, joint pain, dizziness and headaches + lightheaded: Previous Reactions: none Objective Vitals Vitals: 03/01/21 1025 03/01/21 1040 BP: (!) 144/56 132/61 Pulse: 93 70 Resp: 20 14 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not ill-appearing or diaphoretic. Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Mental status is at baseline. Gait: Gait abnormal (walks with a cane. ). Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Observed in the medical bay for approx 15 minutes. Pt responded well with water and rest. She was able to demonstrate ambulation in the bay w/o reoccurence of lightheaded. Pt reports she feels a lot better. Pt encouraged to monitor bp at home and follow up with pcp if noted to be 140/90 consistently. Pt walked out by RN accompanied by pt's husband. Pt voiced appreciation for today's care/visit. APRN Electronically Signed 3/1/2021 10:32 AM
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| 74 | 2021-03-09 | disorientation, disturbance in attention |
Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt be...
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Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt better when I woke up. I haven't felt completely well. On Monday 3/8 I had vertigo and nausea and my arm was sore. I feel disoriented, like I just cant concentrate well. extremely tired, I feel like I could sleep all day.
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| 74 | 2021-03-09 | insomnia |
11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold...
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11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold sweats, severe aching and muscle weakness especially in legs, nauseous, severe headache. I tried to drink a little water. Didn't have enough energy and was too cold to get up to get any medication. Slept a little. I was awake early in the morning, but too cold to get out of bed. At 8:30 a.m. I got up and could hardly walk. Dizzy, muscle weakness as if muscles had turned to Jell-O.. Sat down and threw up, mostly dry heaves, which lasted a few minutes. Fitful sleep until 11:00 a.m. when I began to feel better. Drank more water and just rested for a few hours. I ate some applesauce and made a batch of white rice which I ate around 6:00 p.m. Achiness in lower extremities continued until bedtime (10:00 p.m.) when I took a Meloxicam (15 mg) which my GP prescribed for achiness in my neck due to arthritis. I take this drug only when needed and thought it would help the aching in my legs. Maybe it did...maybe it was a coincidence that the achiness was alleviated enough for me to go to sleep. I am almost 100% today. It takes a little longer at my age to fully recover from any illness however slight. I would like to add that I am grateful to be vaccinated.
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| 74 | 2021-03-10 | anxiety, feeling abnormal |
20 minutes after being vaccinated, patient felt,weak,feeling "I'm going to pass out", facial rednes...
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20 minutes after being vaccinated, patient felt,weak,feeling "I'm going to pass out", facial redness, feeling very hot. Remains alert and oriented x3. Brought to EMT monitoring area, VSS 148/72 HR 57 O2 100%, POC 86, very anxious with husband at bedside. EKG,with heart being monitored all within normal ,noted in database for rate as baseline. Cognitively presents anxious with noting calmness after 30 minutes with patient stating "I just feel not right". Has stated that her throat feeling cold. feeling spacey. Vitals have remained stable and offered to be transported to ER if preferred. Both she and husband agreed to be transported to Hospital. Their son was notified of this episode. Transported in stable condition to Hospital.
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| 74 | 2021-03-10 | nervousness | Dizziness and nervousness; rested and discharged home |
| 74 | 2021-03-14 | disorientation, excessive sleepiness |
lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her fa...
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lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her face/incredible face pain, throbbing; slept most of the two days following the vaccine; face became bright red with swelling and intense in her cheeks and forehead; face became bright red with swelling and intense in her cheeks and forehead; disoriented; dizzy/wooziness; This is a spontaneous report from a contactable consumer herself. A 74-years-old female patient started to receive bnt162b2 (Pfizer-Biontech covid-19 vaccine, Solution for injection lot number: EN5318 and expiration date: unknown) intramuscularly from 29Jan2021 18:10 at single dose for prevent covid. Medical history included stroke from Apr2018 to an unknown date since she had a stroke 3 years ago. Concomitant medication included rivaroxaban (XARELTO) for stroke 30 mg, once a day. The patient previously took diphtheria vaccine. Caller states she spoke to safety agent and gave them all of her information. Caller states she received the first dose of the Pfizer COVID vaccine Friday at 6:15 pm. Caller states after waiting the recommended 15 minutes at the vaccination facility after receiving the first dose caller states four minutes later she began to experience lower jaw numbness that lasted a few seconds 29Jan2021. Caller states her face became bright red with swelling and intense in her cheeks and forehead In Jan2021. Caller states these symptoms were only in her face and no where else. Caller states she was taken back to the vaccination facility and the nurse monitored her every ten minutes for about 30 minutes until she cooled down and then she was sent home. Caller states during this time she was disoriented and dizzy In Jan2021. Caller states the next day she experienced pain in her face and to this day she still gets some pain but no more redness in her face. Caller states she is scheduled for the second dose on 19Feb2021. Caller states she read somewhere online that if you had a severe allergic reaction to the first dose you should not receive the second dose. She stated that within roughly five minutes of receiving the vaccine that she began to experience a numbing in the chin and the surrounding area. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She also experienced wooziness and a dizziness. She said the experience subsided in approximately 40 minutes of its onset. She is scheduled to receive the second dose on the 19th of Feb, but has some concerns about receiving it due to her experience. The patient had Fatigue, Headache in 29Jan2021. She clarifies her slight headache pain came back with the fatigue, reports it comes and goes. Her headache is off and on. After about 5 minutes of waiting she felt a little numbing in her jaw on the right side. Then 2 minutes later her face got bright, bright red, like there was real heat coming from it. She also had swelling in her face. It was very strange. She is asking if it is safe to get the second dose which is scheduled for 19Feb2021. This reaction lasted about 40 minutes. Her face was all flushed and burning hot red. It took a couple of hours for her face to come back to her normal color. After this faded, she reports she was left with incredible face pain, it was throbbing. She was extremely fatigued and is still fatigued, she can do very little. She is managing to cook. She slept most of the two days following the vaccine. The outcome of the events Numbness recovered on 29Jan2021,red face recovered in 2021, event pain in her face/incredible face pain, throbbing recovered in 31Jan2021, event Fatigue was recovering and other events unknown.
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| 74 | 2021-03-15 | feeling abnormal |
Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/f...
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Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/feeling odd, along with the shakes and chills. VS taken and doctor notified of patient arrival. Reviewed Pt. History and any medical problems. Pt stated she is currently being treated for Sinus Problems and saw her doctor yesterday who encouraged her to get her vaccination today. She is on a Prednisone taper, and takes HCTZ for BP, and had a cardiac procedure done last year for chest discomfort, and nothing was found. Discussed with doctor the need to call EMS. Pt resistant to this but explained that they would assess her and then she could decide what kind of treatment from there. Pt still resistant to having EMS called, but call placed as per protocol. EMS Arrived and report given. Pt still resistant to being transported to hospital, after approx 15 minutes EMS convinced patient of the risks and needs of being transported versus the risks of driving there herself. Pt transported via EMS hospital.
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| 74 | 2021-03-17 | anxiety |
Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07...
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Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07/20/2021. Patient appeared anxious about receiving vaccine but was alert and oriented x4 and ambulatory with no other complaints. No previous reactions to vaccinations per patient. Patient received Covid vaccine at 1002, patient started coughing and complaining of chest tightness at 1005 with auditory wheezing. First Epi given at 1005 and O2 was placed on patient via face mask at 15L. 911 was then called. O2 saturations at beginning of reaction in the high 80's and dropping, HR 150's. Unable to obtain blood pressure throughout episode at clinic. IV access attempted and unsuccessful x1 at clinic. Saturations continued to drop into low 70's with no improvement of respiratory symptoms. Decision was made to give second Epi and was given at 1010. Before second attempt to establish IV access EMT arrived. Patient was transferred to stretcher and taken to Ambulance via EMS staff.
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| 74 | 2021-03-17 | feeling abnormal |
caller states that his mother has become increasingly more tired, has a fever of 102, c/o chills, fe...
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caller states that his mother has become increasingly more tired, has a fever of 102, c/o chills, feeling dehydrated. Tingling in legs and feeling unsteady on feet. Was working in garage earlier today however had to lay down due to fatigue. Caller gave his mom 2 tylenol approx 20 min prior to calling, reports that he feels that is helping. Reports that she is A/Ox3 just "tired". Advised to increase fluids and monitor fever and effectiveness of tylenol. If she doesn't improve in the next hour, or if she begins to experience any chest pain, SOB or neuro changes, caller needs to take her to contact her PCP and/or ER. Spoke with son, his mom is doing much better, no fever and symptoms have resolved.
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| 74 | 2021-03-17 | hallucination | hallucinations with high fever lasting about 36 hours |
| 74 | 2021-03-17 | memory impairment |
Became ill two days after vaccination, slight fever , nausea, headache, forgetful , unsteady on feet...
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Became ill two days after vaccination, slight fever , nausea, headache, forgetful , unsteady on feet , sleepy
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| 74 | 2021-03-17 | nervousness | Slightly lightheaded, nervous. BP 175/96 (pulse 81), 169/98 (pulse 78). O2 sat 100%. |
| 74 | 2021-03-18 | disorientation |
Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient ...
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Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient has hx of throat swelling from PO Sulfa. Pt alerted nurse at 9:35AM that she was experiencing a generalized prickle sensation. P60 O2RA 97%. At 09:54AM pt experiencing widespread prickle sensation, tightening in throat, difficulty swallowing, disorientation, and light headedness. Epi 0.3mg auto injector(Lot 0FM534) administered left leg 9:54AM per RN; BP 198/72 P75, O2RA 98%. EMS called 9:55AM, arrived at 9:59AM and assumed care of patient. Patient transported to Hospital.
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| 74 | 2021-03-18 | fear, excessive sleepiness |
Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; ...
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Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; no appetite; Not feeling well; still tired; sleeping a lot; Very fearful of taking the second shot; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Lot Number: EM0910) as single dose for covid-19 immunization. Medical history included mild chronic obstructive pulmonary disease, asthma, bronchitis, sinus infection and sulfa allergy from unknown dates. The patient previously took and experienced allergies to acetaminophen, montelukast sodium, hydroxyzine, budesonide-formoterol fumarate and pseudoephedrine hcl. On 09Feb2021, at 01:00, the patient experienced sore injection site with outcome of unknown; joint aches with outcome of unknown; chills with outcome of unknown; headache with outcome of unknown; nausea with outcome of unknown; vomiting with outcome of unknown; muscle pain with outcome of unknown; listless with outcome of not recovered; fever with outcome of unknown; no appetite with outcome of unknown; not feeling well with outcome of unknown; still tired with outcome of not recovered; sleeping a lot with outcome of not recovered; very fearful of taking the second shot with outcome of not recovered. No treatments were given for the events. Details were as follows: the adverse events included sore injection site, joint aches, chills, headache, nausea, vomiting, muscle pain, listless, fever, no appetite, not feeling well, all in that order. Worst side effects were gone by the third day; she was still tired, sleeping a lot and was listless. The patient was also very fearful of taking the second shot. The events resulted in doctor or other healthcare professional office or clinic visit on an unspecified date.
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| 74 | 2021-03-18 | excessive sleepiness |
she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotte...
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she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: May2021), via an unspecified route of administration in left arm 03Feb2021, at 10:50 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Prediabetes (5 years ago) and obviously overweight and had cat bite. The concomitant medication was not reported. The patient previously took historical vaccine, on an unknown date in Jan2021 (she got the first dose three weeks before on a Wednesday), first dose of bnt162b2 for COVID-19 immunisation and had no reaction. On 03Feb2021 (early evening) the patient experienced a bad headache and was very tired. Caller says where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that. She says she also had muscle aches and pains. The patient took Aspirin (UPC 9629513147, LOT: P115130, EXP: May 2021) for the event muscle aches and pains at a dose of 325mg, one before bed, took three during night total. The patient reported that she slept and slept and slept on an unknown date in Feb2021. It was reported that patient lots of bloodwork done over the years but if she eats correctly it goes away, then if she gets into the sugar, it comes back. The outcome of the events, where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that and she also slept and slept and slept was unknown while for other events was recovered on an unknown date in Feb2021.
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| 74 | 2021-03-18 | sleep disorder |
Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Mon...
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Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Monday, stopped about 24 hours laterTuesday. Started again third night, Wednesday, stopped next morning. Started again Thursday night and is continuing on Friday (today). Secondary starts are not as strong as first night but are still very uncomfortable and do not allow for a good night?s sleep. Have been taking aspirin and Advil.
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| 74 | 2021-03-21 | restlessness, feeling abnormal, insomnia |
She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, st...
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She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, started shaking and feeling like restlessness. She went to bed and covered up under lots of covers, and just froze. She put on extra clothes, layers of blankets and her legs felt swollen, painful. She kept having to urinate a lot, could not sleep, was awake all night, her arm started hurting as well, could not lay on that side, and then started getting cold/hot flashes. She felt as though her heart was racing, and her brain as well trying to figure out what was happening. Her husband took her temperature in the morning and it was 101.9, which her normal is 97.9. At that point she was exhausted from being up all night, and was frightening and couldn't stop trembling all night long into Saturday. When day broke on Saturday shew as not able to get out of bed for the entire day. She could not eat, had no appetite and drank water day. On Sunday she felt a little better, ate breakfast and the rest of the day went okay other than being exhausted. This morning, 3/22/21, she still feels lofty, is able to function and feels a little removed/foggy feeling. She is still not feeling completely well, but is on her way. Not steady on her feet yet. She took some Bayer aspirin for the symptoms.
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| 74 | 2021-03-23 | loss of personal independence in daily activities |
SEVERE, SEVERE back pain, from lower to upper back. trouble breathing--taking a deep breath. using ...
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SEVERE, SEVERE back pain, from lower to upper back. trouble breathing--taking a deep breath. using Tylenol for pain, but it is barely making a dent in the pain. started Sat. morning, bad on Sun. (3/21); then Mon. and Tues. morning = not so bad. but Tues. night and today, Weds. 3/24, VERY BAD pain in back returned, rendering me dysfunctional.
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| 74 | 2021-03-23 | mental status changes |
Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who present...
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Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who presents with acute onset early this a.m. nausea vomiting and change in mental status. History was obtained from the husband as patient is minimally responsive to verbal stimuli at this time. He states she was in her usual state of health until when she awoke this morning. Yesterday in usual state of health that she did have her 2nd COVID vaccine with the Pfizer variant. He states that day she was in her usual state of health with some mild arm pain on the left where she received the vaccine. This morning she awoke with a headache, fever, chills however was ambulating and conversing appropriately. She had no appreciable focal deficits at that time per the husband. She ate breakfast however she subsequently began vomiting. She progressed to a change in mental status with minimal responsiveness. She would say 1 or 2 words and that was it. They then presented emergency department. Diagnosed with severe sepsis, acute encephalopathy, acute meningitis, liver shock, autoimmune hepatitis, ascending cholangitis, acute pancreatitis.
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| 74 | 2021-03-24 | sleep disorder |
First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, ...
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First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, nausea, extreme tiredness that sleep did not help. Also, hot flashes during night. took Tylenol. Second day, pains were mostly gone, but nausea and a sore arm where the injection was given, and dizziness, and tiredness. But if I would lie down, I couldn't sleep. Later that day my injection site was swollen, redness (about size of an orange) sore to the touch and itched, and was hard. The third day my injection sites pain went further to my left breast, up to my shoulder. It had spread and was now a light pink. A small amount of dizziness.
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| 74 | 2021-03-29 | disorientation |
1. HEADACHES every day that are sharp and variable in location and come and go all day. Getting le...
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1. HEADACHES every day that are sharp and variable in location and come and go all day. Getting less intense with time. Associated symptoms similar to a TIA. On date of injection she felt DISORIENTED. She has been feeling nauseous and and with intermittent chills. All symptoms continuing as of office appt today 3/30/21
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| 74 | 2021-03-29 | feeling abnormal |
1113 Patient reports to Nurse compliant of right arm numbness, intense headache, "feeling funny, fee...
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1113 Patient reports to Nurse compliant of right arm numbness, intense headache, "feeling funny, feels like body is floating." Nurse obtained assistance and vitals: 144/82, HR 74, SpO2 99. 1118 Neuro assessment by Nurse shows sluggish response, diaphoresis, clammy, bilateral extremity response weak. Benadryl 25mg PO given. NO swallowing diffliculty. 1120 This nurse arrives, vitals 178/82. Diaphoresis worsening, neuro decline verbal response unable to identify companion, headache worsening, upper respiratory stridor upon ausculation, pulse increased. 1125 0.3 mg Epi given IM LVL Vitals 192/63, 84, RR22 99% phoned EMS 1127 Ems arrived, report given including medications administered and vitals Patient taken to closest Emergency Center where the following notes were dictated: Chief Complaint Patient presents with ? Dizziness pt brought from urgent care after receiving her second vaccine, reported dyspnea and dizziness at clinic. pt was given 0.3 of epi and 25mg of benadryl prior to arrival. pt arrives in no distress. ? Shortness of Breath Chief complaint: Reaction to Covid vaccine History of chief complaint: This 74-year-old female presents to ER stating that she had her second Covid vaccine this morning in the urgent care when she began to have some lightheadedness shortness of breath and headache. She said she also felt quite cold. The squad was called and the patient had been given subcu epi and Benadryl. She has also a diabetic and her blood sugar was found to be 176 prior to transport.
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| 74 | 2021-03-29 | sleep disorder |
March 19 Herpes simplex outbreak left mos pubis, mild symptoms; diminished by March 21. Followed by...
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March 19 Herpes simplex outbreak left mos pubis, mild symptoms; diminished by March 21. Followed by mild pre-outbreak nerve sensitivity around the waist. Late in the day March 22 brought the onset of sharp right facial pain extending from the chin to ear with sensitivity extending to top of the scalp (right side). Pulses of shooting pain extending from the jaw to ear and temple (right side) kept me awake for most of the night. The pain subsided somewhat over subsequent days. Having had shingles at age 24 I suspected that this was the cause, but also (despite no indication that this was related to a sinus infection) I proceeded with daily salt and betadyne solution sinus rinses just to be cautious. March 23 noted presence of sores inside my mouth, lining the inside jaw below the molars. Over time blisters appeared further back and small sores were present on the roof of my mouth. By March 28 I was tired of the facial and mouth pain, which now was extending to my tonsil and tongue base at the back of my mouth. Sought medical care.
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| 74 | 2021-03-30 | feeling abnormal |
Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to ...
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Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to faint; I got really weak; Felt like I was going to threw up; Light-headed; I did feel like I was going to lose consciousness; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) (Batch/Lot Number: EL9261 and Expiry Date was Unknown) via an unspecified route of administration on 28Jan2021 12:45 at single dose for covid-19 immunization. Medical history included diabetes and asthma. Concomitant medications included empagliflozin (JARDIANCE) and lisinopril. Consumer (Retired Nurse) stated, "I had my COVID Vaccine first dose yesterday 28Jan2021 at 12:45 in the afternoon and I was standing in my kitchen cooking and all of sudden I got really weak and light headed and it was like black darkness was coming over my head. I was afraid, I was going to faint. My stomach was upset. I made up to the bathroom, sat on the toilet, had a bowel movement and felt like I was going to threw up, never did threw up. I got real tired from headache and I just sat there until I thought it was safe to stand, which I did. So, I was reading in my little brochure and it said what to call this number to report any side effect so I was not dizzy but I did feel like I was going to lose consciousness." The patient assessed the events as non-serious with outcome of unknown. Reported causality for COVID Vaccine to events for stomach upset, headache was related.
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| 74 | 2021-03-30 | nervousness |
severe constipation; nervous; sever abdominal discomfort; This is a spontaneous report from a contac...
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severe constipation; nervous; sever abdominal discomfort; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via unspecified route of administration on 30Jan2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included blood pressure and cholesterol. The patient concomitant medication included amlodipine besilate (NORVASC) and simvastatin. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) for COVID-19 immunisation. On an unknown date in Jan2021 the patient experienced severe abdominal discomfort and developed severe constipation on 31Jan2021. The patient felt nervous on an unknown date in Jan2021. The patient wanted to know if the events caused were due to vaccine. The patient took Miralax and a suppository (not specified) as treatment to severe abdominal discomfort and severe constipation. The seriousness of the events was reported as non-serious. The outcome of the event severe constipation was not recovered while for other events was unknown.
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| 74 | 2021-03-31 | disorientation |
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si...
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a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
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| 74 | 2021-04-01 | loss of personal independence in daily activities |
weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated p...
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weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated prior to this admit; shaking; chills; severe headache; right mid and low back pain; high fever up to 103 degrees; Not able to get out of bed except to get to nearby bathroom; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 74-years-old via an unspecified route of administration, administered in arm left on 05Mar2021 15:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included anal cancer (h/o anal cancers/p chemo & RT2013), hypertension, hypothyroidism and new fe deficiency anemia dx during this admit from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has known allergies to Ampicillin, clindamycin, trilafon, imipramine. The patient reported that 4.5 days after 1st dose of Pfizer vaccine on morning of 10Mar2021 09:00, the patient woke up with shaking chills, severe headache, right mid and low back pain, high fever up to 103 degrees within 1/2 hr of onset and not able to get out of bed except to get to nearby bathroom to use toilet when needed. The patient took Tylenol 500 mg up to 5 doses by 10:00 am of 11Mar2021 when fever would not abate; the patient was weak and lightheaded on an unspecified date and since lived alone called a number to take her to ER. On an unspecified date, her blood pressure was low 80's to 90's over 40's to 50's all thru night and 1000 more mg of Tylenol was given at 4:00 am and fever then lowered to 99 or 100. Full infectious work up negative for bacterial sources including abdominal and pelvic cat scan, abdominal ultrasound, CXR, urine culture, she received 2 1/2 liters of IV fluid and IV Ceftriaxone and Flagyl in ER. In case bacterial cause which was not found including blood cultures, due to her BP still not improved by 5:00 am as she was dehydrated prior to this admit, she was admitted on medicine floor for 2 days. The patient underwent lab tests and procedures which included abdomen scan: unknown result on an unspecified date, blood pressure measurement: low 80's to 90's over 40's to 50's all thru night on an unspecified date; still not improved on an unspecified date, body temperature: high fever up to 103 degrees on 10Mar2021; 99 or 100 on an unspecified date, chest x-ray: unknown result on an unspecified date, culture urine: unknown result on an unspecified date, sars-cov-2 test: negative on 10Mar2021, ultrasound abdomen: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included IV, fluids, 1 dose of 2 different IV antibiotics (Ceftriaxone and Flagyl) and Tylenol. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-04-01 | memory impairment |
Auto Accident - syncope - Ambulanced to Hospital. Passed out and hit a tree, totaled vehicle with n...
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Auto Accident - syncope - Ambulanced to Hospital. Passed out and hit a tree, totaled vehicle with no memory of the event. CT without contrast, blood work, EKG, fluid given IV. Stayed about 3 hours and was released.
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| 74 | 2021-04-07 | feeling abnormal |
Immediately felt nausea; my head felt enlarged. Dizzy. Next day dizzy feels like the flu-sore muscl...
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Immediately felt nausea; my head felt enlarged. Dizzy. Next day dizzy feels like the flu-sore muscles in legs/body/nauseous/cant sit up- need to lay down. Feel very uncomfortable.
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| 74 | 2021-04-09 | excessive sleepiness |
Initial soreness at injection site at upper right arm + and right shoulder. 3 hours later I had wea...
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Initial soreness at injection site at upper right arm + and right shoulder. 3 hours later I had weakness in right arm. Next morning (13 hrs later) Aches and pains thru entire body. All joints and muscle fatigue. Difficulty in moving joints. Difficulty walking and used a walker. Bedridden for 3 days. Slept most of the days and nights. Could walk around on day 4 still having substantial pain. Very tired. Today is day 22 since my Covid 2 inoculation and I still have latent tiredness and legs aches and pains which prevent me from walking more than 100 feet without using assistance from a walker.
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| 74 | 2021-04-12 | amnesia | Hands, Arms, would not work. WAlking with help. Lack of memory for several hours |
| 74 | 2021-04-15 | confusional state, anxiety |
started to itch; Scratchy throat; Mental confusion; tightness in throat; Her throat tightening made ...
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started to itch; Scratchy throat; Mental confusion; tightness in throat; Her throat tightening made her anxious and her respiratory status worse; Her throat tightening made her anxious and her respiratory status worse; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), via an unspecified route of administration, at the age of 74 years, administered on the left arm on 08Feb2021 12:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypersensitivity. Additional Information for Other Conditions: medications, cloves, spices, MSG, processed foods and she can't take any antibiotics. There were no concomitant medications. The patient wanted to report a less severe reaction she experienced within 10 minutes of the first dose 08Feb2021. After her vaccine within 10 minutes, she started to itch. The patient had a scratchy throat, mental confusion, tightness in her throat. The tightness in her throat she usually experiences with clove, food allergies and antibiotics. She was familiar with what was happening. The side effects did go away. They asked her to stay 30 minutes. As soon as she left, she took one Benadryl and 10 min later she took a second one. Then, it subsided. Her itching did go into the next day. Her throat tightening made her anxious and her respiratory status worse. It happened so quick. Her first concern was conflicting facts sheets in regards to taking the second dose. The patient wanted to know what was recommended. Should she take the second dose. She has never had anaphylaxis so she doesn't have an Epipen. She can take Benadryl which has gotten her out of more severe responses before. Therapeutic measures (Benadryl) were taken as a result of the events. The outcome of the event itch was recovered on 09Feb2021 while other events were recovered on 08Feb2021.
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| 74 | 2021-04-15 | loss of personal independence in daily activities |
I can't bend my arm as far as I use to be able to I can't flex it toward my shoulders/stiff and sore...
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I can't bend my arm as far as I use to be able to I can't flex it toward my shoulders/stiff and sore arm; soreness in the arm / she gets a little pain going into one of her fingers sometimes / sometimes the pain goes into her hand/throbbing going into her hand; The arm used to be able to, without hesitation, reach behind her head to brush her hair or reach to fix her necklaces those things she couldn't do; she was lethargic, she didn't feel like doing anything, so she guesses she would say tiredness; She has pain if she tries to force it / when I first got it I did experience localized pain; feels like her arm is swollen with some tightness; feels like her arm is swollen with some tightness; getting a gallon of milk out of the refrigerator I almost dropped it/Fixing my hair I can't reach back behind my head very easily/ reach behind her head to brush her hair or reach to fix ~; sometimes the pain goes into her hand/throbbing going into her hand; she was lethargic, she didn't feel like doing anything, so she guesses she would say tiredness; shivering / Chills; she feels discomfort in her forearm and not as much in the upper arm; sore muscles in the arm where it was given; still has pain on the injection site/localized pain; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, in left arm on 27Jan2021 (Batch/Lot Number: EL9263) as single dose for covid-19 immunisation. Medical history included patient was diagnosed with glaucoma about a year or a little over a year, prediabetes, cholesterol and blood pressure. Concomitant medication(s) included simvastatin (SIMVASTATIN) 40 mg once daily taken for cholesterol, lisinopril (LISINOPRIL) 20 mg once daily by mouth taken for blood pressure; metformin (METFORMIN) 30 mg once daily taken for diabetes; timolol (TIMOLOL) taken for diabetes, dorzolamide hydrochloride (DORZOLOMIDE HYDROCHLORIDE) taken for glaucoma. After vaccination from that day until now (11Feb2021), patient still has pain on the injection site. She wanted to know if that is usual. She is concerned because she had heard that the AEs from the second dose are worse than from the first dose. Patient family doctor didn't want to entertain her concern. Her doctor said that she should refer to the one who gave the vaccine which is from the County in (State). Patient couldn't believe her doctor wouldn't want to take care of me since he said my AE is related to the vaccine. This was the weirdest thing she had from her doctor.Patient called and stated that she was am a person who received the Pfizer vaccine 16 days ago and she was experiencing still sore muscles in the arm where it was given she could not bend my arm as far as she use to be able to she cannot flex it toward her shoulders and its she just talked to her doctor's office where she told them sahe was having some adverse effects from the shot. Patient was calling to see if got any same reports of peoples whose arms got stiff, muscles are stiff, can't flex, sore, even like she say she was now 16 days after the injection she think that's a little bit long to still be feeling something. Patient also mentioned she was beginning to wonder if she going to get rid of this soreness in her arm or is that something permanent. Patient explained further when she first got it she did experience localized pain, I did not experience fever, did experience though shivering or chills but kind of thought that was because it was chilly but it might have been from the vaccine now that she think about it but she was not sure mostly it was the soreness in my arm that's her main concern is this lingering soreness in the arm after 16 days she had the injection on the 27Jan. At end of call mentioned she had seen the general side effects and may have experienced a few more other than this one but this is the one that's still with her not being able to utilize my left arm like she was used to be able to do even just reaching up to a cabinet for something in a higher cabinet or something she can't do that without feeling she was going to drop what she was reaching for and its sore its sore to do it. Reaching for a skillet down below in a lower cabinet it's like no it's not going to work or getting a gallon of milk out of the refrigerator I almost dropped it. So she feel like what was going on here I should be over this by now she can't, with both arm she use to be able to bend at the elbow and touch my shoulder well she cannot still can with my right arm but with the left arm she can't do that. She like 2 inches from being able to touch my shoulder. Fixing her hair she can't reach back behind my head very easily its with pain and effort to brush and she was left handed so maybe I shouldn't have gotten it in my left arm here I am 16 days later and she still feel like I can't utilize my arm like she use to be able to not totally disabled but know its disability in it and its annoying the pain was annoying even taking Ibuprofen.Patient really didn't have much effects, a little bit of chills but they were having cold weather, she was from (State) so she might get a chill if she opens up the windows. She really had no significant adverse effects at first except soreness in the arm, she says of the things recanted on the internet, she didn't have fever, she may have had some chills but she was lethargic, she didn't feel like doing anything, so she guesses she would say tiredness for the first day or so but what bothers her is that was 27Jan and she still does not have full use of the arm in movement. The arm used to be able to, without hesitation, reach behind her head to brush her hair or reach to fix her necklaces those things she couldn't do and she would say oh goodness what is going on. She has pain if she tries to force it and she thought well she will exercise to limber it up. She is not having continual pain like if she leaves her arm down comfortably but trying to do activity like reaching up to her shoulder or her neck or behind her head. She couldn't do that she would say the last few days it has been a little bit better but there is still pain there. Her vaccine card is in her purse she is going to be going go to the appointment in a couple of days and it scares her because she don't want to have her arm on the other side hurt, if she gets she was going to ask them to put it on the other side but she doesn't want to go through this again and what if it is permanent and both arms are then disabled she would rather have one of them working than both of them. Prior to the injection, her arm had no problem. She states she cannot touch her shoulder anymore and is unable to reach behind her neck to latch a necklace. She states now, she feels discomfort in her forearm and not as much in the upper arm. She states sometimes the pain goes into her hand; she states while she is quietly watching tv, she notices some throbbing going into her hand. She's not affected by arthritis and things like that and she's had pretty good health. She has gotten the flu and pneumonia shot and any other injections with no problem. She had a comfortable initial stick when she received the COVID vaccine with no particular pain at the time of injection. She stated she did not want to do anything for 2 days and was really tired with a stiff and sore arm. She called the doctor after 2 weeks and was not able to get ahold of a doctor. Caller is wondering if there have been reports of duration of this side effect for this long and whether or not she should receive the second shot. The outcome of the events not resolved for injection site pain and myalgia and unknown for rest of the events. Follow-up (11Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported new events were added information. Follow-up (22Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported patient information, concomitant information dosing details and indication, historical condition and new events. Follow-up (22Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported: new events arm discomfort and swollen arm.
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| 74 | 2021-04-22 | loss of personal independence in daily activities |
vaccine #1 received 3/2/2021 and starting on 3/9/2021 symptoms of right fingers/hand/wrists swelling...
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vaccine #1 received 3/2/2021 and starting on 3/9/2021 symptoms of right fingers/hand/wrists swelling, pain, burning, tingling and pins/needles. Pain 8/10. Consulted with Orthopaedics thinking trigger finger or carpal tunnel, Prednisone prescribed and EMG ordered. EMG conducted 3/23/2021 vaccine #2 received 3/22/2021 Same symptoms and pain level to left fingers/hand/wrist started on 4/15/2021 Visit with PCP 3/29/2021 and was made aware of reactions but knew she was under care of Ortho She has been in excruciating pain, debilitating and crippling at times. Difficulty to perform daily activities.
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| 74 | 2021-04-23 | excessive sleepiness |
very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable c...
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very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable consumer. A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 13:30 (at the age of 74-years) as SINGLE DOSE in Arm Left for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Lung cancer (lobectomy), copd, emphysema. The patient previously took Pcn (penicillin), codeine, morphine, Indocin and had drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced very tired, sleeping alot, dizzy spells and diarrhea. The patient did not receive any treatment. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was not recovered.
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| 74 | 2021-04-24 | abnormal behaviour, disorientation |
TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where...
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TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where she was, she didn't feel like herself; since this happened she makes mistakes; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the upper right arm on 06Mar2021 at 17:30 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus diagnosed in 1998-1999, high blood pressure diagnosed about 3 years later from Diabetes Type 2, like 2002 and little bit obesity. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. The patient's concomitant medications were not reported. The patient was not administered additional vaccine on same date as suspect vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. On 19Mar2021, the patient woke up so disoriented, she didn't know where she was, she didn't feel like herself, felt weird. She was staring out the window, and she daughter called her on the phone and caller told daughter she was feeling crazy, that morning was feeling weird and her daughter informed it was not morning it was in the evening and patient did not sound right. The patient's face from the nose down, looked like her teeth were melting, both cheeks looked like they were melting. She said her bottom lip was turned out and down, sagging, drooping. On 19Mar2021, about 18:30, the patient went to emergency room and was admitted to the hospital on 19Mar2021 around 21:00-22:00. On 19Mar2021 around 21:00-11:00, while she was in the hospital, her sugar had gone up to 310, hard time bringing her sugar down and blood pressure was way up, way higher than normal. In the hospital the patient was told she had transient ischaemic attack (TIA). The patient was discharged on 21Mar2021. The patient informed that since it happened she was making mistakes. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EP6955) via an unspecified route of administration in the upper right arm on 27Mar2021 as single dose for COVID-19 immunization. The informed that the she waited until after she received her second dose to inform about the events just in case something else happened. She stated she was fine now, everything was ok and stated she did believe the events were related to the vaccine. The patient followed up with her primary doctor, talked to him about her experience and going into the hospital. He instructed her to call Pfizer and let them know of her experiences. The patient underwent lab tests and procedures which included Computerised tomogram scan, Magnetic resonance imaging on unspecified date in Mar2021 and sugar 310 and hard to bring down, blood pressure was way up on 19Mar2021. The outcome of event since it happened she made mistake was unknown and rest all events was recovered on an unspecified date 2021.
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| 74 | 2021-04-25 | feeling abnormal |
She had diareah and nausea for a few days with 1st shot but it got better. She complained about "fee...
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She had diareah and nausea for a few days with 1st shot but it got better. She complained about "feeling off" after the 2nd shot. Went to bed to try to sleep it off and she never got up again. We think she died Wednesday night or Thursday morning by how she stopped responding to texts. She was found deceased on Friday. They won't do an autopsy here. funeral home has her for now.
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| 74 | 2021-04-26 | depressed mood, feeling abnormal |
The day after the second Pfizer shot, I felt worse and worse as the day progressed with the symptoms...
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The day after the second Pfizer shot, I felt worse and worse as the day progressed with the symptoms we were warned were possible: feeling awful with no appetite; temperature 100.8 (normal for me is around 96.3); injection site red and hot. They gradually eased up the third day with temperature down to 98.4. I felt wiped out for the next few days even after my temperature was completely back to normal. However, I also experienced other symptoms. Starting on the third day, I experienced headache, neckache, and a more painful lower back and left hip than I've felt in decades – to the point that I could barely walk. I had been in a bicycle accident when I was 14, resulting in a concussion, a cracked lumber vertebra, and damage to my coccyx so severe that it was removed two years later. I've had a weak left hip ever since. However, since that accident, I've had regular chiropractic treatment, and, in the last 20 years, clinical massage treatments. As a result, my spine has stayed healthy and I've led a normal, active life. It was therefore a complete shock when those old symptoms returned after the Pfizer second shot. Although they've improved with chiropractic and massage treatments, after 6 weeks I'm still not able to walk very far due to the pain. Feeling quite depressed, I talked with my chiropractor yesterday and found out that some of his patients have also experienced the onset of long ago familiar symptoms at sites of old injuries. He suggested that I file a report with the CDC in case these symptoms are not just coincidental.
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| 74 | 2021-04-27 | amnesia |
She had her 2nd shot on Thursday, April 22, 2021and 830 Saturday, April 24 2021 she was found on her...
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She had her 2nd shot on Thursday, April 22, 2021and 830 Saturday, April 24 2021 she was found on her floor unconscious by a neighbor who had not seen her since Friday morning (April 23). She has had several tests while in the hospital (she was admitted April 24, 2021) and cannot walk or remember what happened, yet all of her tests show no abnormalities.
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| 74 | 2021-04-27 | disturbance in attention, impaired work ability |
couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; couldn't con...
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couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; labored breathing / Breathing difficult; swelling face; swelling face, mouth, tongue/my skull was swelling; swelling face, mouth, tongue/my skull was swelling; swelling face, mouth, tongue/my skull was swelling; Dizzy; weak; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot ER8727, second dose) solution for injection intramuscular in the left arm on 22Mar2021 at 09:00 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: sulfa drugs. There were no concomitant medications. Historical vaccine included BNT162B2 (first dose, lot EN6198) for COVID-19 vaccination on 01Mar2021 and experienced nausea, dizzy, weak, feeling unwell, and sore arm at injection site. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Mar2021 at 09:30, the patient experienced labored breathing, swelling face, mouth, tongue/my skull was swelling, out of breath with little exertion, dizzy, and weak. On 23Mar2021, the patient couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed. The events resulted in emergency room/department or urgent care. Treatment for the events included EPIPEN, steroids, ZYRTEC, famotidine. The outcome of the events was recovering. The patient was not test for COVID post vaccination.
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| 74 | 2021-04-27 | memory impairment |
Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of so...
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Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of sorts; Arm was sore; This is a spontaneous report from a contactable other hcp (nurse). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 18Jan2021 at 09:00 (Lot Number: EL3247, Expiration Date: Apr2021) as single dose for COVID-19 immunization. The patient's medical history included spinal fusion surgery from 2019 to an unknown date. The patient previously received 1st Shingrix injection and experienced her arm turned really red and swelled up (so her doctor told her not to take the 2nd injection). There were no concomitant medications. On 19Jan2021, the patient experienced arm was sore. On 21Jan2021, the patient felt out of sorts. On 22Jan2021, the patient experienced muscle aches and pains. She is not sure if the muscle aches are due to her just getting old or from the vaccine. The muscle aches are especially in her legs. On an unspecified date, the patient experienced aching legs, gradually getting worse and her memory is affected. She is gradually getting worse, but doesn't know if it's the weather, or is it a possibility that it's the vaccine. The patient's memory is affected, then clarified that it has nothing to do with the vaccine, she is just getting old. She asked if people have reported muscle aches and pains for weeks after. She is due to have the second injection on 08Feb2021. No family medical history relevant to events. The events did not result in emergency room visit or physician office visit. The outcome of the muscle aches and pains was not recovered and was unknown for the rest of the events. Follow-up attempts are completed. No further information is expected.
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| 74 | 2021-05-04 | confusional state |
On 5/5/21 at 1030 the patient developed right-sided facial droop, and right arm and leg weakness. Sh...
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On 5/5/21 at 1030 the patient developed right-sided facial droop, and right arm and leg weakness. She had accompanying headache and confusion (unable to state age or year of birth). Patient had normal glucose and BP 146/72. Neurological impairment was 5. Patient received alteplase for stroke. The patient also received ondansetron pre-hospital per EMS. Patient received Norco and fluids. Patient will be admitted to the ICU for monitoring post-alteplase.
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| 74 | 2021-05-04 | confusional state |
At 1030on 5/5/21 the patient developed right-sided facial droop, and right arm and leg weakness. The...
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At 1030on 5/5/21 the patient developed right-sided facial droop, and right arm and leg weakness. These were accompanied by headache and confusion (unable to state year of birth/age). No intracranial bleed was noted on head CT and NIHSS was 5. Glucose WNL and BP 146/72. Patient received alteplase to treat suspected ischemic stroke. Patient received ondansetron pre-hospital for nausea, and received Norco and a fluid bolus. Patient is being admitted to ICU for monitoring after alteplase administration.
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| 74 | 2021-05-12 | mental status changes | Admitted for altered mental status and dyspnea. NSTEMI, elevated trops., COPD exacerbation |
| 74 | 2021-05-13 | feeling abnormal |
During the last week of February the patient states she was feeling off and having intermittent epis...
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During the last week of February the patient states she was feeling off and having intermittent episodes of dizziness. On the day of admission she had an episode of wording finding difficulty that lasted for approximately 15 minutes. By the time she presented to the ED her symptoms had resolved. Patient had been diagnosed with DVT and PE in October 2020. She had been warfarin for many years for history of DVT. Her INRs had recently been fluctuating considerably and so she was changed to Eliquis. A few weeks before her admission there was concern that her that the Eliquis wasn't working because a lower extremity ultrasound showed persistent DVT so she was converted to Lovenox.. Patient was admitted to the hospital. After her work-up she was discharged with a diagnosis of TIA. Cardiologist requested that event be submitted to VAERS.
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| 74 | 2021-05-19 | memory impairment |
Patient made appointment, came in, answered all questions on VAR form as her first dose. No records ...
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Patient made appointment, came in, answered all questions on VAR form as her first dose. No records in our systems of any previous vaccine and verbally verified with patient prior to giving vaccine. We were notified by a family member after the fact that the patient had already received her Pfizer series earlier in the year and that patient is forgetful. Family reported three days post vaccine that patient was hospitalized
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| 74 | 2021-05-24 | disorientation, mental status changes |
3/20, admitted day after covid vaccine with AMS. Patient presented to ED with HA and confusion. Afte...
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3/20, admitted day after covid vaccine with AMS. Patient presented to ED with HA and confusion. After speaking with family it turns out patient with history of dementia. Symptomatic treatment and IV fluids given with good improvement in symptoms. On recheck the disorientation and altered mentation seem to have greatly improved. The CT scan of the head shows no tumor or bleed but does have nonspecific abnormalities. There is atherosclerosis. Severity of symptoms are concerning as they are completely unexplained with no trauma no signs of infection no other new exposure or carbon monoxide toxicity. Patient admitted. No focal neuro deficits-ordered mri brain however cancelled given history of dementia. Patient did have elevated ESR that was elevated, she had HA (not c/w TA). Patient is stable, appropriate for discharge to home the morning of 3/21/2021.
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| 74 | 2021-05-28 | feeling abnormal |
Extreme vertigo-numbness in face-paralized in arms and legs-nausea-sensitive to light -could not wal...
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Extreme vertigo-numbness in face-paralized in arms and legs-nausea-sensitive to light -could not walk-brain fog MRI of brain without contrast-xray of chest - CT scan Vertigo has not gone away-nausea has not gone away Currently on antivert (meclizine)
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| 74 | 2021-05-28 | insomnia |
I have constant pain at the injection site. Comes & goes. The person might have given it to me too h...
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I have constant pain at the injection site. Comes & goes. The person might have given it to me too high on the shoulder . The pain becomes evident when I move the arm up to my shoulder. It's now May 29. It is the same pain as the time of the injection. The night of the injection I had terrible arm pain. I was unable to sleep the entire night. Could not lie on that shoulder. Hope this is not nerve damage.
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| 74 | 2021-05-30 | loss of personal independence in daily activities |
"Admit Date: 5/14/2021 Discharge Date: 5/15/2021 The patient is a 74 y.o. female, history of...
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"Admit Date: 5/14/2021 Discharge Date: 5/15/2021 The patient is a 74 y.o. female, history of MS, history of cerebellar ataxia and gait instability at baseline who presents for evaluation of lower extremity weakness. Patient received her second Covid vaccine yesterday. Patient reports baseline right lower extremity weakness with foot drop. She reports she awoke today and has had bilateral lower extremity weakness. Patient reports she normally walks with a cane but has been unable to stand up and get out of her chair. She typically uses a cane for ambulation but states she has been unable to complete her ADLs secondary to immobility. She reports mild headache throughout the course of the day but no thunderclap quality or maximal headache at onset. No neck pain. No chest pain or shortness of breath. She reports otherwise, ""feeling achy."" No fevers. No chills. At discharge: #left lower extremity weakness: resolved overnight. MRI brain and L spine without acute MS flare, no signs of acute stroke or cord impingement. ? Reaction to Pfizer vaccination. Now returned to baseline. Cleared by PT for return home. #Multiple sclerosis: chronic right upper and lower extremity weakness. Unchanged. No active MS lesions no MRI brain/L spine as above. Recommended routine follow up with her neurologist. No changes to medications at this time #Hyponatremia: very mild, resolved on day of discharge #Hypothyroid: continue synthroid"
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| 74 | 2021-05-31 | sleep disorder |
Severe nerve pain began on 4/17/21 on middle of back on left side of spine. Went to urgent care 4/21...
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Severe nerve pain began on 4/17/21 on middle of back on left side of spine. Went to urgent care 4/21/21 and received one shot of Torodol for about 8 hours of pain relief. The next day 4/22/21 a blister appeared in front left side of breast bone. Urgent care PA diagnosed it as Shingles and gave a second Torodol injection that did not relieve the pain. Ibuprofen was recommended and to see regular doctor ASAP. Saw Dr. 6 days later on 4/28/21 where she prescribed Gabapentin. That helped with the pain and enabled sleep. As of this writing, 6/1/21 there is still some residual pain in the same area.
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| 74 | 2021-06-02 | feeling abnormal |
Post a second shot of Pfizer Vaccine, normal symptoms appeared of tiredness, sore arm, and generally...
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Post a second shot of Pfizer Vaccine, normal symptoms appeared of tiredness, sore arm, and generally feeling awful started. Went to see a heart doctor as well, thinking something may be wrong, kept getting worse. Persistent pain in the breast and under armpit/shoulder area started to get severe. Had trouble breathing. Eventually ended up at Urgent Care on May 26th - presented with Fluid in Lungs. Went to the hospital via ambulance, where liver enzymes and liver ducts also inflamed. No pneumonia, no positive for COVID, not positive for hepatitis or any other bacteria-related infections. all liver enzymes have returned to normal levels, but one. Still have fluid in the lungs, though it it getting better on its own and we are now back at home.
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| 74 | 2021-06-09 | anxiety | My pulse was aridic and having anxiety. I was in the hospital for four days, and bp was up. |
| 75 | 2021-01-07 | impaired work ability | Dizziness, causing 2 days missed work, lasting 4 days |
| 75 | 2021-01-11 | memory impairment |
At 11:40am on 1/8/21, resident appeared catatonic and was just staring at the wall. When on unit, o...
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At 11:40am on 1/8/21, resident appeared catatonic and was just staring at the wall. When on unit, observed resident seated in a chair, blankly staring at the wall with no loss of consciousness. Blank stare accompanied with mild jerky movement. Resident was safely assisted to bed. Oxygen at 3lpm was administered. Petit mal- like seizure lasted for 5 minutes. Resident regained prior level of alertness and doesn't recall what had happened. Resident with no known history of seizure disorder.
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| 75 | 2021-01-14 | feeling abnormal |
feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous repor...
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feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Covid 19 vaccine on 07Jan2021 then the day after (08Jan2021), she began feeling fatigue, "just not herself, out of whack in her body", and diarrhea. The patient reported that she was fine now. She inquired if those were normal. The outcome of the events was recovered on Jan2021. Information on the lot/batch number has been requested.
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| 75 | 2021-01-18 | feeling abnormal |
odd feeling; dizziness; This is a spontaneous report from a contactable nurse (patient herself). A ...
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odd feeling; dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FL3246, expiration date unknown), intramuscularly in left arm (also reported as subcutaneously in the left deltoid muscle) on 07Jan2021 at 10:00 at a single dose for COVID-19 immunisation. Medical history included osteoarthritis and depression on unknown dates and other unspecified conditions diagnosed in 2012 or 2014 and also needed glasses. Concomitant medication included bupropion as antidepressant for about six years. Family medical history was reported none. The patient experienced dizziness on 07Jan2021 following the first dose. The patient received the first dose on 07Jan2021 (yesterday) morning. She did not have any symptoms after the injection, but by the end of the afternoon/ late afternoon or early evening, she started feeling dizzy. She was not sure if it was because of her age. In the morning of 08Jan2021, when she woke up, she was feeling more dizzy. It was not to the point where she felt she was going to fall though. She would like to know if this has been reported as a common side effect. The patient asked when will it get better and if this will affect her second dose in 3 weeks. There was no prescriber and patient went to designated vaccine site which was not a military facility. The patient further reported that the dizziness was nothing notable last night. It was not better. In the morning of 08Jan2021, she walked around a bit and ate breakfast, thinking that would take away. When sitting, she as fine. When getting up to walk, she noticed it. The room was not spinning. It was just an odd feeling. When reading the vaccine card, she said she is looking for glasses and confirmed that she needed them prior to getting the vaccine. The patient also informed that one of the side effects of bupropion was dizziness and she did not take it on 08Jan2021. She did take the dose in the night of 07Jan2021. It was in a pharmacy vial with no lot or expiration. The patient had no previous history of previous immunizations with Pfizer vaccine. There were no additional vaccines administered on same date as the BNT162B2. The event did not require ER or physician's office. There were no prior vaccinations within 4 weeks. The event was considered non-serious by the reporter. There were no relevant tests. The outcome of the event was not recovered.
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| 75 | 2021-01-18 | excessive sleepiness |
Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So ...
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Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So to ER for fluids. Don?t know how to go back. Original start of the event date was 01/14/2021. In am
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| 75 | 2021-01-18 | excessive sleepiness |
injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling un...
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injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling unwell and wanting to sleep all day
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| 75 | 2021-01-19 | anxiety |
Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbea...
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Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbeat and because of her previous history of reaction to chemicals she became anxious. Pt further evaluated by NP and pt c/o itching to back of throat. No SOB. At time of NP evaluation heart rate within normal limit, 84. Alert and oriented. No acute distress. Pt very anxious. Pt monitored for one hour with no issues or emergent care needed.
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| 75 | 2021-01-21 | abnormal dreams, sleep disorder |
Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe B...
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Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe BP, but never had that happen before. I was anxious as I have anxiety disorder! But my face was RED and TIRED looking. I asked staff what wrong. No swelling at that time! 4:40 PM. That nite, my heart started POUNDING HARD all night, not stop. Ativan not help. I slept, weird dreams, wake up and still heart pounding. 8 am --- got up and hands, arms, extremities SWOLLEN!! Heart still pounding, Felt like allergic to MSG or nitrates or preservatives or too much salt. Felt weird.. Not faint-- just weird. Tired from the pounding heart. Not fatigued. I did have sore arm, but it was NOT an issue. My hands, toes were red.
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| 75 | 2021-01-24 | sleep disorder |
I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left...
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I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left arm, I couldn't sleep on my left arm due to this soreness. This started the day the soreness started. The following day and up till now I felt very tired and like I needed to take a nap. Due to work I have not been able to nap. On Sunday I noticed I had a fever blister on the right side of face, under my lip by my chin. It looked like a herpes blister. I rarely get them unless there is a serious stressor to my body or if my body is emotionally stressed. Valacyclozir I took 4 of those in the morning and 4 tablets in the evening after noticing them. I put a cream on the blister. On Tuesday or Wednesday 3 or 4 days after the vaccine I felt a pain in my gum by back two teeth, the gums were very painful when I brushed my teeth or put my tongue on it. I went to the dentist Friday the 22nd, however the dentist said it was intraoral herpes that he believes it is looked to the vaccine. Dr. believes the COVID vaccine activated the dormant herpes in my system . He said says it is located over the Greater Palatine Foramen. The herpes on my chin went away. I still feel light sensitivity and fatigued. Dr recommended to see my dermatologist. Either the 22nd or 23rd I had a virutal appointment with my dermatologist. She recommended I take 4 Valacyclozir in the AM and PM. And then 1 day for 10 days. Both doctors recommended not getting the 2nd dose until the herpes vaccine goes away. Once it goes away they suggested taking the Valacyclozir before taking the 2nd dose. I am still not feeling normal. My dentist said he was going to consult a group of dentists to see if any other dentists have seen the correlation between the COVID vaccine and activating the herpes virus. I plan to consult my PCP about if I should delay the 2nd dose.
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| 75 | 2021-01-26 | excessive sleepiness |
On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated...
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On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated, and said she couldn't sit up. She called her husband to come and pick her up. She was afebrile. Blood sugar was 86. She said she just wanted to sleep. She sleep most of the day and through the night until 3:30 am today. She woke up and said she feels fine. She said at one point her body felt frozen and she couldn't move at all.
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| 75 | 2021-01-27 | feeling abnormal |
Dizziness; history included compromised immune status; history included compromised immune status; g...
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Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.
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| 75 | 2021-01-28 | feeling abnormal |
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil...
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Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
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| 75 | 2021-02-01 | feeling abnormal |
Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and ...
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Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and focus) , GI Increase in bowel movements, general malaise. These symptoms have lasted 6 days so far at varying intensity The lung tightness occurred on day 1 and day 4. The nausea has been persistent. The headache was on day 1 and 3. Foggy brain on day 2 and 5. Fatigue everyday. I am concerned about getting the second shot
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| 75 | 2021-02-04 | feeling abnormal |
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes...
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severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
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| 75 | 2021-02-04 | sleep disorder |
Severe shoulder pain. Unable to sleep. Developed over the course of the afternoon and it was 9/10 ...
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Severe shoulder pain. Unable to sleep. Developed over the course of the afternoon and it was 9/10 in severity by evening/bedtime.
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| 75 | 2021-02-05 | disorientation, sleep disorder |
I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burni...
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I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burning up and perspiration was dripping down my body, i felt like i might throw up and that was the last though until I came to on the floor of our walk in shower. It took me a while to orient myself and get up and sat down again on toilet still with pain in head and disoriented. next thing i know i am coming to wedged between the toilet tank and the vanity. I managed to get back on the toilet and sat there wondering what was happening to me. I could tell i was getting better so i just sat there a while longer until i though my legs would hold me so i could get back to the bed. I laid in bed the rest of the night unable to sleep with headache and shivering with being cold even under my blankets. I stayed in bed Saturday then called the doctor first thing Monday morning. I got in to see her at 10:30 Monday morning. She ordered a full blood panel and urinalysis and heart monitor for 48 hours. The blood panel and urinalysis reports are all ok. Have not received report yet from the heart monitor. Doc said I cannot take the second shot.
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| 75 | 2021-02-07 | sleep disorder |
accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; ...
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accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.
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| 75 | 2021-02-09 | sleep disorder |
Shot was painful. I told the assistant I had never had a shot that hurt that badly. She didn't ev...
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Shot was painful. I told the assistant I had never had a shot that hurt that badly. She didn't even acknowledge. After waiting 15 minutes I left with some discomfort but figured my arm will probably be sore for a few days. A couple hours after getting the injection, I couldn't move my left arm without excruciating pain. I'm only assuming she gave me the shot to close to the shoulder joint. It's now Tuesday, February 10, and it is improving with more mobility and not as painful. But, still hurts. Cannot sleep on my left side. I'm concerned about getting the second dosage on February 27 and if this has caused any damage to the joint. So far, I have not seen this side affect listed in any Covid fact sheets.
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| 75 | 2021-02-10 | feeling abnormal |
terrible aches all over; headache; there is something wrong with her smell/she can smell but things ...
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terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.
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| 75 | 2021-02-10 | insomnia | Severe chills, temperature 101, severe headaches, thirst, weakness, body aches , insomnia |
| 75 | 2021-02-10 | poor quality sleep |
tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not i...
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tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-02-10 | sleep disorder |
Patient stated she started experiencing vertigo after receiving the vaccine that was so intense that...
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Patient stated she started experiencing vertigo after receiving the vaccine that was so intense that it woke her from sleep. She stated she required hospitalization for several days.
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| 75 | 2021-02-11 | feeling abnormal |
Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next...
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Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next day had class collapsed and stubbed toe, bleeding etc. ambulance came and assessed, PT felt so weak could not stand but was declared ok to drive by emt, got home and collapsed on the floor and crawled around for 6 days, lived on boiled eggs and rice cakes, doctor said call an ambulance, ambulance picked her up and took her to hospital, hospital took care of her for 16 days, got discharged yesterday (2-9-2021)
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| 75 | 2021-02-11 | insomnia |
Beginning 4 days after shot and running for 8 days, had significant abdominal aches, pains in hip, p...
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Beginning 4 days after shot and running for 8 days, had significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, e.g. standing straight, bending, getting into bed, moving around in bed. Pain moved around - intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Normally active, flexible, healthy, mentally alert, more like a 50 year old. Weight appropriate for height. Eat well and pay attention to staying healthy. Don't like taking medication, so only took one tylenol when temp got to 100.8.
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| 75 | 2021-02-12 | nightmare, insomnia |
Rapid heart beat- on -going continuing up to now- Feb. 13. Varies- Mostly at night- during night. H...
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Rapid heart beat- on -going continuing up to now- Feb. 13. Varies- Mostly at night- during night. Higher blood pressure than normal. Diarrhea- frequent need to go. Gas. Nightmares. Trouble sleeping. Called doctor- did not go in. Took extra ativan and blood pressure meds. Will see doctor next week
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| 75 | 2021-02-13 | anxiety, feeling abnormal |
Approximately 5 minutes post-vaccination for the first dose of the Pfizer vaccine, patient reported ...
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Approximately 5 minutes post-vaccination for the first dose of the Pfizer vaccine, patient reported the following symptoms: being lightheaded, spacy feeling, nausea, and apprehension. EMS, onsite, was immediately called for further evaluation. The following vitals were obtained : 1420: BP - 140/86, Pulse 78, O2 state 98% Patient was moved into cot recovery room from 14 35 to 14 47. After this time, patient felt much better and returned to regular observation room. Patient was picked up by friend to take to house, declined transport to emergency room.
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| 75 | 2021-02-13 | sleep disorder |
1:30AM on 2/12/21 awoke with headache and severe chills. Could not get warm with multiple blankets....
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1:30AM on 2/12/21 awoke with headache and severe chills. Could not get warm with multiple blankets. Temperature rose to 102 degrees by 6AM. Could not sleep as body aches and shivering were intense. Took tylenol at6AM. Temperature started to decline and was only 100 degrees after 3 hours. Temperature rose again to 101 degrees as tylenol wore off. Took tylenol again at around noon. Shivering had abated. still headache and body aches. Was able to sleep but temperature remained elevated into the night. By 2/13/21 temp low grade, body aches, tired. Arm very sore throughout. Started to feel somewhat normal by 2/14/21 but still exhausted and having body aches and a very sore arm.
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| 75 | 2021-02-14 | feeling abnormal |
sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just k...
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sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient). This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
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| 75 | 2021-02-15 | sleep disorder |
Stiff neck & pain across shoulders. Couldn't move them at all & couldn't even turn over in bed, so ...
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Stiff neck & pain across shoulders. Couldn't move them at all & couldn't even turn over in bed, so lack of sleep for the first five days. The pain eventually went away, but neck still a bit stiff. I took every OTC medication I had in the house...Tylenol, Advil, Aleve, Motrin, etc. & heating pad & ice packs. Only the ice packs gave me temporary relief.
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| 75 | 2021-02-17 | excessive sleepiness, disturbance in attention |
Severe pain in muscles, bones, stomach and intestines. Severe chills, to the point that the chatter...
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Severe pain in muscles, bones, stomach and intestines. Severe chills, to the point that the chattering chipped a tooth. Diarrhea, vomiting, to the point that I was unable to keep even water down for about the first 36 hours. The shaking subsided, but the chills and severe muscle pain continued for three days. My bowels are still painful after three full days, but skin and muscle pain has subsided. During the three days of pain, I slept about 20 out of 24 hours. When awake, I tried to read but was unable to concentrate. Same for TV.
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| 75 | 2021-02-17 | restlessness, insomnia |
Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue...
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Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown. Information on the batch number has been requested.
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| 75 | 2021-02-18 | disorientation, insomnia |
Felt like my metabolism was racing - couldn't relax to go to sleep. When that stopped, aches at all ...
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Felt like my metabolism was racing - couldn't relax to go to sleep. When that stopped, aches at all sites where I had previous injury - knee replacement, other knee, fingers that locked. Felt fuzzy and tired the next day 2/18/2021. Felt normal by 2/19/2021.
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| 75 | 2021-02-18 | fear |
Patient arrives to obs; PT states patient felt lightheaded. Patient reports feeling high, VS 212/98...
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Patient arrives to obs; PT states patient felt lightheaded. Patient reports feeling high, VS 212/98,C 127, 100% frightened breathing shallow and quickly. Emotional support given, transported to stretcher. BP 189/104 hr 105 99% awake and alert. Continues to repot lightheadedness. She states walking down from vaccination she had an aura type experience. 10:50 BP 214/97HR 104, 99%, Respiratory arrived. Followed by MD and IV nurse. 10:55 213/88 HR92 99%. Transferred to ER by IV Nurse and administrator.
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| 75 | 2021-02-20 | loss of personal independence in daily activities |
Extreme debilitating Fatigue and Nausea, Saw doctor at time started but was advised to wait and ca...
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Extreme debilitating Fatigue and Nausea, Saw doctor at time started but was advised to wait and call him back in two weeks.. Will call him 02/22/2021 This is horrible and has totally kept me from performing most of my daily activities. It has now been three weeks with no relief.
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| 75 | 2021-02-21 | anxiety |
She felt hypotensive. She states that she felt that her BP was increasing. Average range is 160/170 ...
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She felt hypotensive. She states that she felt that her BP was increasing. Average range is 160/170 systolic. Felt anxious prior to vaccine. Denied SOB, difficulty breathing, denied chest pain or dizziness. 15:35 VS 187/72 and HR 69. 16:17 VS 212/94 HR 71 RR 14 and o2 sat 100%. Brought patient to our express symptom management unit.
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| 75 | 2021-02-21 | confusional state |
Patient was admitted due to confusion and poor oral intake most likely due to esophageal spasm. Pt r...
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Patient was admitted due to confusion and poor oral intake most likely due to esophageal spasm. Pt remains hospitalized at this time
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| 75 | 2021-02-23 | disorientation |
Patient complained of lightheadedness with slight disorientation, chest heaviness. Patient transpor...
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Patient complained of lightheadedness with slight disorientation, chest heaviness. Patient transported to ER for further evaluation & treatment.
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| 75 | 2021-02-24 | anxiety |
Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathin...
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Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathing, pain, or other complaints voiced. EMS evaluated the patient on-site. The patient was hypertensive (208/103). EMS noted that the patient was visibly anxious and that they elected to be transported to Emergency Department for evaluation. When contacted for medical records, ED stated that the patient never was checked into the hospital and did not have records available. Assumed lost to follow-up.
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| 75 | 2021-02-24 | disorientation |
Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: redu...
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Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: reduction in flu like symptoms but disoriented and lethargy and headache Day 5: disoriented and lethary Day 6: same Day 7: shakey and lethargic Day 8: same
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| 75 | 2021-02-24 | feeling abnormal |
Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore thro...
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Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore throat, fever: 98.9-99.9, fatigue
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| 75 | 2021-02-25 | sleep disorder | Really bad headache and need to sleep for at least 36 hours. No treatment. |
| 75 | 2021-02-27 | feeling abnormal |
Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feel...
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Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feeling pressure in the head I have observed Patient having red face itchy face foggy pressure in the head. Vital signs: 0843 BP 170/80 HR 96 RR 18 Pulse Ox 98% 0846 BP 182/80 0857 BP 168/84 HR 88 RR 16 Pulse Ox 97% 0910 BP 180/90 HR 88 RR 16 Pulse Ox 97% 0925 BP 200/90 HR 88 RR 16 Pulse Ox 97% Treatment/intervention Monitored offered water Benadryl 25 mg po @ 0850 by an RN, Benadryl 25 mg po @ 0914 by an RN 0925 patients BP continued to be out of normal range patient stated that she took her BP medications this am. Face still flushed. 0925 ambulance called to transport patient to the ED. 0925 ambulance her report given.
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| 75 | 2021-02-28 | loss of personal independence in daily activities, feeling abnormal |
hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling ki...
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hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling kind of weird, off balance; Upset stomach; Chills; She cannot function very good, She is feeling so bad and cannot do nothing; At night time it is hard to try to do something and she cannot do it because she is tired; can hardly breathe at night; it kind of feels like she has an ear ache but she does not have an earache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via intramuscular route of administration on 14Jan2021 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) from an unknown date (per patient diagnosed quite a while ago and she goes to a pulmonary doctor). Concomitant medications included unspecified inhaler at two puffs per day if needed and unspecified recue inhaler one puff a day as needed, both ongoing for one year for COPD. The patient did not receive any other vaccines within four weeks prior to the vaccination or any other prior vaccinations or any vaccinations on the same date of the vaccination. The patient experienced chest pain, feeling abnormal, feeling off balance, upset stomach, chills, cannot function very good, tired, can hardly breathe at night and ear discomfort, all in Jan2021. The patient reported she received the vaccination on 14Jan2021 by her primary doctor. She is feeling kind of weird and has an upset stomach. She is asking how long this will last. She is worried about taking the second dose. She is supposed to have the second dose on 04Feb2021. She cannot function very good, states it kind of feels like she has an ear ache but she does not have an earache. Her balance is off and she can hardly breathe at night. All her symptoms started on the third day after getting the shot (Jan2021). She reports the feeling weird and off balance feeling feel like you are drunk. It aggravates her because she cannot function right. She also experienced chills started the third day after the shot and the chills have recovered completely. The patient reported that she was alright the first day. She has hurting in her chest, like she has to keep breathing which also started the third day after getting the shot and has been going on all this time. At night time it is hard to try to do something and she cannot do it because she is tired, states it is the worst part, She is feeling so bad and cannot do nothing. She has a hard time breathing. The events did not require a visit to emergency room or physician office. The patient did not have any relevant tests. The clinical outcomes of the events chest pain, feeling abnormal, feeling off balance, upset stomach were not recovered. The patient recovered from the chills in Jan2021. The outcome of the cannot function very good, she is feeling so bad and cannot do nothing, tired, can hardly breathe at night and ear discomfort was unknown.
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| 75 | 2021-03-02 | anxiety |
Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had g...
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Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had generalized itchy fore head ,bilateral eyes, throat and ears. Vital signs within normal. Patient was placed in recumbent position and was given apple juice. Patient stated all symptoms resolved at1312 and was discharged home.
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| 75 | 2021-03-02 | feeling abnormal |
Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This ...
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Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
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| 75 | 2021-03-03 | feeling abnormal |
dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd fe...
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dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd feeling all over, fatigue
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| 75 | 2021-03-07 | sleep disorder, anxiety |
I had no side effects up until 3 days later, 02/25/2021, during lunch my heart started racing and po...
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I had no side effects up until 3 days later, 02/25/2021, during lunch my heart started racing and pounding and I could not catch my breath. I tried to relax and eat and I felt like I had indigestion coming on. Then I started feeling very mild tightness in my throat. Later I had mild ringing in my ears. i had intense anxiety from the time my heart started pounding. ALL of these symptoms lasted for 3 days and It only happened when I ate food. I tossed and turned all night and my body was very uncomfortable and I was still extremely anxious. I started getting better after 3 days and took about 9 days to finally start feeling right. Doctor gave me an EKG and said it was fine but sent me to a cardiologist. I had another EKG, ECHO, 24 hour Monitor with a Holter, and a stress test. results pending. PLEASE NOTE: I am allergic to Cipro and I found that there is a common ingredient in Cipro and the Covid vaccines: Polyethylene Glycol Maybe there's a correlation?
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| 75 | 2021-03-09 | insomnia, feeling abnormal |
nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, bra...
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nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, brain fog, rosacea,
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| 75 | 2021-03-09 | loss of personal independence in daily activities |
Severe arm pain going down to hands and fingers.; could not unfold elbow or arm due to pain; She cou...
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Severe arm pain going down to hands and fingers.; could not unfold elbow or arm due to pain; She could not dress b/c the feeling of clothing in arm was excruciating.; This is a spontaneous report from a consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 02Feb2021 08:00 at single dose for covid-19 vaccine. Medical history included diabetes and hypertension. Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had severe arm pain going down to hands and fingers on 02Feb2021 at 18:00. She had severe sensitivity. She could sleep due to pain but could not unfold elbow or arm due to pain. She could not dress b/c the feeling of clothing in arm was excruciating. She was in tears. It was been about 5 days and the pain and sensitivity has increased every day. Patient had taken paracetamol (Tylenol), ibuprofen (Advil) went to my primary and got prescribed tramadol for pain. Nothing was helping. Patient visited doctor or other healthcare professional office/clinic visit due to events. She did not have COVID tested post vaccination. The outcome of events was not recovered. Information on batch number has been requested.
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| 75 | 2021-03-13 | disturbance in attention, feeling abnormal |
1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, ...
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1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, injection site got red, swollen, had hard knot, and deep itch at injection site right arm. On third day started getting brain fog, had hard time concentrating and felt extremely tired. Redness, swelling, hard knot, and deep itching has gone away. Still have a bit of brain fog but getting better. Knee joints are hurting. I got most of my energy back. It took 9 days for redness and swelling to go down. I did not seek treatment for symptoms.
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| 75 | 2021-03-15 | excessive sleepiness, incoherent |
She slept for 30 hours and was not answering her phone. She was completely incoherent when my Husba...
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She slept for 30 hours and was not answering her phone. She was completely incoherent when my Husband went to check on her. An ambulance was called and she was in hospital for two nights.
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| 75 | 2021-03-16 | feeling abnormal |
pt states that she starts nodding on and off due to extreme fatigue. She doesn't feel well and has...
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pt states that she starts nodding on and off due to extreme fatigue. She doesn't feel well and has trouble walking says she thinks its because her muscles are hurting. She says she doesnt feel right but doesnt know how to describe. Pt states she has had these symptoms going on about a month.
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| 75 | 2021-03-17 | feeling abnormal |
Had the vaccine, had no reaction until a few days later when she had dizziness, also waviness, loss ...
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Had the vaccine, had no reaction until a few days later when she had dizziness, also waviness, loss of stability. She went to 3 doctors, ENT and he gave her a steroid Methylprednisolone which did not help after two rounds of it. Then he sent her to a neuro/Otolaryngologist. She is still having the same symptoms.
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| 75 | 2021-03-17 | excessive sleepiness |
Fever, body aches, fatigue loss of appetite; treated with ibuprofen and Oxycodone IR 5mg tab CII; re...
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Fever, body aches, fatigue loss of appetite; treated with ibuprofen and Oxycodone IR 5mg tab CII; rest (slept for almost 48 hours) Symptoms, except fatigue, pretty much gone in 48 hours
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| 75 | 2021-03-18 | insomnia |
Unable to sleep; Gas from both ends; Stomach cramps; Constipation; Her injection arm is sore; This i...
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Unable to sleep; Gas from both ends; Stomach cramps; Constipation; Her injection arm is sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 11Feb2021 15:30 as single dose for COVID-19 immunisation (because of the pandemic and she is 75). Medical history included being diabetic. Concomitant medications included warfarin and varicella zoster vaccine taken for an unspecified indication, start and stop date were not reported. The patient previously had a flu shot back in Oct2020 and experienced sore at the injection site. The patient was unable to sleep last night due to stomach cramps and constipation. It has been horrible. Worst part was gas from both ends. The events began 9PM or a little earlier on 11Feb2021. The patient also reported that her injection arm was sore on Feb2021. This is the first time she has had a reaction like this and not been able to sleep. Asked if she should drink some lemon water, take a laxative, or what to do. Advised the patient to follow up with primary care physician for treatment recommendations. The patient underwent lab tests and procedures which included blood pressure: 124/78 and A1C: 5.9 on an unspecified date; international normalised ratio (INR): 424 on 08Feb2021. The outcome of the event her injection arm was sore was unknown and not recovered for the rest of the events.
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| 75 | 2021-03-18 | loss of personal independence in daily activities |
6 hours after 2nd dose of vaccine I could feel my body starting to react. Aches and pains increased...
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6 hours after 2nd dose of vaccine I could feel my body starting to react. Aches and pains increased as the time went on. I went to bed and around 12 hours after the injection I got a headache that was unbearable. It felt like someone was hitting my head with an ax. The pain was excruciating. I went through the night with the pain feeling like my head would explode. In the morning I was totally exhausted and my body hurt all over. I took Tylenol and went back to bed. Put warm cloths on my head and face. My sinus hurt, my teeth hurt. my throat hurt. my eyes hurt. Awful!!! Spent the entire day in bed. I continued taking Tylenol every 6 hours. It did help a little. By Friday I was seeming to feel a little better. Still have mild headache and body aches and stomach upsets; but better than the first 24-36 hours. Hoping to continue to improve each day. Never expected any side effects as severe. Most people said sore arm and feeling tired. I do hope the worse is over.
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| 75 | 2021-03-21 | confusional state |
Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chil...
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Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission. Placed on NIPPV, steroids, convalescent plasma and antibiotics. Patient died 2/24/2021
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| 75 | 2021-03-23 | insomnia, abnormal dreams |
During the night about 12-14 hours after receiving the vaccine, I work up dreaming of people who wer...
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During the night about 12-14 hours after receiving the vaccine, I work up dreaming of people who were complete strangers and I knew nothing about what they were doing in the dream or why I was there. It made me wonder if the vaccine was having some effect on my brain. I also woke up at least 8 times during the same night with my mouth so dry it almost had no feeling in it. Neither of these events has ever happened to me before. I don't dream about strangers and I don't wake up so frequently needing water. So I don't know what to attribute it to except the vaccine since it was the only thing different. I had a sore arm with the first dose but that was all that happened.
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| 75 | 2021-03-24 | disorientation |
all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, d...
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all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-30 | confusional state |
Patient recieved first dose of COVID vaccine and left the clinic at 12:20. By 1300 patient was very...
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Patient recieved first dose of COVID vaccine and left the clinic at 12:20. By 1300 patient was very confused and unable to answer questions. Patient was taken to the hospital and was diagnosed with a Non-Traumatic Intracranial Hemorrhage
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| 75 | 2021-03-30 | feeling abnormal, disturbance in attention |
Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headach...
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Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headache; nausea; Muscle heaviness; fatigue; brain fog(poor concentration and focus); brain fog(poor concentration and focus); general malaise; Increased bowel movements daily; This is a spontaneous report from a contactable pharmacist (Pharmacist). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: El8982), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as single dose for covid-19 immunisation at Health Clinic or administration facility. Medical history included gastrooesophageal reflux and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included pravastatin taken for an unspecified indication, famotidine, ascorbic acid, betacarotene, colecalciferol, folic acid, minerals nos, retinol, tocopheryl acetate, vitamin b nos (CENTRUM [ASCORBIC ACID;BETACAROTENE;COLECALCIFEROL;FOLIC ACID;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS]), cyanocobalamin (B12), ergocalciferol (VIT D). The patient previously took biaxin and experienced drug hypersensitivity. On 27Jan2021 20:00, the patient experienced lung tightness with burning and pain/lungs were tight, headache, nausea, muscle heaviness, fatigue, brain fog (poor concentration and focus), general malaise and increased bowel movements daily. These symptoms lasted for 7 days. Two of the days my lungs were tight but I did not have shortness of breath. Nausea was everyday. Increased bowel movements daily. I am concerned that these effects lasted for 7 days. Does this put me at risk for serious side effects after the 2nd dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was recovering.
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| 75 | 2021-03-30 | feeling abnormal |
This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer...
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This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 05Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), depression, both hips replaced and allergic to sulfur. Concomitant medications included ibuprofen, blood pressure and depression pill. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization and experienced mild arm soreness. The patient received her second Pfizer COVID vaccine on 05Mar2021 at 1 PM. The following morning on 06Mar2021 she woke up at 6:30 AM with an itchy rash on her buttocks and hips. She took diphenhydramine (BENADRYL) and it subsided but came back later and started spreading to her thighs, chest, arms, stomach, and back. She was taking Benadryl to treat it and wanted to know what else to do. She was covered with a rash and itching and going crazy, they were welts like little welts kind of hives; It is itching all over; It didn't go away, it was itching all through the day. It just kept getting more and more in covers like her knees up to her butt, her butt was all covered, her lower back was covered and her arms were getting it now that just keep travelling. It is all around the area, it's travelling everywhere my legs, my arms and my chest. The patient had the 2nd dose yesterday (05Mar2021). She experienced little soreness on her arm and rashes starting to spread all over to her body after the vaccine. Outcome of the events going crazy and little soreness on her arm was unknown while not recovered for the other events. Information on the lot/batch number has been requested.
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| 75 | 2021-03-30 | restlessness |
upset stomach; she felt restless; Chills; fever; Nausea; Vomiting; diarrhea/Loose bowels; Fatigue/wo...
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upset stomach; she felt restless; Chills; fever; Nausea; Vomiting; diarrhea/Loose bowels; Fatigue/woke up tired; Achy; sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 75-years, on 04Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number: EJ1686), via an unspecified route of administration in left arm at the age of 75-years, on 14Jan2021 at a single dose for COVID-19 immunisation. The patient received 2nd dose on Thursday (04Feb2021). The patient began experiencing symptoms/side effects Saturday night (06Feb2021): chills, fever, nausea vomiting, diarrhea, fatigue, and achy. The patient said she got her second shot of vaccine on Thursday (04Feb2021). She said after she got the second dose of the vaccine, Friday (05Feb2021) she felt fine other than the sore arm and then yesterday on 07Feb2021, she woke up tired with chills, fever, and nausea. She says she would like to know if someone can show symptoms later after getting the vaccine. She says she is feeling ok today, but yesterday was horrendous. She says anyway, she is not doing anything but drinking water now. She says she felt fine the second day after the vaccine so she can't understand why she felt this way later, and doesn't know if it could be the second dose of the vaccine or something else. The patient said that that she had her shot on Thursday at noon, then Friday through Saturday night she was fine then she woke up yesterday morning (07Feb2021) with an upset stomach that caused her to throw up. She said she was up through the night (Saturday night) because she felt restless and knew something was wrong. She said her treatment was that she laid on the sofa under blankets and sipped ginger ale and water all day yesterday. She says besides throwing up the one time, she had loose bowels all day long Sunday and then today too, but she doesn't have anything on her stomach today other than a half a piece of toast. She said she felt better today, and had no chills or fever. The patient said she attempted to take her temperature, but she couldn't read her thermometer. The outcome of the events chills, fever, and nausea was recovered on an unknown date in Feb2021, and it was unknown for other events.
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| 75 | 2021-04-01 | anxiety |
Approximately 10 minutes after receiving 2nd Covid 19 vaccine, patient reported not feeling well. S...
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Approximately 10 minutes after receiving 2nd Covid 19 vaccine, patient reported not feeling well. She was assisted to a cot where she was able to lie down. VS taken: Pulse-101, O2 sat 99% bon 2L/min of Oxygen, BP 135/87. At 12:30 she was anxious and began to c/o tightening of the throat and 0.3mg of epinephrine was administered IM into the right leg via auto injector by RN per protocol. EMS was at the POD site and monitored until she was transported to the emergency department by ambulance.
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| 75 | 2021-04-01 | insomnia, feeling abnormal |
Client reports that, she has experienced clogged of the ears, also ringing the ears, feeling really ...
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Client reports that, she has experienced clogged of the ears, also ringing the ears, feeling really bad, difficulty sleeping, with elevated tinnitus.
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| 75 | 2021-04-02 | sleep disorder |
I am feeling unusually weak and fatigued but what is bothering me even more is a ?deep sighing? felt...
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I am feeling unusually weak and fatigued but what is bothering me even more is a ?deep sighing? felt more like a skipped breath. Is this an unusual report. It is really weird. I mentioned to my daughter who also got the Pfizer and she said I should take deep breaths but then it keeps coming back.. I had a visit with another doctor 2 days ago and I did mention it. He asked about other s/s like SOB and I said no. But this deep sighing even wakes me up at night. What do I do?
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| 75 | 2021-04-04 | confusional state |
A phone call was made to the patient a couple days after her second vaccination and she reported tha...
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A phone call was made to the patient a couple days after her second vaccination and she reported that she had experienced dizziness, confusion, body aches and chills starting the night of her vaccination.
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| 75 | 2021-04-06 | disturbance in attention |
The day of the vaccine: very tired, and not able to focus well. Then almost 11 days later. Happened ...
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The day of the vaccine: very tired, and not able to focus well. Then almost 11 days later. Happened 10.5 days after the vaccination: Extreme fatigue for 3.5 days, beginning April 3, 2021; April 6, evening: pounding heart for about 15 minutes, feverish, nausea, threw up; Took 2 tums, then 3 baby aspirin, and went to bed. Slept well . OK now.
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| 75 | 2021-04-06 | disturbance in attention |
Sore muscle in neck, extreme muscle pain in both legs, nausea, headache, fever, dizzy, unable to con...
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Sore muscle in neck, extreme muscle pain in both legs, nausea, headache, fever, dizzy, unable to concentrate, taste obstructed and extreme tiredness
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| 75 | 2021-04-15 | sleep disorder |
Did not sleep well, woke with arm pain at 6am. Pt was fatigued and developed a worsening H/A as day ...
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Did not sleep well, woke with arm pain at 6am. Pt was fatigued and developed a worsening H/A as day progressed. Felt she had a mild fever with nausea. Did not feel hungry and avoided eating. Progressed throughout day, took acetaminophen 500mg and rested around 5:30pm. Ate a banana with medication, took a nap and reported feeling better.
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| 75 | 2021-04-16 | feeling abnormal |
felt like a mad truck had hit her/she feels horrible; low grade fever; This is a spontaneous report ...
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felt like a mad truck had hit her/she feels horrible; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9267, Expiration date: unknown) via an unspecified route of administration on 15Feb2021 at single dose for COVID-19 Immunization. Patient medical history included Covid in last October. Concomitant medication was not reported. Patient stated that she already spoke to a Nurse about the side effects she experienced before she was transferred . The patient reported that she received first dose of the vaccine yesterday and at first, she felt fine but on 16Feb2021 when she woke up, she felt like a mad truck had hit her. The patient also had low-grade fever; it was very unusual for her as she usually an energetic person. Patient took lowest dose of Tylenol for events and was not sure whether it was ok to take any medications with the vaccine since she saw some add on TV about the side effects. The patient added that she was expected to experience these side effects after taking her second dose of the vaccine not after first dose. Also wanted to know if the side effects she experienced right now could possibly be related with her having Covid last October. Patient also reported that she disappointed with the information provided to her, as she expected little bit more help. The patient wanted to have information on the effects of the vaccine on people who previously had Covid. Patient confirms saw the Pfizer COVID 19 vaccine. She also saw the batch number EL9267. She does not see and expiration date or NDC number. Patient went to bed after her vaccination and she felt fine, life was normal but when she woke up this morning, she felt horrible. The product complaint was reported. The outcome for the events was unknown. Upon follow-up on 16Feb2021: This is a follow-up spontaneous report from a contactable consumer included Patient age, weight, height, lot number of suspect products, events with onset date. No follow-up attempts possible. No further information expected.
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| 75 | 2021-04-17 | anxiety |
Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really so...
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Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really sore; Some choking; Anxiety; Cough during treatment; This is a solicited report (MARKETING PROGRAM NAME NOT AVAILABLE) based on the information received by Pfizer pharmacy. A contactable 75-year-old female consumer (patient)received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation; and treprostinil sodium, via inhalation from 12Feb2021 (Batch/Lot number was not reported) to an unspecified date and at 18-54 ug, 4x/day, via inhalation from an unspecified date (Batch/Lot number was not reported), at 36 ug, 4x/day for pulmonary arterial hypertension. Medical history included ongoing anxiety. The patient's concomitant medications were not reported. In Feb2021, the patient experienced event of cough during treatment. In 2021, the patient experienced event of gagging (retching). On 04Mar2021, the patient experienced event of anxiety; related it to going to the physician appointment. An additional dosage regimen of 36 ug (6 breaths), qid via IH route was added to Tyvaso. The patient reported that coughing (previously reported as cough) and gagging had improved after the treatment. The patient's current IH Tyvaso dose was 6 breaths four times a day. On 04 Mar 2021, 2 weeks 6 days after initiating IH Tyvaso, the patient had anxiety and related it to going to the physician appointment. The patient had reported ongoing anxiety since childhood. In 2021, the patient experienced the event of some choking. In 2021, the patient experienced the events of feels tired and sleepy all the time and arm was really sore (pain in extremity). The patient felt tired and sleepy all the time. Her arm was really sore and she was tired and sleepy. The outcome of the event cough and gagging was recovering while the outcome of the rest of the events was unknown. The action taken in response to treprostinil sodium for the events was unknown. An unspecified treatment was given to the patient for the event cough and gagging. The reporter assessed the causal relationship between the IH Tyvaso and the event of cough as possible. The reporter did not provide causality for the events of retching, choking, anxiety, fatigue, somnolence, and pain in extremity. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of choking,cough,gagging,and other events cannot be excluded but also contributory effect from other suspect drug TREPOSTINIL SODIUM. consider also possible contributory effects from patient's medical history and concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-04-19 | disturbance in attention |
Change in level of alertness. Per vaccinator assistant (relative of client)- Not acting her normal ....
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Change in level of alertness. Per vaccinator assistant (relative of client)- Not acting her normal . Per client- tired/ unable to concentrate, feels flush and pale. VD 9:40AM HR99, O2 99%, BP 116/60, BS 175. VS bp 109/66, hr 93, r14 Cincinnati- Negative. Went home with family. Instruct to contact PCP, and if unchanged to go to ED.
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| 75 | 2021-04-23 | sleep disorder |
fell; injured her back; couldn't sleep; This is a spontaneous report from a contactable consumer. A ...
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fell; injured her back; couldn't sleep; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) (This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected) via an unspecified route of administration on 26Jan2021 at 11:30 (at the age of 75-year-old) as SINGLE DOSE for an COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient states that sometime during the afternoon that same day of the vaccination, she was carrying boxes and fell and hurt her back, the pain is excruciating, injured her back. She said that it was hurting so bad and she couldn't sleep. She said her daughter told her to not take Aspirin or Tylenol because it would compromise the vaccine. She wanted to know if that was true. She was wondering if there was a time limit to when she could start to take something to alleviate the pain and if she has compromised the effect of the vaccine by taking that. Consumer states that before her daughter told her that she cannot take those medications, the consumer did take two Tylenol for her backache on last night 17Jan2021 and not taken any more since, and she was sitting there with a heating pad and she had limping around dying. Consumer states that at first, she thought her back ache might have been muscle pain following the shot, but she was putting Christmas stuff away, and it just kept getting worse. She states that she does not think the back pain has anything to do with the shot, she had been taking boxes up and down stairs, and caller states that her daughter is a nurse, and her daughter told her that she just had a back injury, and that she just needs an Aspirin or something. she states that she had no other complaints since getting the shot, except her stupid back. Consumer states that after taking the Tylenol, she has been hoping that she did not compromise the vaccine. On unspecified date of Jan2021, the patient experienced fell, injured her back and couldn't sleep. Therapeutic measures were taken as a result of injured her back treatment included with two Tylenol and with a heating pad. The outcome of the event was unknown. Information on lot number/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 75 | 2021-04-27 | amnesia |
4/25-headaches, nausea, vertigo, bouts of memory loss. Nausea has resolved. Patient planning on maki...
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4/25-headaches, nausea, vertigo, bouts of memory loss. Nausea has resolved. Patient planning on making appointment with physician sometime this week. Advised for patient to stay hydrated.
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| 75 | 2021-05-07 | feeling abnormal |
having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; Th...
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having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included breast cancer/her breast cancer had came back in the same place from 2006, both breasts removed on 2006. Concomitant medication included palbociclib (IBRANCE) taken for breast cancer female from 24Jun2020 to 04Feb2021 then from 01Apr2021 and ongoing. The patient previously received the first dose of bnt162b2 (lot number: EL3248) on 17Jan2021 for COVID-19 immunization and experienced acute bronchitis. On 14Feb2021, the patient was taken by an ambulance and was hospitalized because she couldn't breath, they thought she was having a heart attack, her lungs were filled-up with fluid. The doctors had her on oxygen while she was in the hospital, and did heart and lung tests on her on an unspecified date in 2021. While in the hospital, the patient felt like a pin cushion on an unspecified date. The patient left the hospital on 17Feb2021. The patient was tested for COVID-19 three times on unspecified dates all with negative results. the patient was hospitalized again on 25Feb2021 to 01Mar2021 for reasons not reported. The outcome of the events she couldn't breath, thought she was having a heart attack, her lungs were filled-up with fluid was recovered on 17Feb2021, while for the event felt like a pin cushion was unknown.
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| 75 | 2021-05-07 | feeling abnormal |
Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side ...
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Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side from her foot to her neck; Sore Left Arm; Chills; Wasn't feeling herself; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; This is a spontaneous report received from a contactable nurse (Patient herself). A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via unknown route of administration on 03Apr2021 (Lot Number: ER8729, Expiry date: Jul 2021) as single dose for COVID-19 immunization. The patient medical history was breast cancer. The patient historical vaccine included BNT162B2 on (LOT:EJ1686 Expiration: 31MAR2021) on 13 Mar 2021 for COVID-19 immunization. The patient had no family history. The patient concomitant medications were not reported. The patient experienced chills on 04Apr2021, sore left arm on 13Apr2021, Rash on the left side of her face; itchy; face felt like it was hot on Apr2021, chills on her left side from her foot to her neck: on 17Apr2021, Tiredness on an unknown date and tightness in her left leg that felt like a tunicate was left on 17Apr2021, wasn't feeling herself Apr2021. The patient stated she wanted to send pictures of her rash on her face that her dermatologist diagnosed last Tuesday as a Covid Vaccine side effect. She had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. They were both done at (withheld). With the first, she had no side effects, other than a sore left arm. The second she had a sore arm and a couple of chills at first. Then two weeks post second vaccination she wasn't feeling herself, and she went to see a primary about that, but that wasn't a definite that it was side effects from the vaccine. Then, the following week on a Thursday she got a rash about the same time but it was getting itchy so she decided someone should look at it. At first she thought it was from her mask, but it was only on the left side of her face. Caller states she wrote a message to her doctor about not feeling well but she didn't connect all of the other symptoms. She went to her primary for the chills on her left side from her foot to her neck and just not feeling like herself. She had a tightness in her left leg that felt like a tunicate was left on. Her face felt like it was hot. States it was really very weird and she was very tired. The tiredness comes and goes. States she was doing interviews yesterday for a long time, virtual interviews and by 12 noon she felt so tired and took a nap and felt out of sorts. She Didn't show her the rash because she thought it was just from her mask and she wasn't a dermatologist. Didn't mention it to her primary. States she tried to cancel the appointment but said she needed to come see her anyway. Thursday she had another appointment so she called the dermatologist when it started to itch and she said to the office, should she be worried. At first, said no time, and reported to doctor and fit her in at 13:30 and she looked at it and said it is really impressive for being 2 weeks old and thinks it is Covid vaccine related. Didn't know if she should report it or not. Maybe it is something. Was thinking the Covid rash was extensive. She still has the tiredness. It reminds her of the tiredness she had after radiation for breast cancer. States it wasn't during the radiation, but 4-5 weeks later and lasted about a month. States the tiredness is not from a lack of sleep, it is like a veil comes over her. States if she has taken 10 naps in her whole life, that is a lot for her and that didn't help. Treatment: Gel for the Rash; states for her leg issue the doctor ordered an MRI to rule out a back or disc problem. States she didn't put it together, one said it might be and another side not sure. At first she was offered the Moderna and she changed when they offered the Pfizer, because of the breast issues from the Moderna. Curious to see at some point if point if other people are experiencing rashes on their faces. Caller states she didn't know what type of rash was common, she assumed it was more of a bodily rash. Tetanus back in the Fall or maybe July thinks last July, she had GI stuff and her physician wasn't particularly believing it was from that. The event tiredness wsa assessed as serious (Medically significant), and tightness in her left leg that felt like a tunicate was left considered serious (Disability). The all other events were assessed as non-serious. The patient had physicians room visit (PCP and dermatologist) and not had emergency room visit. The causality assessment was unknown for all events. The outcome of the event rash on the left side of her face; itchy; face felt like it was hot and tiredness was not recovered, The outcome of all other events was recovered. Additional information requested.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-05-07 | insomnia, feeling abnormal |
rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in...
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rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in her throat one side, injection on the right side, just in the right peritonsillar fossa; very foggy; trouble sleeping; numbness; paresthesia; Shingles; Rash around her eye; Sore throat; Earache; This is a spontaneous report from a patient. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EN6201) as a single dose (at the age of 75 years) for covid-19 immunization. The patient's medical history included lung Cancer from Aug2010 to Oct2010 (lung cancer survivor and had 35 days of treatments, 20Sep2010 was her last day of treatment. She says the end date for this condition was mid Oct2010, she has inoperable lung scarring, it's not COPD, more like a seasonal allergy, when she runs into an URI they up the prednisone to stop the spasms. She clarifies that URI stands for upper respiratory infection; ongoing sleep obstructive sleep apnea (patient uses a CPAP. She says she has had this condition prior to 2010, since the early 2000's), polymyalgia rheumatica from 2019 and ongoing,ongoing hypothyroidism (had this condition for 30 years probably) , hypertension from Feb2021 and ongoing; gastrooesophageal reflux disease (since the 1990's), chemotherapy and radiation (chemotherapy and radiation 10 years ago), postmenopausal and inoperable lung scarring from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE) taken for polymyalgia rheumatica from; budesonide, formoterol fumarate (SYMBICORT) taken for lung neoplasm malignant; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for lung neoplasm malignant; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastrooesophageal reflux disease; levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for postmenopause from an unspecified start date and ongoing; ascorbic acid (VIT C) taken for postmenopause; hydrochlorothiazide (HYDRODIURIL) taken for hypertension from Feb2021 to an unspecified stop date. The patient received the first dose of BNT162B2 (lot:EL9262) in the left arm on 21Jan2021 at the age of 75 years for Covid-19 immunization. The patient experienced shingles, rash around her eye, sore throat, earache on 29Mar2021; numbness, paresthesia and trouble sleeping on 31Mar2021; very foggy on 03Apr2021; very foggy was reported as worsened/ trouble sleeping was reported as worsened, rash on her scalp, flat macular rash, on her scalp the vesicles were breaking out basically, pain in her throat one side, injection on the right side, just in the right peritonsillar fossa on an unspecified date. It was further reported that 5 and a half weeks later (after the vaccine) she developed shingles. She said it just recently came to her attention and might be related to the vaccine, but she was not sure if it was or not. She said she has not had the shingles vaccine, she had chemotherapy and radiation 10 years ago and never had any issues so she never got the vaccine for shingles. Patient is on a dose of gabapentin 800mg for the shingles, she has had a lot of difficulty with the dose and the shingles, She said she was little bit fuzzy, but that's probably because of the gabapentin, not the vaccine. Patient also mentioned she had a sore throat, it involves the right forehead, scalp, neck, she has an earache. She said the earache and the sore throat have passed but she still has the issue around her eye, a rash. She said the numbness and paresthesia started, she didn't pay much attention to it, then 2 days later she thought she should see the doctor. She says she saw a rash on her scalp, she didn't see the vesicles right away, she saw a flat macular rash. She says on her scalp the vesicles were breaking out basically. She says the sore throat has been interfering with her sleep, she can't use her CPAP, it got to disabling because she can't use her CPAP. She was very foggy. Trouble sleeping was medically significant moving into disabling because she was really foggy, more foggy as she goes along. She says the foggy is medically significant moving towards disabling, that up until today it was medically significant. She said for her throat she had to gargle a lot, it didn't go away with Tylenol. Tylenol NDC, lot, and expiration date not provided. She says the earache was there, it was annoying. She said the trouble sleeping was related to the shingles, she can't say the vaccine did it. The patient underwent lab tests and procedures included bloodwork on 02Apr2021 and everything came back normal. She said that was to test her kidney function following the HydroDiuril. She said the HydroDiuril was changed from 25mg to 12.5mg. She says she also had a screen of her inflammation markers of her lungs and that that was normal. She says both tests were done on 02Apr2021, that was the last ones, not the first ones done. The patient went to her doctor and ophthalmologist and was prescribed Valtrex. She does not know the dose and frequency, she says it is an antiviral for shingles. She says the gabapentin was for the pain for the paresthesia. The gabapentin was fluctuating, they keep increasing it due to discomfort, and she was up to 800mg in divided doses. She said she also was given eye drops, triple antibiotic polymixin. She had neomycin and another one, that it was the same as the ointment triple antibiotic for abrasions. She used that 3 times a day in her right eye. She also took a cortisone preparation eye drops and that they are also 3 times a day in her right eye. She says her ophthalmologist put her on a second course of Valtrex, she does not know the dose or frequency, saying that it varies according to her primary care physician. She says the total is 800 mg in divided doses. She says she is doing 200, 200, 400, she is trying to get off of it but that doesn't work so they are going to be increasing it. The organ involvement included respiratory and Dermatological/Mucosal. The patient was recovering from the events shingles and rash around her eye, recovered from sore throat, earache on 19Apr2021, not recovered from the events numbness, paresthesia, very foggy, trouble sleeping, and unknown outcome for all the other events.
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| 75 | 2021-05-11 | loss of personal independence in daily activities |
The client had the 2nd dose of Pfizer BioNtech COVID vaccine on 2/19/2021. On Sunday following the ...
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The client had the 2nd dose of Pfizer BioNtech COVID vaccine on 2/19/2021. On Sunday following the injection she started to experience joint and muscle weakness from her waist all the way down her legs. She is still having symptoms which has affected her daily living and caused difficulty with tasks such as getting dressed and putting on shoes.
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| 75 | 2021-05-14 | disorientation |
blurred vision; seeing blue and pink flashes in both eyes; seeing blue and pink flashes in both eyes...
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blurred vision; seeing blue and pink flashes in both eyes; seeing blue and pink flashes in both eyes; lightheaded; tingling feeling from knees to feet; got disoriented; joints aching, knees and arms; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 06Apr2021 08:20 am (Batch/Lot Number: ENB200) as single dose at the age of 75-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. No history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). On 06Apr2021, 10 minutes after she received the vaccine, she patient experienced blurred vision, seeing blue and pink flashes in both eyes, she was lightheaded, tingling feeling from knees to feet, got disoriented, joints aching, knees and arms. The events required a visit to Emergency Room. The events were considered medically significant. The outcome of joints aching, knees and arms was recovered on 27Apr2021, of all other events was recovered on 06Apr2021. The course of events was as follows: 10 minutes after she received the vaccine, she experienced blurred vision, seeing a blue and pink flashing in both eyes, she was lightheaded, from her knees down to her feet had a tingling feeling, and she got disoriented. She told her family member something was wrong with her and they got the EMS. The EMS checked her vital signs and suggested to take her to the main campus Emergency Room center. After the knees and arms stopped tingling, different side effects came up on her as she was sitting and waiting for 15 minutes. Patient did not know how long her eyes flashed exactly, but it stopped the same day. Patient had had some differences with her legs, like her joints aching. It lasted from 06Apr2021 to 27Apr2021 until she had to go back for the next vaccine. The joint pain/achiness in legs and arm lasted for 3 weeks on and off. Patient was not hospitalized. No relevant tests performed. Patient has an appointment scheduled with her physician on following Monday. She was scheduled to go back 27Apr2021 for second dose. No follow-up attempts are needed. No further information is expected.
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| 75 | 2021-05-21 | sleep disorder, disorientation, anxiety |
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) repor...
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This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 07May2021 (at the age of 75-years-old) as 1 st dose, single for COVID-19 immunization. Medical history included feeling jittery (started before she got the COVID-19 vaccine); nervousness (started before she got the COVID-19 vaccine); stomach was hurting (feeling like her stomach was hurting all the time); anxiety (had for years/started before she got the COVID-19 vaccine); bowel obstruction in 1990; bowel syndrome; polypectomy (removed a polyp and she hasn't had any problem since then) on 26Mar2021; colon problems (has valve syndrome and suffers with that/started before she got the COVID-19 vaccine); thyroid that is kind of slow (hands tremble sometimes because of her thyroid that is kind of slow); trembling (for at least 2 years/started before she got the COVID-19 vaccine) and stomach problems (had for years/started before she got the COVID-19 vaccine). Concomitant medications was unspecified (took her regular medicine) and has all different medicine. The patient called to get information when she needed to come back. The patient was asked if she received the vaccination card, said that she did not receive it but there was a paper given for the date which was 28 May for the second dose, however there was no time indicated. The patient mentioned that she was disoriented (in May 2021) after receiving the first dose and she lost the vaccination card. On 12May2021, the patient stated that the report was not related to a study or program. In May 2021, the patient reported that she has been feeling better with her regular health problems after she got the shot. The patient just got the first dose of BNT162B2. She was there by herself and was just wondering what she should do. She took her regular medicine. She had the shot last Friday. So far she has been sleeping off and on for a couple days (in May 2021) and resting pretty well. She didn't know what to do if she should go in or just take her regular medicine as she has been doing. She will give her regular medicine time to work. She couldn't make her mind up on what to do. She got up this morning (in May 2021) and was feeling pretty good, she was stirring around then got nervous and jittery. She went through this anxiety before even before she got the vaccine. She just took one of the pills for anxiety. She got the card to find out how this shot was supposed to work and the side effects. She didn't know how to deal with it. She was stirring around maybe too much and just took her first pill of her anxiety medicine. She has all different medicine. She was getting the second shot on 24May2021. She was sitting down but she has had those attacks before the vaccine anyway. She has degenerative bone disease and a sciatic nerve in her back that was painful (in May 2021). She gets a pain shot and has one of those coming up soon. Sometimes she trembles (in May 2021). After she takes all her medicines that ceases. She hasn't eaten anything yet and has diabetes too (in May 2021). She was sitting still and talking to someone helps. She suffered with an inflamed ulcer too (in May 2021). The patient was very skeptical of different medicines and stuff. She has been on medications for years and looks for side effects with medicines. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 75 | 2021-05-27 | feeling abnormal, insomnia |
sodium was low; Intestinal problems; Trouble sleeping/difficulty sleeping; Blood pressure shot up/bl...
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sodium was low; Intestinal problems; Trouble sleeping/difficulty sleeping; Blood pressure shot up/blood pressure elevated 197/85; Feel like I'm on speed or something/felt buzzy/she didn't feel right; So tired; Headaches; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Apr2021 16:45 (Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included ongoing vertigo (diagnosed with vertigo so long ago that she can't even remember, she experiences vertigo with changes in barometric pressure when the weather was changing), ongoing arthritis a few years now, ongoing irritable bowel syndrome for a couple of years now, scar tissue in esophagus in 2019 (due to scar tissue in her esophagus, she was unable to swallow anything. and lost 33 pounds), h1n1 flu, sensitive to medications (she aren't allergic to anything, they just get side effects that they don't like), and blood pressure was really low and sick for months and blood pressure was probably low because she was dehydrated. Concomitant medications included meclizine hcl (MECLIZINE HCL) taken for vertigo, simeticone (GAS-X) and ibuprofen taken for arthritis. Patient stated that she can only tolerate half a pill of meclizine and she might take half of a 12 mg pill at noon and she's ok, but around 6:00 to 6:30 PM, the meclizine knocks her out. The patient received flu vaccine in Oct2020 and experienced several side effects. She never used to get flu shots, but then she got the H1N1 flu and her son was afraid that she might die because she got so sick. After she had the H1N1 flu, she has always gotten a flu shot. One time she got a flu shot and got side effects from it and the side effects all went away. She can't remember when she received the flu shot that she experienced side effects from or what her side effects were because it happened so long ago. Patient had the 1st dose last 18Apr2021, 20 minutes after receiving the 1st dose, she felt buzzy, blood pressure elevated 197/85 (around 17:05 to 17:10), trouble sleeping, and feeling so tired. She reported that she sat and waited for 15 minutes after receiving the Covid-19 vaccine and thought that she would stay for another 5-10 minutes. Within that time frame, it felt like something changed in her, she went up to the nurse and informed the nurse that she didn't feel right; she couldn't explain it and didn't know what it was, but something wasn't right. The nurse at the vaccination facility took her into another area and took her blood pressure; and her blood pressure had just shot up and was 197 or something like that over 85. The staff monitored her and advised to call an ambulance. She did not call an ambulance and her blood pressure did not go back to normal at the vaccination facility but she left anyway. Since then, she feels like she was on speed or something and she can't hardly sleep. Her blood pressure taken 3 different times since 18Apr2021 and her blood pressure was still high in 2021. She was so tired, so tired, and went to the physician because she could hardly even stay awake. Other than that, she had a headache in Apr2021 and has some intestinal problems in May2021. She doesn't know if the intestinal problems were brought on from the Covid-19 vaccine or not. Her headaches were not that bad and reported that her headaches come and go. Her intestinal problems came on a week and a half ago and she has intestinal problems anyway. Her intestinal problems were really different and that's why she went to the emergency room on 12May2021. She put a call into her GI (gastrointestinal) doctor because she has intestinal problems, but she couldn't figure out why her problems were different. Her intestinal problems were more intense than what she usually has. She was trying to get an appointment with her GI doctor to see what's going on and if there could be no correlation at all between her intestinal problems and the Covid-19 vaccine. Patient reported that she went to the emergency room yesterday, 12May2021, because of the intestinal issues, and her blood pressure was 181/86. She relaxed in the emergency room while she was waiting for results of some of the test; she turned off the overhead light, was resting, and nothing exciting was going on. Before she left the emergency room on 13May2021, the nurse took her blood pressure again and it was 170/82. She had gone to the urogynecologist a week ago because she was having some problems that weren't associated with what was going on following the Covid-19 vaccine. Her blood pressure was elevated there as well, measuring 165/96. She even went to her physician's office on 21Apr2021 and her blood pressure was elevated. She has never had high blood pressure and she doesn't want to be stuck taking blood pressure medications for this because she knows that's what her doctor was going to do and she doesn't want to. She inquired if the elevated blood pressure, feeling like you're on speed, difficulty sleeping, and tiredness were side effects that people were experiencing. She stated that for the first couple of days, she had no side effects at all. She received her Covid-19 vaccine on Sunday, 18Apr2021; and on Monday, 19Apr2021 and Tuesday, 20Apr2021, she thought this was great and then she began experiencing the events. She further inquired if her thyroid has anything to do with feeling the way that she feels, like she was going 1000 miles per minute. She went to see her physician on 21Apr2021 because she was so tired/ tiredness that she could barely keep her eyes open. She was waking up tired and she was still waking up tired. Her physician ran a whole panel of blood work and everything was fine. When she went to the emergency room on 12May2021, she took the blood results with her so that they didn't have to run another panel. The only thing that was different about her blood work that her doctor wasn't concerned about was that her sodium was low. Her blood pressure was normally 134/78 or something like that. There was a time where her blood pressure was really low because she had been sick for months and her blood pressure was really low when she went in the one day to see her ENT and her ENT informed her that her blood pressure was probably low because she was dehydrated. She spoke to her 2 doctors and went to the ER yesterday (as reported). Her 2nd dose was supposed to be given last 09May2021 and she told her doctor that she was not going to take it because ever since she had the vaccine, her blood pressure went up. She mentioned that she never had elevated blood pressure until she got the COVID 19 vaccine. She also mentioned that decongestant gives her palpitations. Patient was asking if these were normal reactions from the vaccine. Prior vaccinations within 4 weeks was none. Outcome of events blood pressure shot up/blood pressure elevated 197/85, feel like on speed or something/felt buzzy/she didn't feel right, so tired, trouble sleeping/difficulty sleeping was not recovered; and outcome of the rest of events was unknown. No follow-up attempts are needed. No further information expected.
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| 75 | 2021-05-28 | excessive sleepiness |
Fever bet. 100 and 101 for 4 days; nausea; chills; loss of appetite; slept a lot; diarhhea; This is ...
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Fever bet. 100 and 101 for 4 days; nausea; chills; loss of appetite; slept a lot; diarhhea; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 10:30 (Batch/Lot Number: EL 9262) as 2nd dose, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Jan2021 at 10:30 am (Batch/Lot Number: EL3246) as 1st dose, single for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Patient received other unspecified medications in two weeks. Prior to vaccination, the patient did not had Covid. The Patient did not test for Covid post vaccination. On 28Jan2021 at 12:30 pm the patient experienced fever between 100 and 101 for 4 days, nausea, diarrhea, chills, loss of appetite and slept a lot. Lab test included body temperature was between 100 and 101 for 4 days. No treatment was received for the events. Outcome of the events were recovered in 2021. Follow-up attempts are completed. No further information is expected.
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| 75 | 2021-05-31 | nervousness |
strong headaches; dry eyes; fatigue; upset stomach; the cough again changed from dry to wet but very...
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strong headaches; dry eyes; fatigue; upset stomach; the cough again changed from dry to wet but very severe; sometimes I had to cough hard that I couldn't catch my breath; my temperature went up to 99.7; could eat barely anything; she was very shaky; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the second of 2 reports from the same reporter involving the same patient. The patient experienced adverse events with both 1st and 2nd dose of the vaccine. This is for the second dose of the vaccine. A 75-year-old (age at the time of vaccination) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 18Feb2021 as 0.3ml, single dose for covid-19 immunization. Medical history included hypertension, arthritis, normally a migraine sufferer, oesophageal disorder, irritable bowel syndrome, covid-19 (in Apr-2020), feeling abnormal, pneumonia, bronchitis, breathing difficulty, cough. Consumer stated that she had something with esophagus so she was taking for digestive because she had 'IBS', in April of last year she was diagnosed with corona virus. She had little bit of breathing difficulty and bronchitis was confirmed with X-ray. Covid was confirmed two days later. About 3 weeks later she felt bad again and she had to go to the emergency room the hospital here and she had pneumonia and received very good medication (treatment) and like the five pills which they give for pneumonia and they wanted to admit her to the hospital, she was in the emergency room for 6 hours and that was enough and they made another Covid test and that was negative but it was the X-ray shown that she had pneumonia. Concomitant medications included calcium (CALCIUM), colecalciferol (VITAMIN D [COLECALCIFEROL]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). Received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FL9264), via an unspecified route of administration on 28Jan2021 as 0.3ml, single dose for covid-19 immunization and experienced fever, chills, fatigue, extremely dry eyes and felt hot, they were so dry she had to pull over on the side to drive home; arm was a little bit sore, slight headache, Ice cold hands and feet, shaky, had absolutely no appetite, she was not thirsty and very little urine output, runny nose, she had almost from years a dry cough and this one turned wet, had a very upset stomach that she could not eat or drink anything, extremely tired and it felt like she had the flu, she had a heartbeat for three days which was faster than normal and that lasted for about three days. On an unspecified date, after the second dose of vaccination the patient experienced strong headaches, dry eyes, fatigue and upset stomach, though slightly shorter in duration than she experienced following the first dose. She again had dry eyes, the cough again changed from dry to wet but very severe and sometimes she had to cough hard that she could not catch her breath after second dose. The headache had changed from the first one, it was slight headache for few days but with this it was for three or four days she had headache, her stomach was a bit upset and she could not take a pill (Unspecified Medication). Her headache was severe as if she had a helicopter in there and then extremely tired. She had to go to the bathroom, and she went to bed and thought that she was going to lay down for about five minutes, but she woke about two and a half hours later. Every step she had to walk was almost too much and then my temperature went up to 99.7 and she was very shaky. The headache lasted for about 3 or 4 days and then it was over. She has never had any side effect from any vaccine. She could not take anything for the headache because she thought she will throw up. In the morning, she just took her regular medicine (Unspecified Medications). She could eat barely anything like she said after three or four days. Consumer stated that her height was 5 feet 3 inches, and she shrank some. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive, x-ray resulted bronchitis. The outcome of the event headache was resolved whereas the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-06-08 | insomnia |
She cant sleep; Experiencing pain when lying down that feels like everything hurts as she cant bend...
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She cant sleep; Experiencing pain when lying down that feels like everything hurts as she cant bend down to pick something up; Her ESR was elevated as well as her CRP; Her ESR was elevated as well as her CRP; The back of her neck, near the top of her back feels stiff; Inflammation; Pain in her arm/the pain went to her other arm/the thigh muscles hurt/it hurts/the same thing with her legs and cannot bend down; Glute muscle started hurting; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 07Feb2021 around 10:30 (Lot number/NDC number/Expiry date: Unknown) as single dose for Covid-19 immunization (preventative). The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 administered in left arm on 17Jan2021 around 12:00 PM as single dose for Covid-19 immunization and experienced under her arm hurt terribly under the muscle and tetanus vaccine (TETANUS SHOT). Caller stated that "she was already done with the 2 doses of the Pfizer Covid 19 vaccine. She said that she experienced side effects after getting the vaccine. She was experiencing pain in her arm and that 3 weeks after her second dose the pain went to her other arm. Every time she wanted to sit down she was having trouble going up as her glute muscle started hurting. She could not sleep, experiencing pain when lying down that felt like everything hurts as she could not bend down to pick something up. They also gave her blood test which they saw that her ESR was elevated as well as her CRP. She was asked about the same reports as that and what medication she should be taking. DSU: E-transmitting DSU as the caller ended the line before she could offer to transfer. Was not able to ask for her zip code and offer survey as caller ended the line. Clinical Trials Experience included: Table 4: Study 2, Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose. Participants 56 Years of Age and Older. Reactogenicity Subset of the Safety Population. Caller was the patient that wanted to know who to write or talk to about having an adverse reaction after the Covid vaccine. Caller did not explain reaction to agent. Caller was asking what to do about the reaction and agent provided number. Height: She thought she was shrunk. Reported she finally got her HCP to order blood tests for her. She finally took the necessary blood tests. Confirmed product as Pfizer Covid19 vaccine. She took the first vaccine and under her arm hurt terribly under the muscle and it lasted 2 or 3 days and then it went away. When she took the second vaccine the same thing happened, and her arm hurting lasted about 3 or 4 days. She had a very high tolerance to pain and tend to ignore things. It gave her a problem like she could not reach, it hurt when tried to reach things. About 2 or 3 weeks after the second dose both of her arms felt the same way, under the arms muscles when driving it hurt her under both of her arms. It was ongoing, it was terrible, and it got worse. She started documenting it. About 3 weeks ago, when she sat down, she could not get up, underneath her backside and the thigh muscles hurt. It was ongoing and everything seems to be getting worse. Reaching was terrible, she was not sleeping. She was having a terrible, terrible pain under her arm when she asleep and she went from bed to couch. She read that it might help to try to use a pillow when trying to get up. Stated that, the only way she could get up from bed was if she leans on a pillow. In the morning it was the worse and she could not get out of bed, like she did not have the strength to get out of bed. She was then walking, and she walked through it, her behind, it hurt. She was scared since it was gravitating from her upper arm to her lower arm. Reported that, it seems to be the same thing with her legs and could not bend down to pick something up. Everyone kept telling her it was from driving. She did not have her vaccination card to provide lot, expiration date or dosage for either dose. First dose was administered on 17Jan2021 around 12:00 PM, administered in left arm. Second dose administered on 07Feb2021 around 10:30, administered in left arm". Treatment included "tried going into jacuzzi and Epsom salt baths but nothing helps. One time in the jacuzzi it seemed to get better but then the same thing happened the next day. She did not take any prescriptions. She was now concerned that the back of her neck, near the top of her back feels stiff now too. She was not sure if pain was radiating. What was crazy is that her arm pain was only for a short time prior and that was weeks before. She did not realize the pain was gravitating that it was moving. Hoping we can come up with a cure, did not want it to go on forever, it was scary. She was vey tiny. She had high cabinets and she was used to climbing 6-foot ladders to put things away and now cannot reach it. When she tried to climb a ladder now it was scary it hurt and she cannot go up high enough. The pain started moving and she called the doctor and he told her to take blood test to see what it showed. Provides results as C-reactive protein was up. CRP was up. ESR was elevated. Her husband who was a pharmacist told her those results show inflammation in the body. Adverse events following prior vaccinations: No, she did not take vaccines, never took shingles, flu, or pneumonia vaccine. She only got what she needed as a child and the last shot she had was about 10 years ago, it was a tetanus shot. Seriousness was reported as no. Outcome of the event ESR was elevated as well as her CRP was unknown, whereas other events was not recovered. Information regarding the lot/batch number has been requested.
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| 75 | 2021-06-09 | nervousness |
Problem swallowing; Attack to her lymph nodes; arm was swollen, the one that she received the vaccin...
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Problem swallowing; Attack to her lymph nodes; arm was swollen, the one that she received the vaccine in; Nervous; Respirations were fast; Pounding in her left breast; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, NDC number and expiry date was unknown) via an unspecified route of administration, in left arm on 03Mar2021 at 13:00 (at the age of 75-year-old) as 1 ST DOSE, SINGLE for COVID-19 immunization at workplace hospital. The patient medical history included dry eye which was diagnosed for 2 years. She had dry eyes, they just gave her doxycycline which was new medication she has to taken for 20 days. There were no concomitant medications reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 the patient had experienced pounding in her left breast. On 03Mar2021 19:00 experienced nervous and respirations were fast, on 03Mar2021 23:00 arm was swollen, the one that she received the vaccine in. On 04Mar2021 attack to her lymph nodes, problem swallowing on an unspecified date. It was reported that the patient received the PFIZER COVID vaccine, she wanted to report her event. The patient received the vaccine, then at 17:00 there was no reaction. At 19:00 the patient felt like she was nervous, like her respirations were fast, pounding constantly inside of her left breast for maybe 2 hours. At 23:00 when the patient went to shower she was unable to put her arms up. When she got out her arm was swollen, the one that she received the vaccine in. The patient felt like she was having a problem swallowing when she laid down for bed. The next day around at 6:30 the side that the injection was swollen up to her elbow and she noticed the swelling was up to her neck just in that part. The patient called her primary care provider and at 4:30 she got an appointment to see her doctor. When the patient went to the doctor appointment, the swelling was going down in the up to the elbow. The patient doctor said there was an attack to her lymph nodes, she was told to take Tylenol every 6 hours and today was day 7, and there was still swelling and some pain. The patient's doctor told the patient that she still need to have the second shot. What would be the reaction from the second dose. The patients doctor said the caller would be sick for maybe 2 days after the second dose of the vaccine. The patient arm was still swollen and she still had pain, what should she do. The patient doctor said to take a Tylenol but the caller is allergic to so many medications she was afraid to take it. The patient asked if we have MODERNA'S number so she could call them for her friend. Reporter reported that the patient stated she was a certified medical assistant. The patient prefers to be contacted via phone. When the patient got the vaccine at 13:00 she felt great, then at 19:00 when she was cooking , she felt short of breath, she did her respiration exercises, she was relaxing. The problem was on the left breast it was like a pounding constantly. This only happened for a few hours. There was a pain when the patient tried to put her arms up. The next morning it was around 10:30 the swelling in her left arm was up to the patient elbow, it was tight up to her ears, on the left side of her face. It was very hard and very swollen, even on her neck. That was when she called the doctor, who then diagnosed her with the attack on the lymph nodes, the doctor checked under her arm and there was a pain when she pressed. The patient had swallowing problems at 2:00, she was nervous, she drank some water, they said to drink a lot of water and she went to bed. The patient was scheduled for second dose on 24Mar2021. The patient never took Tylenol, she did not have pain that was killing her, just swelling. There was not any relevant test performed. No adverse event prior to the vaccination. The patient visit to physician office but not emergency room. The patient received the treatment for the attack to her lymph nodes. The outcome of events was unknown. No follow-up attempts are possible; No further information is expected
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